Lexaria Bioscience Corp. - Quarter Report: 2019 May (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
For the quarterly period ended May 31, 2019 or ¨ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number ________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Lexaria Bioscience Corp. | |||||||||||||||||
(Exact name of registrant as specified in its charter) |
Nevada |
| 20-2000871 | |||||||||||||||
(State or other jurisdiction of incorporation or organization) |
| (IRS Employer Identification No.) | |||||||||||||||
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#100 – 740 McCurdy Ave., Kelowna, British Columbia, Canada |
| V1X 2P7 | |||||||||||||||
(Address of principal executive offices) |
| (Zip Code) |
250-765-6424 | |||||||||||||||||
(Registrant’s telephone number, including area code) | |||||||||||||||||
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N/A | |||||||||||||||||
(Former name, former address and former fiscal year, if changed since last report) |
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. x YES ¨ NO
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). x YES ¨ NO
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a small reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act
Large accelerated filer | ¨ | Accelerated filer | ¨ | ||||||||||||||
Non-accelerated filer | ¨ | (Do not check if a smaller reporting company) | Smaller reporting company | x | |||||||||||||
| 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 x NO
APPLICABLE ONLY TO CORPORATE ISSUERS
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
78,637,134 common shares issued and outstanding as of July 8, 2019
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3 |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations. | 21 |
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47 |
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Unregistered Sales of Equity Securities and Use of Proceeds. | 47 |
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Page 2 of 49 |
2 |
PART 1 – FINANCIAL INFORMATION
Lexaria Bioscience Corp.’s (“Lexaria” or the “Company”) unaudited interim consolidated financial statements for the nine-month period ended May 31, 2019, form part of this quarterly report. They are stated in United States Dollars and are prepared in accordance with United States generally accepted accounting principles (US GAAP).
Page 3 of 49 |
3 |
Table of Contents |
LEXARIA BIOSCIENCE CORP. | ||||||
CONSOLIDATED BALANCE SHEETS | ||||||
(Expressed in U.S. Dollars) |
|
| May 31 |
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| August 31 |
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| 2019 |
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| 2018 |
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| (Unaudited) |
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| (Audited) |
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ASSETS |
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Current |
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Cash and cash equivalents |
| $ | 1,995,842 |
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| $ | 1,727,184 |
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Marketable securities (Note 19) |
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| 74,840 |
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| 10,151 |
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Accounts and other receivables (Note 6) |
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| 225,834 |
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| 265,751 |
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Inventory (Note 7) |
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| 188,275 |
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| 87,233 |
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Prepaid expenses (Note 18) |
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| 122,808 |
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| 193,732 |
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Total Current Assets |
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| 2,607,599 |
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| 2,284,051 |
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Patents (Note 8) |
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| 242,748 |
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| 146,538 |
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Property & equipment (Note 9) |
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| 606,751 |
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| 1,237 |
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| 849,499 |
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| 147,775 |
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TOTAL ASSETS |
| $ | 3,457,098 |
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| $ | 2,431,826 |
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LIABILITIES |
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Current |
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Accounts payable and accrued liabilities (Note 10) |
| $ | 111,298 |
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| $ | 35,785 |
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Due to related parties (Note 15) |
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| 20,995 |
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| 7,855 |
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Total Current Liabilities |
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| 132,293 |
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| 43,640 |
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TOTAL LIABILITIES |
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| 132,293 |
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| 43,640 |
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STOCKHOLDERS' EQUITY |
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Share Capital |
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Authorized: |
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220,000,000 common voting shares with a par value of $0.001 per share Issued and outstanding: 78,437,134 common shares at May 31, 2019 and 75,533,471 common shares at August 31, 2018 |
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| 78,437 |
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| 75,533 |
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Additional paid-in capital |
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| 25,890,921 |
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| 22,095,682 |
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Accumulated other comprehensive loss |
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| - |
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| (14,247 | ) |
Deficit |
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| (22,789,954 | ) |
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| (19,768,782 | ) |
Equity attributable to shareholders |
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| 3,179,404 |
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| 2,388,186 |
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Non-controlling Interest |
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| 145,401 |
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| - |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
| $ | 3,457,098 |
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| $ | 2,431,826 |
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The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
Page 4 of 49 |
4 |
Table of Contents |
LEXARIA BIOSCIENCE CORP. | ||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (unaudited) | ||||||||
(Expressed in U.S. Dollars, except number of shares) |
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|
| THREE MONTHS ENDED |
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| NINE MONTHS ENDED |
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| May 31, |
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| May 31, |
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| May 31, |
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| May 31, |
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| 2019 |
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| 2018 |
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| 2019 |
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| 2018 |
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Revenue (Note 14) |
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| $ | 59,931 |
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| $ | 140,340 |
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| $ | 97,489 |
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| $ | 336,933 |
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Cost of Goods Sold |
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| 3,096 |
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| 2,427 |
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| 7,944 |
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| 22,239 |
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Gross profit |
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| 56,835 |
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| 137,913 |
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| 89,545 |
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| 314,694 |
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Expenses |
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Accounting and audit |
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| 4,407 |
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| 14,773 |
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| 31,474 |
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| 48,942 |
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Depreciation and Amortization (Note 8, 9) |
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| 22,666 |
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| 527 |
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| 34,355 |
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| 1,364 |
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Advertising and promotions |
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| 114,706 |
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| 175,770 |
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| 399,848 |
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| 432,494 |
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Consulting (Notes 12, 13, 15) |
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| 280,893 |
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| 3,115,389 |
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| 1,127,311 |
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| 4,455,808 |
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Investor relations |
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| 62,309 |
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| - |
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| 62,309 |
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| 188 |
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Legal and professional |
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| 192,677 |
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| 65,091 |
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| 546,710 |
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| 207,134 |
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Office and miscellaneous |
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| 81,876 |
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| 64,779 |
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| 207,036 |
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| 182,754 |
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Research and development |
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| 231,035 |
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| 93,067 |
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| 394,091 |
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| 279,221 |
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Travel |
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| 33,371 |
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| 29,804 |
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| 72,870 |
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| 80,181 |
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Employees |
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| 224,544 |
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| - |
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| 250,171 |
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| - |
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Gain on disposal of assets |
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| - |
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| - |
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| - |
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| (3,998 | ) |
Unrealized loss (gain) on marketable securities (Note 19) |
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| (3,713 | ) |
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| - |
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| 5,808 |
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| - |
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Inventory write-off (Note 7) |
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| - |
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| 3,625 |
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| - |
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| 12,609 |
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| 1,244,771 |
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| 3,562,825 |
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| 3,131,983 |
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| 5,696,697 |
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Net loss and comprehensive loss for the period |
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| (1,187,936 | ) |
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| (3,424,912 | ) |
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| (3,042,438 | ) |
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| (5,382,003 | ) |
Net loss and comprehensive loss attributable to: |
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Common shareholders |
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| (1,177,046 | ) |
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| (3,424,912 | ) |
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| (3,021,172 | ) |
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| (5,382,003 | ) |
Non-controlling interest |
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| (16,131 | ) |
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| - |
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| (21,266 | ) |
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| - |
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Basic and diluted loss per share |
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| (0.01 | ) |
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| (0.05 | ) |
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| (0.04 | ) |
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| (0.08 | ) |
Weighted average number of common shares outstanding |
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-Basicanddiluted |
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| 80,550,438 |
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| 71,042,049 |
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| 77,509,193 |
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| 70,239,898 |
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The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
Page 5 of 49 |
5 |
Table of Contents |
LEXARIA BIOSCIENCE CORP. | |||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited) | |||||||||
(Expressed in U.S. Dollars) |
|
| NINE MONTHS ENDED |
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| May 31 |
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| May 31 |
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| 2019 |
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| 2018 |
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Cash flows used in operating activities |
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Net loss for the period |
| $ | (3,042,438 | ) |
| $ | (5,382,003 | ) |
Adjustments to reconcile net loss to net cash |
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Used in operating activities: |
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Stock based compensation |
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| 507,310 |
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| 2,102,704 |
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Depreciation and amortization |
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| 34,355 |
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| 1,364 |
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Inventory write-off (Note 7) |
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| - |
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| 12,609 |
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Non-cash consideration for licensing – revenue |
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| - |
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| (25,000 | ) |
Shares to be issued for services – consulting |
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| - |
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| 640,000 |
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Shares issued for services |
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| 131,000 |
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| 183,426 |
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Warrants issued for services |
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| 52,817 |
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| 1,063,270 |
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Unrealized loss on marketable securities |
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| 5,808 |
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|
| - |
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Change in working capital: |
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Accounts and other receivables |
|
| (16,333 | ) |
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| (222,484 | ) |
Inventory |
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| (101,042 | ) |
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| (21,910 | ) |
Prepaid expenses |
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| 70,924 |
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| (12,191 | ) |
Accounts payable and accrued liabilities |
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| 75,513 |
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| 29,959 |
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Due to related parties |
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| 13,140 |
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| (33,580 | ) |
Unearned revenue |
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| - |
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| (17,083 | ) |
Net cash used in operating activities |
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| (2,268,946 | ) |
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| (1,680,919 | ) |
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Cash flows used in investing activities |
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Investment in Poviva |
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| - |
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| (70,000 | ) |
Patent |
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| (99,418 | ) |
|
| (58,640 | ) |
Property & Equipment |
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| (636,661 | ) |
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| - |
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Net cash used in investing activities |
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| (736,079 | ) |
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| (128,640 | ) |
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Cash flows from financing activities |
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Proceeds from issuance of equity |
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| 3,273,683 |
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| 1,339,591 |
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Net cash from financing activities |
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| 3,273,683 |
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| 1,339,591 |
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Increase (decrease) in cash |
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| 268,658 |
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| (469,968 | ) |
Cash, beginning of period |
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| 1,727,184 |
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|
| 2,533,337 |
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Cash, end of period |
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| 1,995,842 |
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| $ | 2,063,369 |
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Supplemental information of cash flows: |
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Common shares issued to settle accounts payable (shares issued for service) |
| $ | - |
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| $ | 12,000 |
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Income tax paid in cash |
| $ | 13,869 |
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| $ | - |
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Reclassification of NCI to additional paid in capital |
| $ | 833,333 |
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| $ | 238,476 |
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The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
Page 6 of 49 |
6 |
Table of Contents |
LEXARIA BIOSCIENCE CORP.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Expressed in U.S. Dollars)
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| COMMON STOCK |
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| SHARES |
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| AMOUNT $ |
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| ADDITIONAL PAID-IN CAPITAL |
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| DEFICIT $ |
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| NCI $ |
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| AOCI $ |
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| TOTAL STOCKHOLDERS’ EQUITY $ |
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Balance August 31, 2017 |
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| 67,975,761 |
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| 67,976 |
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| 16,108,270 |
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|
| (13,169,939 | ) |
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| (238,476 | ) |
|
| - |
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|
| 2,767,831 |
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Non-controlling Interest |
|
| - |
|
|
| - |
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|
| (308,476 | ) |
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| - |
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| 238,476 |
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|
| - |
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|
| (70,000 | ) |
Exercise of stock options |
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| 55,000 |
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| 55 |
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| 12,446 |
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| - |
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| - |
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| - |
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| 12,501 |
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Exercise of warrants |
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| 1,404,437 |
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| 1,404 |
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| 268,497 |
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| - |
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| - |
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| - |
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| 269,901 |
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Net loss |
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| - |
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|
| - |
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|
| - |
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| (578,713 | ) |
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| - |
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| - |
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|
| (578,713 | ) |
Balance November 30, 2017 |
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| 69,435,198 |
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| 69,435 |
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| 16,080,737 |
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| (13,748,652 | ) |
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| - |
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| - |
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|
| 2,401,520 |
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Shares issued for services |
|
| 223,690 |
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| 224 |
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| 183,202 |
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|
| - |
|
|
| - |
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|
| - |
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|
| 183,426 |
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Stock based compensation |
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| - |
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|
| - |
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|
| 122,562 |
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|
| - |
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| - |
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| - |
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| 122,562 |
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Warrants issued for services |
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| - |
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|
| - |
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|
| 717,880 |
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|
| - |
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|
| - |
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|
| - |
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|
| 717,880 |
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Exercise of stock options |
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| 243,375 |
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| 243 |
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| 58,458 |
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|
| - |
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| - |
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| - |
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| 58,701 |
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Exercise of warrants |
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| 1,195,042 |
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| 1,195 |
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| 665,293 |
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|
| - |
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|
| - |
|
|
| - |
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| 666,488 |
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Net loss |
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| - |
|
|
| - |
|
|
| - |
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| (1,378,378 | ) |
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| - |
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|
| - |
|
|
| (1,378,378 | ) |
Balance February 28, 2018 |
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| 71,097,305 |
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|
| 71,097 |
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|
| 17,828,132 |
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| (15,127,030 | ) |
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| - |
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|
| - |
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|
| 2,772,199 |
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Shares issued for services |
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| 500,000 |
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|
| 500 |
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|
| 639,500 |
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|
| - |
|
|
| - |
|
|
| - |
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|
| 640,000 |
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Stock based compensation (Note 13) |
|
| - |
|
|
| - |
|
|
| 1,980,142 |
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|
| - |
|
|
| - |
|
|
| - |
|
|
| 1,980,142 |
|
Warrants issued for services |
|
| - |
|
|
| - |
|
|
| 345,390 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 345,390 |
|
Exercise of warrants |
|
| 1,300,000 |
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|
| 1,300 |
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|
| 330,700 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 332,000 |
|
Net loss |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (3,424,912 | ) |
|
| - |
|
|
| - |
|
|
| (3,424,912 | ) |
Other comprehensive loss |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| (7,383 | ) |
|
| (7,383 | ) |
Balance May 31, 2018 |
|
| 72,897,305 |
|
|
| 72,897 |
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|
| 21,123,864 |
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|
| (18,551,942 | ) |
|
| - |
|
|
| (7,383 | ) |
|
| 2,637,436 |
|
Shares issued for services |
|
| 424,000 |
|
|
| 424 |
|
|
| 597,206 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 597,630 |
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Shares to be issued for services |
|
| (500,000 | ) |
|
| (500 | ) |
|
| (639,500 | ) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (640,000 | ) |
Non-controlling interest |
|
| - |
|
|
| - |
|
|
| (10,344 | ) |
|
| - |
|
|
| - |
|
|
| 10,344 |
|
|
| - |
|
Stock based compensation (Note 13) |
|
| - |
|
|
| - |
|
|
| 499,535 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 499,535 |
|
Exercise of stock options |
|
| 247,500 |
|
|
| 247 |
|
|
| 22,252 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 22,499 |
|
Exercise of warrants |
|
| 2,464,666 |
|
|
| 2,465 |
|
|
| 502,669 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 505,134 |
|
Net loss |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (1,216,840 | ) |
|
| - |
|
|
| (10,344 | ) |
|
| (1,227,184 | ) |
Other comprehensive income |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| (6,864 | ) |
|
| (6,864 | ) |
Balance, August 31, 2018 |
|
| 75,533,471 |
|
|
| 75,533 |
|
|
| 22,095,682 |
|
|
| (19,768,782 | ) |
|
| - |
|
|
| (14,247 | ) |
|
| 2,388,186 |
|
The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
Page 7 of 49 |
7 |
Table of Contents |
LEXARIA BIOSCIENCE CORP.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY
(Expressed in U.S. Dollars)
|
| COMMON STOCK |
|
| ADDITIONAL PAID-IN |
|
|
|
|
|
|
|
|
|
|
| TOTAL STOCKHOLDERS’ |
| ||||||||||
|
| SHARES |
|
| AMOUNT $ |
|
| CAPITAL $ |
|
| DEFICIT $ |
|
| NCI $ |
|
| AOCI $ |
|
| EQUITY $ |
| |||||||
Balance, August 31, 2018 |
|
| 75,533,471 |
|
|
| 75,533 |
|
|
| 22,095,682 |
|
|
| (19,768,782 | ) |
|
| - |
|
|
| (14,247 | ) |
|
| 2,388,186 |
|
Stock based compensation |
|
| - |
|
|
| - |
|
|
| 64,044 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 64,044 |
|
Private placement of shares, net of issuance cost |
|
| 947,150 |
|
|
| 947 |
|
|
| 1,469,363 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 1,470,310 |
|
Exercise of stock options |
|
| 330,000 |
|
|
| 330 |
|
|
| 32,670 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 33,000 |
|
Exercise of warrants |
|
| 309,800 |
|
|
| 310 |
|
|
| 145,570 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 145,880 |
|
Net loss |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (701,391 | ) |
|
|
|
|
|
| - |
|
|
| (701,391 | ) |
AOCI |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 14,247 |
|
|
| 14,247 |
|
Balance November 30, 2018 |
|
| 77,120,421 |
|
|
| 77,120 |
|
|
| 23,807,329 |
|
|
| (20,470,173 | ) |
|
| - |
|
|
| - |
|
|
| 3,414,276 |
|
Shares issued for services |
|
| 100,000 |
|
|
| 100 |
|
|
| 130,900 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 131,000 |
|
Exercise of stock options |
|
| 50,000 |
|
|
| 50 |
|
|
| 18,450 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 18,500 |
|
Exercise of warrants |
|
| 731,665 |
|
|
| 732 |
|
|
| 362,067 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 362,799 |
|
Net loss |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (1,147,976 | ) |
|
| - |
|
|
| - |
|
|
| (1,147,976 | ) |
Net loss non-controlling interest |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| (5,135 | ) |
|
| - |
|
|
| (5,135 | ) |
Non-controlling Interest (Note 3) |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 1,000,000 |
|
|
| - |
|
|
| 1,000,000 |
|
Balance February 28, 2019 |
|
| 78,002,086 |
|
|
| 78,002 |
|
|
| 24,318,746 |
|
|
| (21,618,149 | ) |
|
| 994,865 |
|
|
| - |
|
|
| 3,773,464 |
|
Exercise of stock options |
|
| 50,000 |
|
|
| 50 |
|
|
| 14,700 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 14,750 |
|
Exercise of warrants |
|
| 385,048 |
|
|
| 385 |
|
|
| 228,058 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 228,444 |
|
Warrants Issued for Service |
|
| - |
|
|
| - |
|
|
| 52,817 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 52,817 |
|
Stock based compensation |
|
| - |
|
|
| - |
|
|
| 443,266 |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| 443,266 |
|
Net loss |
|
| - |
|
|
| - |
|
|
| - |
|
|
| (1,171,805 | ) |
|
| - |
|
|
| - |
|
|
| (1,171,805 | ) |
Net loss non-controlling interest |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
|
| (16,131 | ) |
|
| - |
|
|
| (16,131 | ) |
Non-controlling Interest (Note 3) |
|
| - |
|
|
| - |
|
|
| 833,333 |
|
|
| - |
|
|
| (833,333 | ) |
|
| - |
|
|
| - |
|
Balance May 31, 2019 |
|
| 78,437,134 |
|
|
| 78,437 |
|
|
| 25,890,921 |
|
|
| (22,789,954 | ) |
|
| 145,401 |
|
|
| - |
|
|
| 3,324,805 |
|
The accompanying notes are an integral part of these unaudited interim consolidated financial statements.
Page 8 of 49 |
8 |
Table of Contents |
LEXARIA BIOSCIENCE CORP.
NOTES TO THE UNAUDITED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
May 31, 2019
(Expressed in U.S. Dollars)
1. Organization, Business and Going Concern
Lexaria Bioscience Corp. (“Lexaria”, or the “Company”) was formed on December 9, 2004 under the laws of the State of Nevada. In March of 2014, the Company began its entry into the bioscience and alternative health and wellness business and in May 2016, the Company commenced out-licensing its patented DehydraTECH™ technology (the “Technology”) for improved delivery of bioactive compounds that promotes healthy ingestion methods, lower overall dosing and higher effectiveness in active molecule delivery. The Company has its office in Kelowna, BC, Canada.
The unaudited interim consolidated financial statements included herein have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States generally accepted accounting principles (US GAAP) have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, all adjustments considered necessary for a fair presentation have been included. Interim results are not necessarily indicative of results for a full year.
These unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated annual financial statements and notes thereto included in our annual report filed on Form 10-K for the year ended August 31, 2018.
The Company’s unaudited interim consolidated financial statements have been prepared in accordance with US GAAP applicable to a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. The recurring losses from operations and net capital deficiency raise substantial doubt about the Company’s ability to continue as a going concern.
The Company requires additional funds to maintain its operations and developments. Management’s plans in this regard are to raise equity and debt financing as required, but there is no certainty that such financing will be available or that it will be available at acceptable terms. The outcome of these matters cannot be predicted at this time.
2. Business Risk and Liquidity
The Company is subject to several categories of risk associated with its operating activities. The production and sale of alternative health products is an emerging industry in which business practices are not yet standardized and are subject to frequent scrutiny and evaluation by federal, state, provincial, and municipal authorities, academics, and media outlets, among others. Although we intend to develop our businesses in accordance with best ethical practices, we may suffer negative publicity if we, our partners, contractors, or customers are found to have engaged in any environmentally insensitive practices or other business practices that are viewed as unethical.
Our operations may require licenses and permits from various governmental authorities. We believe that we will be able to obtain all necessary licenses and permits under applicable laws and regulations for our operations and believe we will be able to comply in all material respects with the terms of such licenses and permits. However, such licenses and permits are subject to change in various circumstances. There can be no guarantee that we will be able to obtain or maintain all necessary licenses and permits, and failing to obtain or retain required licenses could have a materially adverse effect on the Company.
Page 9 of 49 |
9 |
Table of Contents |
Lexaria and its subsidiaries are not involved directly or indirectly in the cultivation, processing, distribution, or utilization of Cannabis or Cannabis derived components. All of Lexaria’s consumer products utilize legally sourced Hemp and Hemp components in their production. Lexaria does have an ancillary involvement risk via out-licensing of its patented Technology to licensees that choose to utilize its Technology to manufacture products that contain locally or state approved but federally regulated and controlled contents. There can be no guarantee that changes in the regulatory framework and environment will not occur and such changes could have a materially adverse effect on the Company. It is possible some jurisdictions may even interpret Lexaria’s ancillary involvement as in contravention with regulations.
3. Basis of Consolidation
These consolidated financial statements include the financial statements of the Company and its wholly owned subsidiaries; Lexaria CanPharm ULC, PoViva Corp., Lexaria Hemp Corp., Kelowna Management Services Corp. and Lexaria Pharmaceutical Corp, and our subsidiary Lexaria Nicotine LLC. On January 15, 2019, the Company announced the initial investment of $1,000,000 from Altria Ventures Inc., an indirect wholly owned subsidiary of Altria Group, Inc., for a 16.667% equity interest along with certain other rights in Lexaria Nicotine LLC. All significant intercompany balances and transactions have been eliminated.
4. Estimates and Judgments
The preparation of financial statements in conformity with U.S GAAP requires us to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Some of the Company’s accounting policies require us to make subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. These accounting policies involve critical accounting estimates because they are particularly dependent on estimates and assumptions made by management about matters that are highly uncertain at the time the accounting estimates are made. Although we have used our best estimates based on facts and circumstances available to us at the time, different estimates reasonably could have been used. Changes in the accounting estimates used by the Company are reasonably likely to occur from time to time, which may have a material effect on the presentation of financial condition and results of operations.
The Company reviews these estimates, judgments and assumptions periodically and reflect the effects of revisions in the period in which they are deemed to be necessary. We believe that these estimates are reasonable; however, actual results could differ from these estimates.
In preparing these unaudited interim consolidated financial statements, the significant judgments made by management in applying the Company’s accounting policies and the key sources of estimation uncertainty were the same as those applied to the consolidated financial statements for the year ended August 31, 2018, with the following update:
Property & Equipment
Property and Equipment are stated at cost less accumulated amortization and amortized using the straight-line method over their useful lives or by units of production.
Page 10 of 49 |
10 |
Table of Contents |
5. Recent Accounting Guidance
In January 2016, FASB issued an ASU, Subtopic 82510, to amend certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. Most prominent among the amendments is the requirement for changes in fair value of equity investments, with certain exceptions, to be recognized through profit or loss rather than other comprehensive income. The Company adopted the standard September 1, 2018. The impact was not material and the $14,247 impact on the Company’s financial statements was included in income in the current period.
In February 2016 FASB issued ASU No. 201602, Leases (Topic 842) which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation, and disclosure of leases for both lessees and the lessors. The new standard requires the lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. The classification will determine whether lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease, respectively. A lessee is also required to record a right of use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. When adopted, the Company does not expect this guidance to have a material impact on its consolidated financial statements.
In June 2016, the FASB issued a new standard to replace the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss credit loss estimates. For trade and other receivables, loans and other financial instruments, the Company will be required to use a forward-looking expected loss model rather than the incurred loss model for recognizing credit losses which reflects losses that are probable. Credit losses relating to available for sale debt securities will also be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. The new standard will be effective for Lexaria beginning September 1, 2020, with early adoption permitted. Application of the amendments is through a cumulative effect adjustment to deficit as of the effective date. The Company is currently assessing the impact of the standard on its consolidated financial statements.
In February 2018, the FASB issued ASU No. 201802, Income Statement–Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, which allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act enacted by the U.S. federal government on December 22, 2017 (the “2017 Tax Act”). Consequently, the amendments eliminate the stranded tax effects resulting from the 2017 Tax Act and will improve the usefulness of information reported to financial statement users. The amendments in this ASU are effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period, (1) for public business entities for reporting periods for which financial statements have not yet been issued and (2) for all other entities for reporting periods for which financial statements have not yet been made available for issuance. The Company is currently evaluating the effect this ASU will have on its consolidated financial statements and related disclosures but does not expect it to have a material impact on its consolidated financial statements.
In June 2018, the FASB issued ASU No. 201807, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share Based Payment Accounting. This is a simplification that involves several aspects of accounting for nonemployee share-based payments resulting from expanding the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The new standard will be effective for Lexaria for September 1, 2019. The Company does not expect it to have a material impact on its consolidated financial statements.
Page 11 of 49 |
11 |
Table of Contents |
6. Accounts and Other Receivables
|
| May 31 2019 $ |
|
| August 31 2018 $ |
| ||
Trade and deposits receivable |
|
| 5,727 |
|
|
| 5,200 |
|
Territory License Fee receivable (Note 14) |
|
| 118,000 |
|
|
| 199,375 |
|
Sales tax receivable |
|
| 102,107 |
|
|
| 61,176 |
|
|
|
| 225,834 |
|
|
| 265,751 |
|
7. Inventory
|
| May 31 2019 $ |
|
| August 31 2018 $ |
| ||
Raw materials |
|
| 65,899 |
|
|
| 29,355 |
|
Work in progress |
|
| 25,928 |
|
|
| 48,126 |
|
Finished goods |
|
| 96,448 |
|
|
| 9,752 |
|
|
|
| 188,275 |
|
|
| 87,233 |
|
During the nine months ended May 31, 2019, the Company wrote down $Nil (May 2018 - $12,609) of inventory to reflect its net realizable value.
8. Intellectual Property
On November 12, 2014, the Company signed an agreement with Poppy’s Teas LLC. whereby it acquired a 51% interest. Subsequent to signing the agreement, Poppy’s Teas LLC effected a name change to PoViva Tea LLC. The Company acquired the remaining49% ownership interest in PoViva Tea, LLC in October 2017 via compensation of $70,000, a waiver on certain debts owed to Lexaria, and a 5%, 20 year royalty on net profits of ViPova Tea™ tea, coffee, and hot chocolate sales. No Lexaria stock or options were issued. On September 18, 2018 Poviva Tea, LLC converted from a Nevada limited liability company to a Nevada corporation and effected a name change to Poviva Corp.
The following is a list of US capitalized patents held by the Company
Issued Patent # | Patent Issuance Date | Patent Family |
US 9,474,725 B1 | 10/25/2016 |
Food and Beverage Compositions Infused With
Lipophilic Active Agents and Methods of Use Thereof |
US 9,839,612 B2 | 12/12/2017 | |
US 9,972,680 B2 | 5/15/2018 | |
US 9,974,739 B2 | 5/22/2018 | |
US 10,084,044 B2 | 9/25/2018 | |
US 10,103,225 B2 | 10/16/2018 |
The Company also holds non-capitalized patents outside the US.
Page 12 of 49 |
12 |
Table of Contents |
Patents
|
| May 31 2019 $ |
|
| August 31 2018 $ |
| ||
Balance – Beginning |
|
| 146,538 |
|
|
| 62,827 |
|
Additions |
|
| 99,418 |
|
|
| 85,399 |
|
Amortization* |
|
| (3,208 | ) |
|
| (1,688 | ) |
Balance – Ending |
|
| 242,748 |
|
|
| 146,538 |
|
* The patents are amortized over their legal life of 20 years.
9. Property & Equipment
Cost | Opening Amortization $ |
|
| Period Amortization $ |
|
| August 31 | |||||
Equipment | 3,094 | |||||||||||
Less: accumulated amortization | (1,238 | ) | (619 | ) | (1,857 | ) | ||||||
Balance - Ending | 1,237 |
Cost |
| Opening Amortization $ |
|
| Period Amortization $ |
|
| May 31 |
| |||
Leasehold Improvements |
|
|
|
|
|
|
|
|
|
| 263,748 |
|
Less: accumulated amortization |
|
| - |
|
|
| (19,063 | ) |
|
| (19,063 | ) |
Computer Equipment |
|
|
|
|
|
|
|
|
|
| 64,346 |
|
Less: accumulated amortization |
|
| - |
|
|
| (6,918 | ) |
|
| (6,918 | ) |
Furniture Fixtures Equipment |
|
|
|
|
|
|
|
|
|
| 34,221 |
|
Less: accumulated amortization |
|
| (1,857 | ) |
|
| (2,446 | ) |
|
| (4,303 | ) |
Lab Equipment |
|
|
|
|
|
|
|
|
|
| 277,562 |
|
Less: accumulated amortization |
|
| - |
|
|
| (2,843 | ) |
|
| (2,843 | ) |
Balance |
|
| (1,857 | ) |
|
| (31,270 | ) |
|
| 606,751 |
|
10. Accounts Payable and Accrued Liabilities
|
| May 31 2019 $ |
|
| August 31 2018 $ |
| ||
Accounts Payable |
|
|
|
|
|
| ||
Trades Payable |
|
| 87,374 |
|
|
| 33,916 |
|
Sales Tax Payable |
|
| 18,813 |
|
|
| 1,869 |
|
Equipment Payable |
|
| 5,111 |
|
|
| - |
|
|
|
| 111,298 |
|
|
| 35,785 |
|
Page 13 of 49 |
13 |
Table of Contents |
11. Unearned Revenue
On May 14, 2016, the Company entered into a licensing agreement (the “Licensing Agreement”) with an arm’s length party (the “Licensee”) allowing the Licensee, for a two-year period, to utilize the Company’s Technology to create, test, manufacture, and sell marijuana-infused consumable and/or topical products, in the state of Colorado, with an option of extending the terms of the Licensing Agreement to Washington, Oregon, and California (the “License”). In addition to the granting of the License, the Company is required to provide support services to the Licensee in connection with the use of the Company’s Technology during the term of the Licensing Agreement.
The Company determined that the provision of the support services is a separate deliverable under the Licensing Agreement. Accordingly, the Company recognized revenue on a prorated basis over the term of the Licensing Agreement. The Company has since determined that the support services form an insignificant portion of the licensing contract as they are primarily completed prior to delivery of the Technology and that delivery of the License is complete when the Technology is transferred to the Licensee.
|
| May 31 2019 $ |
|
| August 31 2018 $ |
| ||
Balance – Beginning |
|
| - |
|
|
| 17,803 |
|
Earned revenue |
|
| - |
|
|
| (17,803 | ) |
Balance – Ending |
|
| - |
|
|
| - |
|
12. Common Shares and Warrants
Fiscal 2019 Activity
On October 31, 2018, the Company closed a non-brokered private placement for gross proceeds of $1,515,440 (the “Offering”). The Offering consisted of 947,150 units (each, a “Unit”) at an issue price of $1.60 per Unit. Each Unit consists of one common share of the Company (a “Share”) and one common share purchase warrant (each, a “Warrant”). Each Warrant entitles the holder to acquire one common share of the Company at a price of $2.25 per common share for a period of 24 months following the closing of the Offering. Finder’s fees of $45,130 and 28,175 finder’s warrants were paid on a portion of the proceeds raised, with each finder’s warrant having exercise terms identical to the Warrants issued. The Warrants were valued at $16,095, which were recorded as a share issue cost within additional paid in capital for a net effect of $Nil.
Type of Issuance |
| Number of |
|
| Total |
| ||
Warrant Exercise(1) |
|
| 1,426,513 |
|
| $ | 737,122 |
|
Option Exercise |
|
| 430,000 |
|
|
| 66,250 |
|
Private Placement |
|
| 947,150 |
|
|
| 1,515,440 |
|
Per Agreement(2) |
|
| 100,000 |
|
|
| 131,000 |
|
|
|
| 2,903,663 |
|
| $ | 2,449,812 |
|
__________________
(1) Includes 384,212 broker warrants exercised for gross proceeds of $144,799
(2) The Company awarded the restricted common shares as required by consulting contracts.
Page 14 of 49 |
14 |
Table of Contents |
A continuity schedule for warrants is presented below:
|
| Number of Warrants |
|
| Weighted Average Exercise Price $ |
| ||
Balance, August 31, 2017 |
|
| 8,844,506 |
|
|
| 0.29 |
|
Cancelled/Expired |
|
| (230,000 | ) |
|
| 0.17 |
|
Exercised |
|
| (6,364,145 | ) |
|
| 0.28 |
|
Issued |
|
| 1,035,913 |
|
|
| 1.48 |
|
Balance, August 31, 2018 |
|
| 3,286,274 |
|
|
| 0.72 |
|
Cancelled/Expired |
|
| (17,498 | ) |
|
| 0.59 |
|
Exercised |
|
| (1,426,513 | ) |
|
| 0.52 |
|
Issued |
|
| 1,183,062 |
|
|
| 1.98 |
|
Balance, May 31, 2019 |
|
| 3,025,325 |
|
|
| 1.31 |
|
The fair value of warrants granted as compensation warrants was estimated as of the date of the grant by using the Black-Scholes option pricing model with the following assumptions:
|
| May 31 2019 |
| |
Expected volatility |
| 104% - 117% |
| |
Risk-free interest rate |
| 2.31% - 2.87% |
| |
Expected life |
| 2.00 years |
| |
Dividend yield |
|
| 0.00% | |
Estimated fair value per warrant |
| $0.52 - $0.57 |
|
A summary of warrants outstanding as of May 31, 2019 is presented below:
# of Warrants |
|
| Weighted Average Remaining |
| Weighted Average |
| |
200,000 |
|
| 0.05 years |
|
| 0.295 |
|
250,000 |
|
| 0.50 years |
|
| 0.83 |
|
500,000 |
|
| 0.63 years |
|
| 1.83 |
|
975,325 |
|
| 1.42 years |
|
| 2.25 |
|
100,000 |
|
| 1.98 years |
|
| 0.96 |
|
250,000 |
|
| 1.99 years |
|
| 1.55 |
|
750,000 |
|
| 2.36 years |
|
| 0.14 |
|
3,025,325 |
|
| 1.42 years |
|
| 1.31 |
|
13. Stock Options
The Company has established its 2007 Equity Incentive Plan, whereby the board of directors may grant up to 412,500 stock options to eligible employees and directors, the 2010 Stock Option Plan whereby the board of directors may, from time to time, grant up to 1,512,500 stock options to officers and employees, and its 2014 Stock Option Plan whereby the board of directors may, from time to time, grant up to 2,157,500 stock options to directors, officers, employees, and consultants, the Equity Incentive Plan whereby the board of directors may, from time to time, grant up to 7,838,713 stock options to directors, officers, employees, and consultants. Stock options granted must be exercised no later than five years from the date of grant or such lesser period as determined by the Company’s board of directors. The exercise price of an option is equal to or greater than the closing market price of the Company’s common shares on the day preceding the date of grant. The vesting terms of each grant are set by the board of directors.
Page 15 of 49 |
15 |
Table of Contents |
Fiscal 2019 Activity
The Company granted in the period ending May 31, 2019:
Quantity |
|
| Exercise Price $ |
|
| Life (Years) |
| ||
390,000(1) |
|
| 1.27 |
|
|
| 5 |
| |
240,000(1) |
|
| 1.06 |
|
|
| 5 |
| |
30,000(1) |
|
| 1.16 |
|
|
| 5 |
| |
350,000 |
|
|
| 0.99 |
|
|
| 5 |
|
440,000(1) |
|
| 0.99 |
|
|
| 5 |
| |
48,000(1) |
|
| 0.96 |
|
|
| 5 |
| |
1,498,000 |
|
|
| 1.08 |
|
|
|
|
|
(1)Options granted vest over a period of three years.
Fiscal 2018 Activity
The Company granted in the period ending May 31, 2018, 200,000 stock options with an exercise price of $0.83 and an expiration date of December 1, 2022 to an officer of the Company, pursuant to an existing management contract and stock options with an exercise price of $1.53 to directors, officers, employees and consultants that enable the option holders to purchase up to 1,725,000 common shares of the Company.
A continuity schedule for stock options is presented below:
|
| Options |
|
| Weighted Average $ |
|
| Weighted Average Remaining Contractual Term |
| Aggregate |
| |||
Balance, August 31, 2017 |
|
| 3,320,875 |
|
|
| 0.15 |
|
|
|
|
|
| |
Exercised |
|
| (545,875 | ) |
|
| 0.17 |
|
|
|
|
|
| |
Granted |
|
| 2,025,000 |
|
|
| 1.49 |
|
|
|
|
|
| |
Balance, August 31, 2018 |
|
| 4,800,000 |
|
|
| 0.71 |
|
|
|
|
|
| |
Expired |
|
| (1,415,000 | ) |
|
| 0.66 |
|
|
|
|
|
| |
Exercised |
|
| (380,000 | ) |
|
| 0.14 |
|
|
|
|
|
| |
Granted |
|
| 1,498,000 |
|
|
| 1.08 |
|
|
|
|
|
| |
Balance, May 31, 2019 (Outstanding) |
|
| 4,503,000 |
|
|
| 0.90 |
|
| 3.38 years |
| $ | 1,195,075 |
|
Balance, May 31, 2019 (Exercisable) |
|
| 3,721,000 |
|
|
| 0.91 |
|
| 3.20 years |
| $ | 1,195,075 |
|
The fair value of compensation options granted was estimated as of the date of the grant by using the Black-Scholes option pricing model with the following assumptions:
|
| May 31 2019 |
| |
Expected volatility |
| 103% - 144% |
| |
Risk-free interest rate |
| 2.19% - 2.89% |
| |
Expected life |
| 5.00 years |
| |
Dividend yield |
|
| 0.00% | |
Estimated fair value per option |
| $0.73 - $1.07 |
|
Page 16 of 49 |
16 |
Table of Contents |
14. Revenues
|
| Nine months Ended |
| |||||
|
| May 31 2019 $ |
|
| May 31 2018 $ |
| ||
Product sales |
|
| 7,284 |
|
|
| 14,188 |
|
Licensing revenue (Note 11) |
|
| 90,000 |
|
|
| 321,683 |
|
Freight revenue |
|
| 205 |
|
|
| 1,062 |
|
|
|
| 97,489 |
|
|
| 336,933 |
|
The Company recognized licensing revenue on a pro-rated basis over the term of the Licensing Agreement (Note 11) and additional licensing fees as they were earned. The Company has determined that the support services form an insignificant portion of the licensing contract as they are substantially completed prior to delivery of the Technology and that delivery of the license is complete when the Technology is transferred to the licensee. Additional licensing fees and usage fees are recognized as they are earned. During the period ended May 31, 2019, the Company recognized $Nil of deferred revenue (Note 11), and $90,000 of Licensing and Usage fees. Revenues are significantly concentrated on three customers.
15. Related Party Transactions
For the period ended May 31, 2019, the Company paid/accrued the following:
|
| Contract |
|
| Non-Cash |
|
| May 31, 2019 $ |
|
| Contract |
|
| Non-Cash |
|
| May 31, 2018 $ |
| ||||||
Management, consulting and accounting services: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| ||||||
C.A.B Financial Services Ltd. (“CAB”)(1)(2) |
|
| 157,255 |
|
|
| - |
|
|
| 157,255 |
|
|
| 108,000 |
|
|
| 1,002,705 |
|
|
| 1,110,705 |
|
M&E Services Ltd. (“M&E”)(1) |
|
| 83,110 |
|
|
| - |
|
|
| 83,110 |
|
|
| 58,140 |
|
|
| 501,101 |
|
|
| 559,241 |
|
Docherty Management Limited (“Docherty Management”)(1) |
|
| 139,021 |
|
|
| - |
|
|
| 139,021 |
|
|
| 106,067 |
|
|
| 968,329 |
|
|
| 1,074,396 |
|
Company controlled by a director Consulting |
|
| - |
|
|
| - |
|
|
| - |
|
|
| 12,000 |
|
|
| 57,395 |
|
|
| 69,395 |
|
Board of Director Fees |
|
| 18,553 |
|
|
| 225,436 |
|
|
| 243,989 |
|
|
| - |
|
|
| 57,395 |
|
|
| 57,395 |
|
|
|
| 397,939 |
|
|
| 225,436 |
|
|
| 623,375 |
|
|
| 284,207 |
|
|
| 2,586,925 |
|
|
| 2,871,132 |
|
(1) CAB is owned by the CEO of the Company, M&E is owned by the CFO of the Company, and Docherty Management is owned by the President of the Company.
Due to related parties:
As at May 31, 2019, $20,995 (August 31, 2018 - $7,855) was payable to related parties, which are recorded at the exchange amount established and agreed to between the related parties.
16. Segment Information
The Company’s operations involve the development and usage, including licensing, of its proprietary nutrient infusion Technology. Lexaria is centrally managed and its chief operating decision makers, being the President and the CEO, use the consolidated and other financial information supplemented by revenue information by category of alternative health consumer products and technology licensing to make operational decisions and to assess the performance of the Company. The Company has identified two reportable operating segments: Intellectual Property Licensing and Consumer Products. Licensing revenues are significantly concentrated on three licensees.
|
| IP Licensing |
|
| Consumer |
|
| Corporate |
|
| Consolidated Total |
| ||||
External Revenue |
|
| 90,000 |
|
|
| 7,489 |
|
|
| - |
|
|
| 97,489 |
|
CoGS |
|
| - |
|
|
| (7,944 | ) |
|
| - |
|
|
| (7,944 | ) |
Operating Expenses |
|
| (1,033,392 | ) |
|
| (395,221 | ) |
|
| (1,703,370 | ) |
|
| (3,131,983 | ) |
Segment Loss |
|
| (943,392 | ) |
|
| (395,576 | ) |
|
| (1,703,370 | ) |
|
| (3,042,438 | ) |
Total Assets |
|
| 635,590 |
|
|
| 188,275 |
|
|
| 2,633,233 |
|
|
| 3,457,098 |
|
Page 17 of 49 |
17 |
Table of Contents |
17. Commitments, Significant Contracts and Contingencies
As at May 31, 2019, the Company is party to the following contractual commitments:
Party | Monthly Commitment |
| Expiry Date | ||
C.A.B Financial Services (6) |
| CAD $29,167 |
| January 1, 2022 |
|
Docherty Management Ltd. (6) |
| CAD $25,000 |
| January 1, 2022 |
|
M&E Services Ltd. (1)(2) |
| CAD $12,000 |
| June 1, 2021 |
|
Corporate Development |
| CAD $1,000 |
| Month to Month |
|
Corporate Development |
| CAD $8,000 |
| Month to Month |
|
Investor relations and communications – Alex Blanchard Capital(1) |
| CAD $7,500 |
| Month to Month |
|
Office Management(3)(4) |
| CAD $6,500 |
| December 1, 2019 |
|
Research & Development |
| CAD $3,854 |
| Month to Month |
|
Office Rent(5) |
| CAD $4,823 |
| November 15, 2023 |
|
Revenue Incentive Milestones
(1) 100,000 common shares issuable upon the Company achieving non-refundable revenues of $200,000 to any single customer in any consecutive 60-day period for the first 12 months of the contract, plus a further 50,000 common shares issuable upon achieving non-refundable revenues of $200,000 to any single customer in any consecutive 60-day period, during the 13th - 24th months of the contract. If the Company achieves non-refundable revenues of $500,000 in any fiscal quarter, a further 200,000 common shares may be issuable during the first 12 months of the contract and 100,000 common shares during the 13th - 24th months of the contract.
Intellectual Property Milestones
(2) During the term of the agreement, for each provisional patent application substantively devised and successfully created, written, and filed with the U.S. Patent Office for the Company’s Technology, 250,000 restricted common shares of the Company will be issuable.
Corporate Development Milestones
(3) For new customers sourced by a Consultant for the first 12 months of the contract; for combined Lexaria Energy and ViPova products and including all combined sales efforts and/or technology licensing revenues, achieving non-refundable revenues of $200,000 to any single customer in any consecutive 60-day period would result in a restricted common share award of 100,000 Company shares (not achieved); and, during the 13th - 24th months of the contract; a restricted common share award of 50,000 Company shares may be achieved; this clause is limited to one payment per customer during the 12-month period, but payable on each customer that meets these sales/licensing thresholds.
(4) For new customers sourced by a Consultant for the first 12 months of the contract; for combined Lexaria Energy and ViPova products and including all combined sales efforts and/or technology licensing revenues, achieving non-refundable revenues of $500,000 in any fiscal quarter would result in a restricted common share award of 200,000 Company shares (not achieved); and, during the 13th - 24th months of the contract; for combined Lexaria Energy and ViPova products and including all sales efforts, achieving non-refundable revenues of $500,000 in any fiscal quarter would result in a restricted common share award of 100,000 Company shares; this clause is limited to one payment per fiscal quarter.
Page 18 of 49 |
18 |
Office Management Milestones
(3) Until December 1, 2018 for combined Lexaria Energy and ViPova products and including all combined sales efforts and/or technology licensing revenues, achieving nonrefundable revenues of $200,000 would result in a restricted common share award of 75,000 Company shares; and from December 2, 2018, until December 1, 2019 for combined Lexaria Energy and ViPova products and including all sales efforts, achieving nonrefundable revenues of $200,000 would result in a restricted common share award of 40,000 Company shares; this clause limited to one payment per customer during the 24 month period, but payable on each customer that meets these sales/licensing thresholds;
(4) Until December 1, 2018 for combined Lexaria Energy and ViPova products and including all combined sales efforts and/or technology licensing revenues, achieving nonrefundable revenues of $500,000 in any fiscal quarter would result in a restricted common share award of 150,000 Company shares; and, from December 2, 2018, until December 1, 2019 for combined Lexaria Energy and ViPova products and including all sales efforts, achieving nonrefundable revenues of $500,000 in any fiscal quarter would result in a restricted common share award of 80,000 Company shares; this clause limited to one payment per fiscal quarter.
Corporate Offices
(5) Corporate office and R&D lab space leased in Kelowna, British Columbia, Canada until November 15, 2023 with an option to extend an additional five years. Base rent is CAN$12.56 per square foot until November 14, 2019, CAN$12.86 per square foot until November 14, 2021 and CAN $13.21 per square foot until November 14, 2023 plus common area maintenance and taxes.
Performance Incentives
(6)A performance bonus equal to 50% of the annual compensation may be payable upon the completion of certain performance criteria as determined by the board of directors of Lexaria. Compensation equal to 2% of the consideration received by the Company from the sale of a subsidiary, excluding certain circumstances. Certain compensation to be paid upon a change of control excluding certain circumstances and participation in the Company’s approved stock option plans.
18. Prepaid Expenses
Prepaid expenses consist of the following:
|
| May 31 2019 $ |
|
| August 31 2018 $ |
| ||
Advertising & Conferences |
|
| 63,673 |
|
|
| 137,654 |
|
Consulting Fees |
|
| - |
|
|
| 4,555 |
|
Office & Insurance |
|
| 40,260 |
|
|
| 21,533 |
|
Legal Fees |
|
| 18,875 |
|
|
| 29,990 |
|
|
|
| 122,808 |
|
|
| 193,732 |
|
Page 19 of 49 |
19 |
Table of Contents |
19. Marketable Securities
The components of Marketable Securities were as follows:
|
| Cost Basis $ |
|
| Unrealized Gains |
|
| Unrealized Losses $ |
|
| Total |
| ||||
August 31, 2018 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Common Stock |
|
| 25,000 |
|
|
| - |
|
|
| (14,849 | ) |
|
| 10,151 |
|
Total |
|
| 25,000 |
|
|
| - |
|
|
| (14,849 | ) |
|
| 10,151 |
|
May 31, 2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
| 81,250 |
|
|
| 9,335 |
|
|
| (15,745 | ) |
|
| 74,840 |
|
Total |
|
| 81,250 |
|
|
| 9,335 |
|
|
| (15,745 | ) |
|
| 74,840 |
|
Unrealized losses from common stock are due to market price movements. Management does not believe any remaining unrealized losses represent other-than-temporary impairments based on our evaluation of available evidence.
20. Subsequent Events
a) Subsequent to May 31, 2019 Lexaria terminated its licensing agreement with Biolog Inc. resulting in a $75,000 loss on accounts receivables.
b) Subsequent to May 31, 2019 200,000 warrants were exercised at $0.295 for $59,000.
Page 20 of 49 |
20 |
Table of Contents |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements
This quarterly report contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statements contained herein that are not statements of historical fact may be forward-looking statements. These statements relate to future events or our future financial performance. Any forward-looking statements are based on our present beliefs and assumptions as well as the information currently available to us. In some cases, you can identify forward-looking statements by terminology such as "may", “will”, "should", “could”, “targets”, “goal”, "expects", "plans", "anticipates", "believes", "estimates", "predicts", "potential" or "continue" or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled "Risk Factors" set forth in Item 1(A) in our annual report on Form 10-K, as filed with the Securities and Exchange Commission on November 14, 2018, that may cause our or our industry's actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We caution you not to place undue reliance on any forward-looking statements as they speak only as of the date on which such statements were made, and we undertake no obligation to update any forward-looking statement or to reflect the occurrence of an unanticipated event. New factors may emerge and it is not possible to predict all factors that may affect our business and prospects. Further, management cannot assess the impact of each factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
Our unaudited interim consolidated financial statements are stated in United States Dollars and are prepared in accordance with United States Generally Accepted Accounting Principles (US GAAP). The following discussion should be read in conjunction with our financial statements and the related notes that appear elsewhere in this quarterly report.
In this quarterly report, unless otherwise specified, all dollar amounts are expressed in United States dollars. All references to "C$" or "CDN$" refer to Canadian dollars and all references to "common shares" and "shares" refer to the common shares in our capital stock, unless otherwise indicated.
As used in this quarterly report, the terms "Lexaria" "we", "us", "our" and "Company" mean Company and/or our subsidiaries, unless otherwise indicated.
General and Historical Overview of Our Business
The Company was formed on December 9, 2004 under the laws of the State of Nevada as an independent oil and gas company engaged in the exploration, development and acquisition of oil and gas properties in the United States and Canada. In March of 2014, the Company began its entry into the bioscience and alternative health and wellness business and discontinued its involvement in the oil and gas business in November 2014. In May 2016, the Company also commenced out-licensing its patented DehydraTECH™ technology (the “Technology”) for improved delivery of bioactive compounds that promotes healthy ingestion methods, lower overall dosing and higher effectiveness in active molecule delivery. The Company has its office in Kelowna, BC, Canada.
Effective at the opening of trading on October 28, 2009, our shares of common stock began trading on the Canadian Securities Exchange (formerly, Canadian National Stock Exchange) under the trading symbol “LXX”.
Our common stock is quoted on the OTCQX under the symbol "LXRP" and on the Canadian Securities Exchange under the symbol “LXX”.
Page 21 of 49 |
21 |
Table of Contents |
In 2014, the Company submitted an application to enter the legal medical marijuana business in Canada and also launched a hemp oil-based food supplement company in the USA.
The Company entered into a joint venture agreement with Enertopia Corp for a prospective medical marijuana business under the Canadian Marijuana for Medical Purposes Regulations (“MMPR”) for a 49% net ownership interest in the business (Enertopia 51%) utilizing an identified location in Burlington, Ontario (the “Burlington Joint Venture”).
On June 26, 2015, we entered into a definitive agreement with Enertopia Corp. and Shaxon Enterprises Ltd. to sell our 49% interest in the Burlington Joint Venture and the MMPR application number 10MMPR0610. Pursuant to the sale terms of the agreement, the joint venture received a non-refundable $10,000 deposit and is entitled to receive up to $1,500,000 in milestone payments upon the Burlington facility becoming licensed under the MMPR. All payments made pursuant to the agreement would be divided 51% to Enertopia Corp. and 49% to our Company. Notwithstanding the foregoing, the Company does not expect the grant of a production license for the Burlington facility.
The Company’s food sciences activities include the development of our proprietary nutrient infusion technologies for the production of functional foods, and the production of enhanced food products under our consumer product brands, ViPova™, Lexaria Energy™, TurboCBD™ and ChrgD+™. The Company’s patented lipid nutrient infusion DehydraTECH™ technology is believed to improve taste, rapidity and delivery of bioactive compounds that include cannabinoids, vitamins, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), nicotine and other molecules compared to what is possible without lipophilic enhancement technology. This can allow for lower overall dosing requirements and/or higher effectiveness in active molecule delivery.
We began filing patent applications on our intellectual property during 2015 through the US Patent Office (USPTO), and also internationally under the Patent Cooperation Treaty (PCT). We were granted our first patent in October of 2016 and to date have been granted six patents through the USPTO and five in Australia.
Lexaria hopes to reduce other common but less healthy administration methods, such as smoking, as it embraces the benefits of its technology for public health. The Company is aggressively pursuing patent protection in national jurisdictions around the world. The Company currently has more than 50 patent applications pending worldwide and, due to the complexity of pursuing patent protection, the quantity of patent applications will vary continuously as each application advances or stalls. Lexaria is also filing new patent applications for novel new discoveries that arise from the Company’s R&D programs and, due to the inherent unpredictability of scientific discovery, it is not possible to predict if or how often such new applications might be filed.
As at May 31, 2019, we have identified two reportable operating segments: Intellectual Property Licensing and Consumer Products.
We maintain our registered agent's office and our U.S. business office at Nevada Agency and Transfer Company, 50 West Liberty, Suite 880, Reno, Nevada 89501. Our telephone number is (755) 322-0626.
The address of our principal executive office is Unit 100–740 McCurdy Road, Kelowna BC V1X 2P7. We have administrative functions located in Phoenix, Arizona. Our main corporate website is located at www.lexariabioscience.com.
Our common stock is quoted on the OTCQX under the symbol "LXRP" and on the Canadian Securities Exchange under the symbol “LXX”.
Due to the implementation of British Columbia Instrument 51-509 on September 30, 2008, by the British Columbia Securities Commission, we have been deemed to be a British Columbia based reporting issuer. As such, we are required to file certain information and documents available free of charge at www.sedar.com.
Page 22 of 49 |
22 |
Table of Contents |
Our Current Business
Our company’s business plan is currently focused on the development of strategic partnerships with licensees for our patented Technology in exchange for up front and/or staged licensing fees over time. Secondarily and more generally, we continue to investigate national and international opportunities for development and distribution of the Company’s enhanced functional food and supplement product offerings; to investigate expansions and additions to our intellectual property portfolio; and, to search for additional opportunities in alternative health sectors. This includes the acquisition or development of intellectual property if and when we believe it is advisable to do so.
Our current patent portfolio includes patent family grants relating to: Infused Food and Beverage Compositions and Methods of Use Thereof, pertaining to Lexaria’s method of improving bioavailability and taste, and the use of DehydraTECHTM technology as a delivery platform for a wide variety of Active Pharmaceutical Ingredients (“APIs”) encompassing all cannabinoids including THC; fat soluble vitamins; non-steroidal anti-inflammatory pain medications (“NSAIDs”); and nicotine.
To date, the following patents have been awarded:
Issued Patent # |
Patent Issuance Date |
Patent Family |
US 9,474,725 B1 | 10/25/2016 | Food and Beverage Compositions Infused With
Lipophilic Active Agents and Methods of Use Thereof |
US 9,839,612 B2 | 12/12/2017 | |
US 9,972,680 B2 | 5/15/2018 | |
US 9,974,739 B2 | 5/22/2018 | |
US 10,084,044 B2 | 9/25/2018 | |
US 10,103,225 B2 | 10/16/2018 | |
AUS 2015274698 | 6/15/2017 | |
AUS 2017203054 | 8/30/2018 | |
AUS 2018202562 | 8/30/2018 | |
AUS 2018202583 | 8/30/2018 | |
AUS 2018202584 | 1/10/2019 |
We are seeking additional patent protection for what we believe to be a unique process for the nutritional delivery of certain molecules such as Cannabinoids, Nicotine, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), and Vitamins. To achieve sustainable and profitable growth, our company intends to control the timing and costs of our projects wherever possible. We have filed for patent protection of our DehydraTECH delivery technology for additional compounds such as phosphodiesterase inhibitors, human hormones such as estrogen and testosterone, and more.
During the nine-month period ended May 31, 2019, and up to the date of this report, we experienced the following significant corporate developments:
On September 7, 2018, the Company announced additions to its patent portfolio with three new Australian patents granted to Lexaria by the Australian Patent Office. The three Australian patents are projected to expire on June 10, 2035.
The US Patent & Trademark Office also issued two new Notices of Allowance for pending patent applications and the Company announced the grants on October 16, 2018. The two new patents are related to certain cannabinoid infused beverage compositions utilizing Lexaria’s proprietary DehydraTECH process. Newly granted patent numbers US 10,103,225 B2 and US 10,084,044 B2 provide protection for compositions as well as methods for making the compositions, each of which include the use of both non-psychoactive cannabinoids such as CBD and also psychoactive cannabinoids such as THC. The Company holds eleven issued patents within its first patent family, “Food and Beverage Compositions Infused With Lipophilic Active Agents and Methods of Use Thereof” that significantly strengthen Lexaria’s intellectual property claims in the US and Australia. We continue to pursue claims in corresponding pending applications within this first patent family around the world.
Page 23 of 49 |
23 |
Table of Contents |
On September 7, 2018, the Company announced the filing of a new strategic patent application. The new provisional patent application is entitled “Lipophilic Active Agent Infused Tobacco Leaves and/or Tobacco Materials and Methods of Use Thereof”. This application represents Lexaria’s tenth patent family and expands the applicability of the already-patented DehydraTECHTM process to impart benefits to tobacco leaves that may be utilized to deliver compounds that may or may not include nicotine.
Lexaria also announced it cancelled the contract announced on April 25, 2018 with GP Holdings LLC due to ongoing delays and non-performance.
On October 10, 2018, the Company announced it has completed the creation of four wholly-owned subsidiary companies. This new corporate structure more suitably reflects the distinct customer bases and business applications for each subsidiary, thereby allowing the Company to focus its future research and consider financing structures and industry partnerships specifically optimized to each.
· | Lexaria CanPharm Corp., a Canadian company focused on providing DehydraTECHTM technology and other enhancements to the global cannabis industry. | |
· | Lexaria Nicotine Corp., a US company with a global license to provide DehydraTECH technology to the global nicotine and tobacco industries. | |
· | Lexaria Hemp Corp., a US company globally licensed to provide DehydraTECH to the rapidly growing hemp-based foods and supplements industries. | |
· | Lexaria Pharmaceutical Corp., a US company globally empowered to license DehydraTECH to the large and diverse pharmaceutical sectors. |
On October 31, 2018, the Company closed a non-brokered private placement for gross proceeds of $1,515,440 (the “Offering”). The Offering consisted of 947,150 units (each, a “Unit”) at an issue price of $1.60 per Unit. Each Unit consists of one common share of the Company (a “Share”) and one common share purchase warrant (each, a “Warrant”). Each Warrant entitles the holder to acquire one common share of the Company at a price of $2.25 per common share for a period of 24 months following the closing of the Offering. Finder’s fees of $45,080 and 28,175 finder’s warrants were paid on a portion of the proceeds raised, with each finder’s warrant having exercise terms identical to the Warrants issued. The Warrants were valued at $16,095, which were recorded as a share issue cost within additional paid in capital for a net effect of $Nil.
On November 13, 2018, the Company announced the launch of ChrgD+, a water-soluble, ready-mix hemp supplement powder packet formulation designed to be added to any drink. Lexaria engaged Cultivating Wellness Inc., a California-based brand development and distribution company, to create the ChrgD+ premium brand. Cultivating Wellness’ distribution network reaches tens of thousands of retail buyers in c-stores, grocery chains, specialty retail, and national accounts.
On November 26, 2018, the Company announced it submitted a research application under Health Canada’s Cannabis Tracking and Licensing System for the operation of a Kelowna-based R&D laboratory within Lexaria’s new head office. The laboratory will enhance Lexaria’s ability to formulate for analytical purposes, various products that may contain cannabinoids or other controlled substances. Lexaria expects to work on cannabinoid related formulations as soon as the lab receives its research license to do so. Experimental work on nicotine formulations, nonsteroidal anti-inflammatory drugs, vitamins and other bioactive compounds of interest will also begin soon after completion of lab construction. Bringing this work in-house is expected to enable the Company to expand its work schedules while reducing costs and development timelines. Lexaria also appointed Dr. Ed Ergenzinger to its executive team as Chief Legal Officer and Senior Vice President of Innovation for the Company. Dr. Ergenzinger is a U.S. licensed patent attorney who also holds a doctorate in Neuroscience (with concentrations in Pharmacology and Physiology) and is an Adjunct Professor of Law.
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On December 7, 2018, the Company announced it hired additional personnel including a new corporate controller; head of legal division and other office staff. As a result of the positions created, Lexaria issued 240,000 stock options with an exercise price of $1.06, that vest 80,000 per year until April 15, 2021 and 30,000 options with an exercise price of $1.16 that vest 10,000 per year until April 15, 2021.
On January 15, 2019, the Company announced that its wholly-owned subsidiary Lexaria Nicotine LLC (“Lexaria Nicotine”) and Altria Ventures Inc., an indirect wholly owned subsidiary of Altria Group, Inc. (“Altria”), executed definitive agreements to pursue innovation in oral, reduced risk nicotine consumer products using Lexaria’s patented DehydraTECH™ technology. Altria is funding a milestone-based research & development program (“R&D Program”) in exchange for a minority equity interest in Lexaria Nicotine and certain DehydraTECH license rights. Altria will provide initial funding of $1 million, with the option for additional funding of up to $12 million through multiple phased private financings. Altria was granted a license to use Lexaria Bioscience’s DehydraTECH technology for oral nicotine delivery forms on an exclusive basis in the United States and a non-exclusive basis elsewhere globally. Altria will pay Lexaria Nicotine a royalty on revenue generated from the sale of nicotine products containing DehydraTECH, until such time it may acquire 100% ownership in Lexaria Nicotine. Altria will initially have the right to appoint one of the seven directors on Lexaria Nicotine’s board of directors and, through the additional phased investments, may have the right to appoint up to three of the seven directors. Altria has the option to acquire 100% ownership interest in Lexaria Nicotine commensurate with then-current fair market value.
On February 21, 2019, the Company announced additional findings upon completion of further data analyses from its 2018 randomized, placebo-controlled, double-blinded European human clinical study that evaluated TurboCBD™, the Company’s proprietary, DehydraTECH™ powered, cannabidiol (“CBD”) fortified hemp-oil capsule. A single 90mg dose of TurboCBD provided evidence of lower blood pressure; higher blood flow to the brain; faster delivery onset of CBD into the bloodstream; and, larger quantities of CBD within the blood compared to a single 90mg dose of generic CBD.
Key metabolic and hemodynamic performance findings linked to bioavailability enhancements were revealed in the study, which compared a 90 mg dose of Lexaria’s TurboCBD™ to a 90 mg dose without Lexaria’s DehydraTECH™ technology (the “positive control”) as well as a placebo, as follows:
· | Analysis of mean arterial blood pressure (MAP) at peak blood levels of CBD achieved with Lexaria’s TurboCBD™ demonstrated a significant reduction in MAP compared to placebo (95% CI; p=0.027). This finding was not observed with the dose-matched positive control formulation for which there was no significant decrease in MAP compared to placebo (95% CI; p=0.625); | |
· | Cerebral perfusion was also analysed by an index of conductance in the middle cerebral artery (MCA). The findings revealed that Lexaria’s TurboCBD™ caused the greatest increase in MCA conductance relative to both the positive control formulation and placebo (95% CI; p=0.017 and P=0.002 respectively); |
Finally, over the six-hour study, analysis of the total area under the curve (AUC) demonstrated that Lexaria’s TurboCBD™ resulted in a notable trend for higher levels of CBD in the bloodstream overall than the positive control formulation with total AUC of 10,865 ± 6,322 observed with Lexaria’s formulation compared to 7,115 ± 2,978 observed with the positive control (95% CI; p=0.096). Furthermore, when normalized to body mass, the AUC at the peak CBD concentration was markedly and significantly (95% CI; p=0.02) higher with the TurboCBD™ 90 mg dose compared to the 90 mg dose positive control formulation.
On March 20, 2019, the Company announced an in vivo research program to test Lexaria designed nanotech enhancements comprised of eleven separate animal studies. Lexaria also announced that, effective March 15, 2019, it terminated the definitive license agreement entered into between Lexaria CanPharm ULC and NeutriSci International Inc. that was originally announced on February 26, 2018.
On April 9, 2019, the Company announced it negotiated 3-year term renewal management contracts with Chief Executive Officer Chris Bunka and President John Docherty. The annual compensation payable is CDN$350,000 with respect to our CEO and CDN$300,000 with respect to our President, with such contracts contemplating performance-related bonuses.
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On April 24, 2019, the Company announced that it entered a definitive 5-year agreement, via its subsidiary Lexaria Canpharm ULC, to provide Lexaria’s patented DehydraTECH technology to a private California-based company for its utilization in certain CBD-based beverages to be produced and sold in California and Nevada that may include any combination of ready-to-drink beverages such as non-alcoholic beers, wines and spirits; cold or hot coffee or teas, sports drinks and more.
On May 7, 2019, the Company announced that it entered a definitive 5-year agreement, via its subsidiary Lexaria Hemp Corp., to provide Lexaria’s patented DehydraTECH technology to a private Nevada-based company for its utilization in certain CBD-based beverages to be produced and sold across the USA that may include any combination of ready-to-drink beverages such as non-alcoholic beers, wines and spirits; cold or hot coffee or teas, sports drinks and more.
On May 15, 2019, the Company released initial results from its research program announced March 2019 demonstrating measurable quantities of cannabidiol into blood in as little as 2 minutes. In each arm of the Lexaria animal studies, 10 male Sprague-Dawley rats were administered CBD at 25mg per kg of bodyweight. Delivery of CBD into the bloodstream was monitored over a 60-minute duration. In the first animal study results, Lexaria compared its standard DehydraTECH formulation that combines cannabinoids with long-chain fatty acids (“LCFA”) using Lexaria’s patented dehydration processing technique to a concentration-matched formulation utilizing coconut oil which is a commonly used medium chain triglyceride (“MCT”) oil in the cannabis edibles industry.
· | At 2 minutes DehydraTECH’s LCFA formulation delivered measurable CBD in blood, compared to no measurable CBD in blood until 6 minutes and onwards for the MCT oil formulation. | |
· | At 15 minutes DehydraTECH’s LCFA formulation achieved a CBD blood concentration level that was 475% more than the MCT oil formulation; and, the DehydraTECH LCFA formulation CBD blood levels reached at 15 minutes were greater than the CBD blood levels reached by the MCT oil formulation at any time point during the 60-minute evaluation. | |
· | At 60 minutes DehydraTECH’s LCFA formulation achieved a CBD blood concentration level of 319% more than the MCT oil formulation. | |
· | Over the entire 60-minute study, the animals that received the standard DehydraTECH LCFA formulation achieved an average maximum CBD blood concentration level that was 334% more than the average maximum blood concentration level of the animals that received the MCT oil formulation (p<0.0021). | |
· | Over the entire 60-minute study, the area under the curve (AUC) (total quantity of CBD delivered) for the Lexaria DehydraTECH LCFA formulation was 389% more than the MCT oil formulation (p<0.0011). |
Lexaria also tested for brain tissue concentrations to quantify 8-hour CBD delivery from the DehydraTECH-enabled LCFA formulation compared to the MCT oil formulation and DehydraTECH’s LCFA formulation outperformed the MCT oil formulation by 246%.
On May 21, 2019, the Company announced a major expansion in operations by Nuka Enterprises LLC, (“Nuka”) maker of 1906 edibles over the next two years into Illinois, Ohio, Massachusetts, Michigan and other states. The comprehensive semi-exclusive agreement provides Nuka and 1906 with competitive technological advantages until 2028. A second license provides Nuka and 1906 with the immediate ability to utilize DehydraTECH technology for CBD across the US marketplace.
On May 28, 2019, the Company released additional results from its research program wherein animal testing proved that combining Lexaria’s DehydraTECH delivery technology with generic nanotech techniques delivers 1,137% more cannabidiol into animal brain tissue following oral ingestion than certain existing industry formulations. Lexaria combined its DehydraTECH delivery technology with a standard form of nanotechnology and analyzed subsequent delivery into brain tissue following oral ingestion. In each arm of the Lexaria animal studies, 10 male Sprague-Dawley rats were orally administered CBD at the rate of 25mg per kg of bodyweight. Delivery of CBD into the brain was reported 8 hours after dosing.
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· | The Lexaria DehydraTECH LCFA formulation without nanotech achieved an average brain tissue accumulation level that was 246% higher than the average for those animals that received the MCT oil formulation (p=0.0013). | |
· | The Lexaria DehydraTECH LCFA formulation with nanotech achieved an average brain tissue accumulation level that was 1,137% higher than the average for those animals that received the MCT oil formulation (p=0.0178). |
For the nine-month period ended May 31, 2019, the following table summarizes the share issuances and related values:
Type of Issuance |
| Number of |
|
| Total |
| ||
Warrant Exercise(1) |
|
| 1,426,513 |
|
| $ | 737,122 |
|
Option Exercise |
|
| 430,000 |
|
|
| 66,250 |
|
Private Placement |
|
| 947,150 |
|
|
| 1,515,440 |
|
Per Agreement(2) |
|
| 100,000 |
|
|
| 131,000 |
|
|
|
| 2,903,663 |
|
| $ | 2,449,812 |
|
(1) Includes 384,212 broker warrants exercised for gross proceeds of $144,799
(2) The Company awarded the restricted common shares as required by consulting contracts.
Food Science and Technology
Lexaria is a Biotechnology and food science company focused on developing and out-licensing its proprietary technology for improved taste, rapidity, and delivery of bioactive compounds in foods and other ingestible products Lexaria is focusing its capital and management time on its pursuit of intellectual property, technology licensing opportunities, an expanding portfolio of patent pending applications, and functional food and supplement formulations.
On November 11, 2014, our Company acquired 51% of PoViva Tea LLC and executed an operating agreement to develop a business of legally producing, manufacturing, importing/exporting, testing, researching and developing, a line of hemp oil with cannabidiol-infused teas, drinks and foods. Lexaria oversees all aspects of the business including, but not limited to, production, product quality, licensing, testing, product legality, accounting, marketing, capital investment, capital raising, sales, branding, advertising and fulfillment. On November 2, 2017, we announced that we acquired 100% of PoViva Tea LLC.
The Company introduced an expanding variety of hemp fortified consumer food products throughout 2015 to demonstrate Lexaria’s DehydraTECHTM technology to both consumers and potential licensees. From January 2015 to December 2015, seven (7) flavors of teas; hot chocolate; coffee, and two (2) flavors of protein energy bars were introduced – all utilizing Lexaria’s patented technology DehydraTECH for the more palatable and efficient delivery of bioactive molecules infused within those food products.
In the production of the products, for each raw material to be used in ViPova™ -branded products, the Company assesses if the product inputs and the completed products comply with all applicable food and drug laws, and that the inputs and the finished products meet all applicable legal and quality standards including and as it relates to hemp oil content; THC content; molds and mildews; heavy metals; and may measure additional components.
The US Federal government, through the US Department of Health and Human Services, owns US Patent #6630507, which among other things, claims that
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“Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases. The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease and HIV dementia.”
For reference, cannabinoids are compounds that affect cannabinoid receptors located on many human cells. CB1 receptors are widely found within the human brain; and CB2 receptors are found with the human immune system and have been linked to anti-inflammatory and other responses.
Despite independent scientific findings in many locations around the world, some regulatory agencies do not officially recognize that a human endocannabinoid system exists.
Over one hundred different cannabinoids have been isolated from the cannabis plant, most of which do not have psychoactive properties. One that does have psychoactive properties is tetrahydrocannabinol (THC). Endocannabinoids are produced naturally in the human body while phytocannabinoids are produced in several plant species, most abundantly in the Cannabis plant.
Cannabidiol (“CBD”) is one of the major phytocannabinoid forms of cannabinoids and is not psychoactive, often contributing more than 35% of the extracts from the cannabis plant resin. Cannabidiol occurs naturally in other plant species beyond cannabis. For example, the most widely acknowledged alternative source of phytocannabinoid is in the better understood Echinacea species, in widespread use as a dietary supplement. Most phytocannabinoids are virtually insoluble in water but are soluble in lipids and alcohol. The World Anti Doping Agency (“WADA”) has exempted CBD from its 2018 list of banned substances.
The Alternative Health sector is large and growing. A long-term Medical Expenditure Panel Survey was conducted from 2002 until 2008 with at least 29,370 subjects asked repeatedly if they had seen any kind of health care practitioner in the previous six months. The survey recorded whether the health care provider was a “complementary and alternative medicine care professional,” including “homeopathic, naturopathic, or herbalist.”
Between 5.3% and 5.8% of the survey group at any one time reported that they had seen a complementary or alternative medicine provider. Based on the US population of ~328,000,000, this suggests between 17.4 million and 19.0 million Americans are seeking an alternative health care professional at any given time.
Meanwhile the Centers for Disease Control and Prevention, in an April 2011 NCHS Data Brief, reported that more than 50% of the population uses dietary supplements of one kind or another. Detailed findings from that report included:
· Use of dietary supplements is common among the U.S. adult population. Over 40% used supplements in 1988–1994, and over one-half in 2003–2006. · Multivitamins/multiminerals are the most commonly used dietary supplements, with approximately 40% of men and women reporting use during 2003–2006. · Use of supplemental calcium increased from 28% during 1988–1994 to 61% during 2003–2006 among women aged 60 and over.
Status of Operations; Consumer product development and sales
More than 150 million Americans drink tea every day, amounting to some 79 billion servings of tea in America every year. Our launch of ViPova™ Tea brand is meant to tap into this existing demand. Part of our corporate strategy is to build national brands through products that large groups of potential customers are already familiar and comfortable with.
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PoViva Tea, LLC (now Poviva Corp.). has filed multiple patents pending and has received several granted patents to bind active hemp oil ingredients with a lipid, potentially allowing for more efficient and comforting delivery of the CBD.
Lexaria began producing cash flows from its products in January 2015 focusing on the immediate opportunities in the hemp-oil-sectors that are federally legal. Cannabinoids have been found by many researchers to have antioxidant properties and Lexaria plans to use the patented DehydraTECH process to infuse hemp oils into a number of popular food and beverages.
Lexaria has launched a line of premium products, always relying on our DehydraTECH patented infusion process, to bring hemp oil into the mainstream. Because hemp oil does not have psychoactive properties we expect our products to appeal to the widest possible customer base. To date we have focused our sales efforts across the continental USA. Some studies have found that 3% of the Canadian population regularly consumes hemp food products, while 1% of the American population regularly consumes hemp food products. We believe the consumption of hemp-based food products offers exceptional growth possibilities.
According to Nutrition Business Journal, the Organic Food sector was a $246 billion industry in the USA during 2014, while Dietary Supplements was a $34.6 billion industry. According to Arcview, Legal Cannabis was a $4.7 billion US industry in 2015 and expected to grow to over a $20 billion sector before 2025 but is clearly a much smaller industry sector than the more established food sectors. Lexaria has not yet determined whether our hemp oil-infused products will be accepted into any or all three of these particular sectors.
Lexaria has a main corporate website (www.lexariabioscience.com) as well as smaller e-commerce focused websites devoted to consumer products. The majority of product sales have taken place through the e-commerce websites. A contracted national distribution center ensures rapid and accurate fulfillment of all orders. A 1-800 ordering center has also been placed into operation.
On June 11, 2015, Lexaria initiated the simultaneous filing of a U.S. utility patent application and an International patent application under the Patent Cooperation Treaty (PCT) procedure, both through the U.S. Patent and Trademark Office (“USPTO”). These applications follow the Company’s 2014 and 2015 family of provisional patent application filings in the U.S. and serve two additional broad purposes:
1) | Lexaria is seeking protection of its intellectual property under international treaties. To this end Lexaria has filed for PCT patent application protection. There are 148 countries that are signatories to the Patent Cooperation Treaty, including such major markets as Canada, China, India, much of Europe and the Middle East, the United Kingdom and Japan among others. | |
2) | Lexaria believes its lipid infusion technology has applications beyond the delivery of just cannabinoids. Based on further formulation testing, Lexaria has included additional lipophilic molecules that may be delivered via food and beverage formats utilizing its technology, widely encompassing three major new market opportunities for the Company: Nicotine; Nonsteroidal Anti-Inflammatories (NSAIDs); and Vitamins. |
In December 2015, the Company filed two further provisional patent applications in the U.S. These new applications served to further broaden the variety and applicability of base compounds that can be used when formulating the Company’s lipid based technology. The first of these applications identify compounds like edible starches (e.g., tapioca starch) that are commonly used in food products today and could, therefore, serve as a base for formulating and incorporating the Company’s Technology into a wide variety of every day food products. The second of these applications identify emulsifier compounds like Gum Arabic that are commonly used in beverage products today in order to facilitate similar flexibility for formulating the Company’s Technology in every day, shelf-stable beverages.
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On October 26, 2016, the USPTO issued U.S Patent No. 9474725, Cannabinoid Infused Food and Beverage Compositions and Methods of Use Thereof, pertaining to our method of improving bioavailability and taste of certain cannabinoid lipophilic active agents in food products. This is the Company’s first patent granted and has a publish date of October 27, 2016 (June 15 2017 in Australia No. 2015274698) and protects our technology for twenty years. On December 12, 2017, the USPTO granted patent number US 9,839,612 B2 for the use of DehydraTECHTM technology as a delivery platform. On May 22, 2018 patent US 9,974,739 B2, “Food and Beverage Compositions Infused With Lipophilic Active Agents and Methods of Use Thereof” was granted providing for “composition of matter” claims that protect the specific combination of substances which enable improved taste and bioabsorption properties of its DehydraTECH™ technology for the delivery of cannabinoids. On May 15, 2018 patent US 9,972,680 B2, “Food and Beverage Compositions Infused With Lipophilic Active Agents and Methods of Use Thereof” was granted providing claims that protect processes for making specific compositions of matter for enhanced cannabinoid delivery utilizing its DehydraTECH™ technology. On August 31, 2018 Australian patents 2017203054, 2018202562, and 2018202583 were granted. On September 25, 2018 the USPTO granted US 10,084,044 B2 and on October16, 2018 US 10,103,225 B2 within the same patent family.
The Company does not know and cannot know whether these strategies will be successful, or if successful, how long it will take to gain consumer acceptance and customer loyalty. It can be a challenge to be successful by introducing new consumer products to a competitive retail marketplace, and we can offer no assurances that our products will be a commercial success.
International Patent Protection
When Lexaria first began examining the legal medical cannabis market in 2013, and entered the market in 2014, the Company believed it could make an impact in perhaps both the Canadian and U.S. marketplaces. Our pursuit and development of technology has expanded our potential area of impact, both geographically and by sector. Because of the applicability of our technology to markets outside of the legal cannabis sector, we have taken the necessary steps to protect that intellectual property within larger global markets, regardless of whether they lie within the medical cannabis sector or in other unrelated sectors.
Additional Molecules
NICOTINE. More than 99% of all nicotine that is consumed worldwide is delivered through smoking cigarettes. Approximately 6,000,000 deaths per year, worldwide, are attributed primarily to the delivery of nicotine through the act of smoking according to the Centers for Disease Control and Prevention, which also estimates that over $170 billion per year is spent just in the USA on direct medical care costs for adult smokers. 69% of U.S. adult smokers want to quit smoking and 43% of US adult smokers have attempted to quit in any twelve-month period.
Worldwide, retail cigarette sales were worth $722 billion in 2013, with over 5.7 trillion cigarettes sold to more than 1 billion smokers.
RELEVANCE: Lexaria postulates that enhanced delivery of nicotine to satisfy current demand, utilizing our patented lipid-delivery technology, in non-combusted, oral product formats, could shift demand away from smoking cigarettes and vaping e-cigarettes. Since most of the adverse health outcomes of nicotine consumption are associated with today's inhaled delivery methods and only to a lesser degree to the actual consumption of nicotine, there could be a vast positive community health outcome through the reduction in smoking and vaping tobacco products. Additional research and regulatory compliant investigations would need to be conducted before otherwise healthy oral product formats containing DehydraTECH-enabled nicotine could be introduced. Nicotine is a named molecule in the latest Lexaria patent applications.
NSAID. Non-steroidal Anti-inflammatories are the second-largest category of pain management treatment options in the world. The global pain management market was estimated at $22 billion in 2011, with $5.4 billion of this market being served by NSAID’s. The U.S. makes up over one-half of the global market. The opioids market (such as morphine) form the largest single pain management sector but are known to be associated with serious dependence and tolerance issues.
Some of the most commonly known NSAIDs are ASA (Aspirin), Ibuprofen (Advil, Motrin), and Acetaminophen (Tylenol - Acetaminophen is not accepted by all persons to be an NSAID). Although NSAIDs are generally a safe and effective treatment method for pain, they have been associated with a number of gastrointestinal problems including dyspepsia and gastric bleeding.
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RELEVANCE: Lexaria postulates that delivery of NSAIDs through a lipid-based mechanism could provide the beneficial properties of pain relief with lessened negative gastrointestinal effects, and also potentially deliver lower dosages of active ingredients with similar pain management outcomes as current pill forms at higher dosages. ASA, Piroxicam, Diclofenac, Indomethacin, Ibuprofen, and Acetaminophen are all named molecules in the latest Lexaria patent applications.
VITAMINS. The global vitamin and supplement market is worth $68 billion according to Euromonitor. The category is both broad and deep, comprised of many popular and some lesser known substances. Vitamins in general are thought to be an $8.5 billion annual market in the U.S. The U.S. is the largest single national market in the world, and China and Japan are the 2nd and 3rd largest vitamin markets.
Vitamin E is fat soluble and can be incorporated into cell membranes which can protect them from oxidative damage. Global consumption of natural source vitamin E was 10,900 metric tons in 2013 worth $611.9 million.
RELEVANCE: Lexaria postulates that delivery of fat soluble vitamins through its patented lipid-based delivery mechanism may result in less waste and lower dosages required than most current pill forms. As well, ingestion of pills is an unpleasant experience for many people so it is possible that vitamin delivery through common food groups could vastly expand market demand for this sector. Vitamin E is a named molecule in the latest Lexaria patent applications.
On August 11, 2015, Lexaria signed a license agreement with PoViva Tea LLC for $10,000, granting Lexaria a 35-year non exclusive worldwide license to unencumbered use of PoViva Tea LLC’s IP Rights, including rights of resale. This license agreement ensures Lexaria has full access to the underlying infusion technology. On January 14, 2019 this agreement was updated whereby Poviva Corp. granted Lexaria an exclusive license to the DehydraTECH™ technologies lasting the later of 25 years of the expiration date of the last of Poviva Corp.’s granted patents.
Scientific testing and validation
On August 24, 2015, the Company announced potential industry-changing achievements in enhanced gastro-intestinal absorption of cannabidiol (CBD) utilizing Lexaria’s technology. The third-party testing was conducted in two phases of in vitro tests beginning in June and completed in August, 2015.
The independent laboratory results delivered average CBD permeability of 499% of baseline permeability, compared to CBD permeability without Lexaria’s Technology. These results exceed Company expectations. This was assessed in a strictly controlled, in vitro experiment using a human intestinal tissue model. Samples of Lexaria’s commercially available CBD-fortified ViPova™ black tea were administered in the model compared with concentration-matched CBD control preparations that lacked Lexaria’s patented formulation and process enhancements. Lexaria believes that its in vitro findings provide compelling evidence of the intestinal absorption enhancing capabilities of its technology, based on which it is exploring opportunities to progress to more advanced, follow-on bioavailability testing in animals.
The tests also showed 325% of baseline gastro-intestinal permeability of CBD comparing Lexaria’s CBD-fortified ViPova™ black tea to a second control of CBD and black tea combined, without Lexaria’s patented formulation enhancements. This confirmed that the specialized processing undertaken by Lexaria during its manufacturing process together with its formulation enhancements, does indeed significantly improve absorption levels.
The bioavailability of CBD (or of THC) varies greatly by delivery method. Smoking typically delivers cannabinoids at an average bioavailability rate of 30% (Huestis (2007) Chem. Biodivers. 4:1770–1804; McGilveray (2005) Pain Res. Manag. 10 Suppl. A:15A – 22A). By comparison, orally consumed cannabis edibles typically deliver cannabinoids at an average bioavailability rate of only 5% (Karschner et al. (2011) Clin. Chem. 57:66–75).
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The Company’s present findings suggest that its technology may achieve a 5-fold improvement in cannabinoid absorption in edible form over that which can be achieved without its proprietary process and formulation enhancements. This conceptually supports that Lexaria’s Technology represents a significant breakthrough in cannabinoid delivery by approximating the high absorption levels achieved as though through administration by smoking, but without the associated negative effects on human health caused by smoking.
The tests were completed in two phases culminating with testing using simulated intestinal fluid conditions that delivered these findings. These results were stronger than earlier iterations of the tests that did not use a simulated intestinal fluid environment and contributed to Lexaria’s understanding of the mechanisms at work. For these and other reasons, Lexaria believes that bioavailability testing in animals is likely to yield even stronger absorption results in the presence of natural intestinal fluid conditions.
CBD has been repeatedly found to provide beneficial pain relieving, anti-inflammatory, anti-anxiety, neuroprotection, anti-psychotic, and anti-convulsive effects among others. Lexaria’s patented Technology could significantly reduce individual serving requirements for CBD to consumers. This could lead to reduced costs of consumption for consumers and increased profitability for Lexaria.
Lexaria believes that the same technology used to enhance the absorption of CBD in the recent laboratory tests, is applicable to THC, nicotine, NSAIDs and other lipophilic compounds that are widely used today.
During January 2015, Lexaria conducted a study of nitric oxide levels in humans, as a biomarker for absorption of cannabidiol, with the expectation that it would provide additional evidence of the efficient absorption of cannabidiol from Lexaria food products enhanced with hemp oil, by demonstrating the elevation of nitric oxide in the human body in response to product ingestion.
The study data from human subjects demonstrated significant elevation of systemic nitric oxide levels as a surrogate biomarker for cannabidiol (CBD) bioabsorption in response to ingestion of Lexaria's products. This provided clinical support for the CBD bioavailability enhancing properties of Lexaria's patented Technology, on the premise that bioavailable CBD is known to elevate levels of the endocannabinoid anandamide in the human body which, in turn, stimulates release of nitric oxide in the vascular system.
In summary, consuming Lexaria and ViPova™ food products resulted in elevated levels of nitric oxide within the body. The results of the study indicated that all Lexaria and ViPova™ food products elicited significant increases in salivary nitric oxide, achieving levels from 110 µM to as high as 220 µM in the test subjects. The beverage products generally had faster initial responses in as little as 15 minutes after product ingestion, whereas the initial responses from the protein-energy bars required 30 minutes. The faster response time with the beverage products was to be expected, given the relative ease of digesting liquids versus solids. All products sustained their maximum levels of nitric oxide detection through to the 60-minute end-points used in the study, indicating a need for additional study to determine the length of time that nitric oxide levels remain elevated following production consumption.
The study assessed six flavors of ViPova™ tea (Yunan Black, Herbal Cherry Black, Earl Grey, Herbal Bengal Chai, Herbal Masala Chai and Decaf English Breakfast), ViPova™ Columbian Supremo Coffee, ViPova™ Hot Chocolate and Lexaria Energy Foods’ Chocolate Berry Date and Cashew Berry Date protein-energy bars.
Six healthy human subjects (3 male and 3 female) between the ages of 22 and 65 years of age were recruited for the study. Subjects were screened for cardiovascular and allergic response to hemp products, were non-smokers and did not have any history of substance or alcohol abuse. One product was studied per day across all six subjects, with each subject consuming a full product serving size. Subjects were required to refrain from eating food or using vape products for at least 12 hours before test article administration on each day of the study. Nitric oxide levels in the test subjects were assessed using a commercially available, colorimetric test kit designed to quantify systemic nitric oxide via a detectable salivary marker. Immediately before test article administration each day, all subjects were required to demonstrate a negative baseline nitric oxide saliva test. Subjects were considered to have a negative test strip reading at a level of 20 µM according to the test strip scale, and positive readings anywhere above this. Subjects performed salivary nitric oxide testing at 15, 30, 45 and 60 minutes’ post-consumption of each product. All subjects remained sedentary from baseline through to the completion of testing for each product.
In August of 2018 we released results from our TurboCBD™ capsules in a randomized, placebo-controlled, double-blind European human clinical study that evaluated TurboCBD™ - a proprietary, DehydraTECH™ powered, cannabidiol (“CBD”) fortified hemp oil capsule developed by Lexaria. The degree and speed of CBD absorption into blood plasma and potential cardiovascular and cognitive performance enhancement in 12 healthy male volunteers were studied.
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Key bioavailability data highlights from the study comparing the 90 mg dose of Lexaria’s TurboCBD™ to a 90 mg dose of a positive control formulation without Lexaria’s DehydraTECH™ technology were as follows:
· 30 Minutes: CBD delivered from Lexaria’s TurboCBDTM capsules was absorbed much more effectively than from the positive control, delivering 317% more CBD to blood at the 30-minute mark of the study (i.e., 18.4 ng/mL compared to only 4.4 ng/mL on average respectively [95% CI; p=0.051]); · 60 Minutes: The TurboCBDTM capsules went on to deliver more CBD to the blood at the 60-minute mark (i.e., 38.8 ng/mL) than the positive control capsules were able to reach at any time during the 6-hour study, further demonstrating the exceptional rapidity of action and effectiveness of the TurboCBD™ capsules; · 90 Minutes: The TurboCBDTM capsules further went on to deliver significantly more CBD to the blood (86% more) than the positive control capsules at the 90-minute mark (i.e., 53.0 ng/mL compared to only 28.4 ng/mL respectively [95% CI; p=0.034]); · Through to Study Completion: Lexaria’s TurboCBDTM capsules continued to deliver more CBD to blood than the positive control capsules at each subsequent time point in the study through to the 6-hour mark when the study was completed.
Additional study analysis was released in February 2019:
Key metabolic and hemodynamic performance findings linked to bioavailability enhancements were revealed in the study, which compared a 90 mg dose of Lexaria’s TurboCBD™ to a 90 mg dose without Lexaria’s DehydraTECH™ technology (the “positive control”) as well as a placebo, as follows:
· Analysis of mean arterial blood pressure (MAP) at peak blood levels of CBD achieved with Lexaria’s TurboCBD™ demonstrated a significant reduction in MAP compared to placebo (95% CI; p=0.027). This finding was not observed with the dose-matched positive control formulation for which there was no significant decrease in MAP compared to placebo (95% CI; p=0.625); · Cerebral perfusion was also analysed by an index of conductance in the middle cerebral artery (MCA). The findings revealed that Lexaria’s TurboCBD™ caused the greatest increase in MCA conductance relative to both the positive control formulation and placebo (95% CI; p=0.017 and P=0.002 respectively);
Finally, over the six-hour study, analysis of the total area under the curve (AUC) demonstrated that Lexaria’s TurboCBD™ resulted in a notable trend for higher levels of CBD in the bloodstream overall than the positive control formulation with total AUC of 10,865 ± 6,322 observed with Lexaria’s formulation compared to 7,115 ± 2,978 observed with the positive control (95% CI; p=0.096). Furthermore, when normalized to body mass, the AUC at the peak CBD concentration was markedly and significantly (95% CI; p=0.02) higher with the TurboCBD™ 90 mg dose compared to the 90 mg dose positive control formulation.
These results corroborate and confirm other in vitro and in vivo studies that have evaluated Lexaria’s DehydraTECHTM technology. Although this study evaluated absorption only of CBD and its metabolites, Lexaria believes nearly identical bioavailability enhancement results would be achieved with other cannabinoids.
During March of 2019 we also launched an in vivo research program to test Lexaria designed nanotech enhancements comprised of eleven separate animal studies and released initial results during May 2019 demonstrating measurable quantities of cannabidiol into blood in as little as 2 minutes. In each arm of the animal studies, 10 male Sprague-Dawley rats were administered CBD at 25mg per kg of bodyweight. Delivery of CBD into the bloodstream was monitored over a 60-minute duration. In the first animal study results, Lexaria compared its standard DehydraTECH formulation that combines cannabinoids with long-chain fatty acids (“LCFA”) using Lexaria’s patented dehydration processing technique to a concentration-matched formulation utilizing coconut oil which is a commonly used medium chain triglyceride (“MCT”) oil in the cannabis edibles industry.
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· At 2 minutes DehydraTECH’s LCFA formulation delivered measurable CBD in blood, compared to no measurable CBD in blood until 6 minutes and onwards for the MCT oil formulation. · At 15 minutes DehydraTECH’s LCFA formulation achieved a CBD blood concentration level that was 475% more than the MCT oil formulation; and, the DehydraTECH LCFA formulation CBD blood levels reached at 15 minutes were greater than the CBD blood levels reached by the MCT oil formulation at any time point during the 60-minute evaluation. · At 60 minutes DehydraTECH’s LCFA formulation achieved a CBD blood concentration level of 319% more than the MCT oil formulation. · Over the entire 60-minute study, the animals that received the standard DehydraTECH LCFA formulation achieved an average maximum CBD blood concentration level that was 334% more than the average maximum blood concentration level of the animals that received the MCT oil formulation (p<0.0021). · Over the entire 60-minute study, the area under the curve (AUC) (total quantity of CBD delivered) for the Lexaria DehydraTECH LCFA formulation was 389% more than the MCT oil formulation (p<0.0011).
Lexaria also tested for brain tissue concentrations to quantify 8-hour CBD delivery from the DehydraTECH-enabled LCFA formulation compared to the MCT oil formulation and DehydraTECH’s LCFA formulation outperformed the MCT oil formulation by 246%.
The Company released additional results from its March 2019 research program wherein animal testing proved that combining Lexaria’s DehydraTECH delivery technology with generic nanotech techniques delivers 1,137% more cannabidiol into animal brain tissue following oral ingestion than certain existing industry formulations. Lexaria combined its DehydraTECH delivery technology with a standard form of nanotechnology and analyzed subsequent delivery into brain tissue following oral ingestion. Delivery of CBD into the brain was reported 8 hours after dosing.
· | The Lexaria DehydraTECH LCFA formulation without nanotech achieved an average brain tissue accumulation level that was 246% higher than the average for those animals that received the MCT oil formulation (p=0.0013). | |
· | The Lexaria DehydraTECH LCFA formulation with nanotech achieved an average brain tissue accumulation level that was 1,137% higher than the average for those animals that received the MCT oil formulation (p=0.0178). |
We have also completed our first study evaluating DehydraTECHTM used in a topical cream formulation for absorption of CBD through human skin. Results proved significant increases in both speed and quantity of CBD absorption through skin when compared to control formulations. The absorption study was performed on human skin at a California-based laboratory that specializes in Franz diffusion cell skin permeability testing. Lexaria’s DehydraTECHTM technology was used together with a sophisticated oil-in-water emulsion formulation design and compared to a series of matching oil-in-water emulsion formulations prepared with the same CBD inputs, with and without the DehydraTECHTM technology and with and without two leading skin penetration enhancers currently used in the skin products industry. Several factors were measured, including the time required to detect CBD skin penetration and quantity, and peak amounts of CBD absorbed into and through the skin, at multiple testing intervals over a 48-hour duration.
Lexaria’s DehydraTECHTM-enabled topical formulation, absent either of the commercial penetration enhancers, was the fastest acting for absorption into the epidermis, dermis or through the skin into the systemic fraction representing permeation into the underlying circulatory system. Lexaria’s DehydraTECHTM-enabled product also had no odour even without the use of perfumes, contrary to other cannabinoid industry products that can be quite strongly odoriferous without the use of masking perfumes.
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Furthermore, Lexaria’s DehydraTECHTM-enabled topical formulation without the addition of either of the commercial penetration enhancers, demonstrated the highest overall average quantity of CBD delivered through the skin and into the representative systemic fraction of all the formulations tested, with as much as a 225% increase in CBD permeability when compared to the highest performing commercial penetration enhancer formulation assessed and almost a 1,900% increase in CBD permeability when compared to a control formulation that was devoid of both the DehydraTECHTM technology or any commercial penetration enhancers. The commercial skin penetration enhancers only demonstrated performance that was on par or superior to the DehydraTECHTM-enabled formulations tested in so far as total CBD absorption into the shallow epidermis or dermis was concerned.
We have also completed our first ingestible nicotine in vivo (animal) absorption study. Lexaria is pursuing the use of its patented DehydraTECHTM technology as a possible new nicotine delivery method, an edible dose absorbed through the gastrointestinal tract, with potential both as a nicotine replacement therapy as well as an alternative product format for regular tobacco users.
DehydraTECHTM delivered the following major nicotine absorption performance improvements: 1,160% faster delivery of equivalent peak quantities of nicotine to the bloodstream than achieved with controls (within 15 min vs. 2.9 hours), 148% gain in the quantity of peak nicotine delivery to the bloodstream relative to controls, 560% higher brain levels of nicotine where nicotine effects are focused, compared to controls, Lower urine levels of nicotine excreted than controls, for enhanced nicotine activity and bioavailability over the course of the study, lower quantities of key liver metabolites in the bloodstream than controls as hypothesized, suggesting bypass of first pass liver metabolism.
Study Design Parameters:
The study was designed to principally assess the relative ingestible nicotine absorption performance of DehydraTECHTM-powered formulations compared to concentration-matched control formulations that lacked any form of delivery enabling technology in rats. Nicotine was administered in a nicotine polacrilex derivative format as is widely commercialized today in nicotine replacement therapy products such as chewing gums. Twelve male rats were divided into four groups of three, such that DehydraTECHTM and control formulations were each tested at a 1 mg/Kg and 10 mg/Kg dosage level. Formulations were administered orally and all rats were cannulated for blood collection at multiple intervals over an 8 hour duration post-dosing with the first data collection at the 15-minute mark. Urine and feces were also collected for up to a 24-hour duration post-dosing, and essential organ tissue samples were also collected for examination after the study. All samples were subjected to analytical testing in order to quantify the levels of nicotine therein, as well as the levels of three major liver metabolites thereof, hydroxycotinine, nicotine N’-oxide and cotinine, in order to assess the relative metabolite levels absorbed by the different formulations. Lexaria’s hypothesis was tested to prove that its DehydraTECHTM technology would influence more rapid and complete intestinal bioabsorption of nicotine lymphatically with less metabolic degradation by the liver. All animals were also assessed for general tolerability of the administered formulations. The study was conducted at the same independent laboratory in Philadelphia where the Company completed its initial cannabidiol absorption study in 2015.
Results & Observations:
The Lexaria formulations generally achieved faster absorption, higher peak absorption and higher overall quantities of nicotine, on average, in the blood than the concentration-matched control formulations at both the 1mg and 10 mg/Kg doses tested. Furthermore, as previously reported, there were no obvious signs of gastrointestinal distress such as vomiting or diarrhea indicating that the animals appeared to tolerate the treatment well.
Nicotine blood levels were evaluated multiple times over a period of 8 hours after dosing. In the 10mg/Kg dosing arm, the control formulation required nearly 3 hours to reach similar levels of blood absorption that the Lexaria formulation reached in only 15 minutes. Furthermore, the Lexaria formulation went on thereafter to demonstrate peak plasma levels that were 148% of those achieved by the control formulation. If replicated in human studies, these findings are suggestive that Lexaria’s technology could prove more effective in elevating blood nicotine levels through edible formats much more quickly and substantially than previously theorized, potentially making ingestible nicotine preparations a viable alternative to today’s available product formats while also leading to a more rapid nicotine craving satiation.
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Analysis of the liver metabolites revealed, as expected, that overall levels in the blood of two of the three metabolites studied were higher in the control group than in the Lexaria formulation group at the 10 mg/Kg dose. This result was especially pronounced in the 45-minute to 2-hour time interval post-dosing which is consistent with the expected timing of release of metabolites in higher quantity into the bloodstream by the liver following normal physiological processing of ingested nicotine with the control preparation, compared to the DehydraTECHTM technology that is believed to elude first pass liver metabolism. The Lexaria formulation also demonstrated lower quantities of nicotine in the rat urine at both doses, which is consistent with the fact that the levels of nicotine in the rat blood remained higher over the duration of the study with the Lexaria formulation than with the control. The study also revealed that the Lexaria formulation at the 10 mg/Kg level achieved up to 5.6-times as much nicotine upon analysis of the rat brain tissue than was recovered with the matching control formulation. These findings together perhaps suggest prolongation of nicotine effectiveness with the Lexaria formulation which may also be beneficial in humans to control cravings over an extended time-period from a single edible nicotine dose.
In our follow-up third-party in vivo statistically significant study, including two groups of 20 animals, further defining delivery of nicotine in edible form at each of the 2, 4, 6, 8 and 10-minute intervals post-dosing, with 90.2% greater delivery than the concentration-matched control formulation by the 10-minute mark (95% CI; p=0.044), and significantly greater absorption levels than the control formulation at all subsequent time points in the study. Speed of onset is a key attribute for oral drug administration, and it is of particular importance for the consideration of non-inhalation nicotine delivery formats.
Key highlights of the follow-up study are as follows:
· | Peak Level: 79% improvement in peak blood levels (maximum concentration or “Cmax”) at 394 ng/mL using Lexaria’s DehydraTECHTM technology vs. 220 ng/mL with the control (95% CI; p=0.0257); | |
· | Total Quantity: 94% improvement in total quantity of nicotine delivered (area under the curve or “AUC”) to the blood during the 60-minute course of the study, at 266 hr•ng/mL versus 137 hr•ng/mL (95% CI; p=0.0086); | |
· | Rapidity: Lexaria’s technology delivered nicotine into the blood stream by the first time interval of blood sampling at the 2-minute mark. On average, Lexaria’s technology delivered 203 ng/mL to the blood in aggregate of the 2, 4, 6, 8, 10, 12 and 15-minute time points, compared to only 120 ng/mL in aggregate over the same period by the control, an improvement of 70% (95% CI; p=0.0004). |
In addition to the above described scientific testing and validation studies, Lexaria has also conducted various cannabinoid formulation experiments, together with potential DehydraTECH™ licensee partners, on chocolates, candies, gummies, mouth-melts, chocolate bars, protein bars, beverages such as beer, spices, tea, coffee, supplements and more over the past several years. Beverage formulations have produced cannabinoid water-based products including de-alcoholized beer that mask unwanted cannabis flavor and are fast acting. Chocolate formulations were reported as being the fastest acting, most consistent, and best-tasting products relative to comparator control formulations in approximately 70% of cases in a recent 2017 consumer study. As well, on March 22, 2016, Lexaria announced results from another chocolate formulation consumer study in which test subjects ranked those chocolates that had been created with Lexaria’s technology as the best tasting, most palatable and providing the best overall experience of the chocolates sampled. Furthermore, the test subjects in that study indicated a time of onset of the cannabis oil effects in as little as 15-20 minutes on average. The study included 12 volunteers who were all regular cannabis consumers with experience ingesting conventional edibles. All chocolates used in the study were blinded (unmarked) in order that the subjects could not discern the product formulations applied.
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Technology out-licensing
On May 14, 2016, the Company entered into a Licensing Agreement with Nuka Enterprises, LLC (“Nuka”) for a two-year period, to utilize the Company’s technology to create, test, manufacture, and sell marijuana-infused consumable and/or topical products, in the state of Colorado, with an option of extending the terms of the Licensing Agreement to Washington, Oregon, and California. On April 30, 2018, the Company announced a new 10-year renewal licensing agreement with Nuka, maker of 1906 brand cannabis chocolates and other edible products. The new agreement provides Nuka with semi-exclusive ability to utilize the DehydraTECHTM technology across the US. Nuka also acquired an option to expand its products and brand to Canada, including using Lexaria’s existing chocolate and confections contract manufacturer licensee Cannfections Group Inc. The agreement incorporates new rights in product categories in addition to the original chocolate formats, which include candies, beverages, capsules and pills, and topical creams. On May 21, 2019, we announced a major expansion in operations by Nuka over the next two years into Illinois, Ohio, Massachusetts, Michigan and other states. The comprehensive semi-exclusive agreement provides Nuka and 1906 with competitive technological advantages until 2028. A second license provides Nuka and 1906 with the immediate ability to utilize DehydraTECH technology for CBD across the US marketplace.
On January 25, 2018, the Company announced it entered a definitive technology licensing agreement with a 7-year term with Cannfections Group Inc. whereby Lexaria is providing its patented DehydraTECHTM technology to empower next-generation performance in cannabis infused chocolates and candies to be developed and sold in Canada and internationally.
On February 26, 2018 the Company announced it entered an agreement with NeutriSci International Inc. ("NeutriSci") (TSX-V: NU, OTCQB: NRXCF) such that NeutriSci now owns 100% of Ambarii Trade Corporation and Lexaria has granted to NeutriSci an Intellectual Property License and Supply Agreement for the manufacturing and sale of CBD based products. This agreement has been terminated effective March 15, 2019.
On February 27, 2018 the Company announced it entered a definitive technology licensing agreement with Los Angeles-based, privately-held Biolog, Inc. (“Biolog”) for a 5-year term whereby Lexaria provided its patented DehydraTECHTM technology to empower a unique set of next-generation food and beverage cannabis infusion products to be sold in the United States. On June 10, 2019 the Company terminated its license with Biolog Inc.
On April 25, 2018, the Company announced that it entered a definitive technology licensing agreement with GP Holdings LLC, (“GP”) whereby Lexaria provided its patented DehydraTECHTM technology for cannabis infused beverages and topical skin products in California. GP acquired a 5-year semi-exclusive right. Subsequent to year end, on September 28, 2018, the Company cancelled the contract due to ongoing delays and non-performance.
On July 31, 2018, the Company announced, and Hill Street Beverage Company Inc., (TSXV:BEER; “Hill Street”) jointly announced that they signed a Definitive Agreement to license Lexaria’s DehydraTECHTM, on a semi-exclusive basis, for a term of five (5) years, to produce a line of cannabis-infused alcohol-free beverages for Canadian distribution, following regulatory approval.
On January 15, 2019, the Company announced that its wholly-owned subsidiary Lexaria Nicotine LLC (“Lexaria Nicotine”) and Altria Ventures Inc., an indirect wholly owned subsidiary of Altria Group, Inc. (“Altria”), executed definitive agreements to pursue innovation in oral, reduced risk nicotine consumer products using Lexaria’s patented DehydraTECH™ technology. Altria was granted a license to use Lexaria Bioscience’s DehydraTECH technology for oral nicotine delivery forms on an exclusive basis in the United States and a non-exclusive basis elsewhere globally. Altria will pay Lexaria Nicotine a royalty on revenue generated from the sale of nicotine products containing DehydraTECH, until such time it may acquire 100% ownership in Lexaria Nicotine.
On April 24, 2019, the Company announced that it entered a definitive 5-year agreement, via its subsidiary Lexaria Canpharm ULC, to provide Lexaria’s patented DehydraTECH technology to a private California-based company for its utilization in certain CBD-based beverages to be produced and sold in California and Nevada that may include any combination of ready-to-drink beverages such as non-alcoholic beers, wines and spirits; cold or hot coffee or teas, sports drinks and more.
On May 7, 2019, the Company announced that it entered a definitive 5-year agreement, via its subsidiary Lexaria Hemp Corp., to provide Lexaria’s patented DehydraTECH technology to a private Nevada-based company for its utilization in certain CBD-based beverages to be produced and sold across the USA that may include any combination of ready-to-drink beverages such as non-alcoholic beers, wines and spirits; cold or hot coffee or teas, sports drinks and more.
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The continuation of our business interests in these sectors is dependent upon obtaining further financing, a successful programs of development, and, ultimately, achieving a profitable level of operations. The issuance of additional equity securities by us could result in a significant dilution in the equity interests of our current stockholders. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities and future cash commitments.
We are not yet profitable and have not yet demonstrated our ability to generate significant revenues from our business plan. We will require additional corporate funds if our existing capital is not sufficient to support the Company until potential future profitability is reached. There are no assurances that we will be able to obtain further funds required for our long-term operations. We do not expect to require additional operating capital during our fiscal 2019 year, but do expect to require capital in order to establish our own, federally licensed Canadian laboratory on-premises for our internal R&D purposes. There can be no assurance that additional financing will be available to us when needed or, if available, that it can be obtained on commercially reasonable terms. If we are not able to obtain the additional financing on a timely basis, we will be unable to conduct our operations as planned, and we will not be able to meet our other longer-term obligations as they become due. In such event, we could be forced to scale down or perhaps even cease our operations. There is uncertainty as to whether we can obtain additional long-term financing if we do in fact require it.
Our business plan anticipates that we will hire three to six employees and includes new office space that is under construction in order to facilitate a federally licensed Canadian laboratory on-premises for our internal R&D purposes. As at May 31, 2019 office spaces are primarily complete and in-use, the laboratory space is also primarily complete with final equipment design and acquisition in progress and we have hired three employees with a fourth scheduled to begin in the laboratory space during our fiscal fourth quarter. We expect to be able to utilize contracted third parties for most of our production and distribution needs, instead focusing our capital on higher value-added aspects of the business such as research and development, and scientific testing. We have no current plans to build our own production facility.
Our company relies on the business experience of our existing management, on the technical abilities of consulting experts, and on the technical and operational abilities of its operating partner companies to evaluate business opportunities.
Competition
The legal marijuana industry is comprised of several sub-sectors and is legal under different guidelines in many states though it remains illegal under most federal laws. Notwithstanding, the overall sector is generally recognized to be one of the fastest growing in the USA, with state-legal revenue of over $8 billion in 2016. Independent projections and publicized reports expect revenue of $20 billion or more in 2020, both as the sector gains in credibility and acceptance, and as more and more states legalize either medical use or adult recreational use; or both. In any fast growing industry, competition is expected to be both strong and also difficult to evaluate as to the most effective competitive threats. While we are an early adopter within the cannabinoid delivery sector, there are already reports of more than 300 public companies that have claimed to be involved in the sector in some fashion; and an unknown number of private companies. Our current strategies may prove to be ineffective as the sector grows and matures, and if so, we will have to adapt quickly to changing sectoral circumstances. Accordingly, the Company intends to aggressively pursue technology out-licensing opportunities not only within the cannabinoids sector where it is already active, but also across other sectors where its DehydraTECHTM technology is patent allowed and/or pending, including the opportunities in the vitamin and supplements sector, the pain relief sector and the nicotine products sector.
Competition in alternative health sectors and in consumer products in the USA is fierce. We expect to encounter competitive threats from existing participants in the sector and new entrants. Although PoViva Corp. has filed patent applications to protect intellectual property, there is no assurance that patents beyond those already issued will be granted nor that other firms may not file superior patents pending. Food supplements, organic foods, and health food markets are all well established and our Company will face many challenges trying to enter these markets. Lexaria is also aware of various competing technologies that exist in the marketplace that claim to also enhance the bioabsorption of cannabinoids as Lexaria has demonstrated through repeated in vitro and in vivo scientific testing with its patented DehydraTECHTM technology. By and large, these technologies are all forms of nanotechnology that generally claim to enable the formation of microencapsulated microemulsions of cannabinoid active ingredients. These technologies can enable exceptional water solubility of cannabinoid ingredients and can impart improved intestinal bioabsorption as a result.
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However, it is Lexaria’s belief that its patented DehydraTECHTM technology offers a host of benefits beyond what competing technologies can offer, including superior oral palatability, a more appealing and all-natural ingredient compositional profile from a food and beverage formulation perspective and superior scalability and cost effectiveness from a manufacturing perspective. Lexaria believes that its DehydraTECHTM technology is, therefore, significantly distinguished from competing technologies in these respects, with a view to growing the breadth and number of licensees that will adopt its technology for their product offerings going forward. Lexaria believes that these competitive advantages together with its wealth of scientific data showing noteworthy bioabsorption enhancements with its DehydraTECHTM technology constitute a compelling value proposition for its prospective licensees, and it intends to continue to pursue license arrangements not only within the cannabinoids edibles sector where it is already active, but also in the various other bioactive ingredient sectors identified in its issued and pending patent applications.
Compliance with Government Regulation
Over 30 States in the USA have passed some form of legislation related to that state’s permission to grow, cultivate, sell or use marijuana either for medical purposes or for recreational or “adult use” purposes; or both. The various state legislation is not necessarily harmonious with one another, leading to potential conflicts between state laws. It is most often not legal to transport cannabis-related products across state lines.
Lexaria does not “touch the plant” in any location within or outside of the USA. We comply with federal law that provides for certain exemptions for agricultural (industrial) hemp and certain byproducts to be manufactured and sold in the US. The DehydraTECHTM technology may have applications within the legal marijuana sector and we may seek to license that technology to companies that have met and comply with state regulations for the sale or distribution of cannabis related products in any particular jurisdiction.
Lexaria’s position is that, just as a telephone company provides communications services, and an electric company provides electrical power, our provision of technological services to a state-legal cannabis company is in compliance with laws and required regulations.
Lexaria’s patented DehydraTECHTM technology may also have application in completely separate sectors such as vitamins, non-steroidal anti-inflammatories, and nicotine. We have no products nor operations in any of these sectors today, although we have commenced formulation development for research and validation purposes in each of these areas. If we enter any of these sectors at any time, we will be exposed to and of necessity will have to comply with, all local, state and federal regulations in each of those sectors. As a result of the possibility of Lexaria being involved in a number of disparate business sectors, compliance with government regulations could require significant resources and expertise from our company.
The US Federal Government passed the 2018 Farm Bill (the “Bill”), in December of 2018, that may have significant positive impacts on industry segments that we operate and have products in and potentially change some of the regulatory compliance risks that may affect our business. The Bill includes lifting restrictions on advertising, marketing, banking and other financial services as well as allowing interstate commerce for hemp and hemp-derived cannabidiol (CBD), remove barriers for intellectual property protections under federal law such as patents and trademarks, as well as several other measures that may positively impact these industry segments overall. The impact the Bill may have on other regulatory bodies and their regulations will require ongoing monitoring to determine the outcome and timing of any revisions.
Significant Acquisitions and Dispositions
We have leased a new head-office location in Kelowna, Canada, that included the purchase and construction of office equipment, furniture, computers, and communications systems. We also constructed space for a federal licensed Canadian laboratory on-premises for our internal R&D purposes, for which a license application has been filed with Health Canada. Costs incurred to date are included in Capitalized Assets in the financial statements and notes.
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Contractors
We primarily use sub-contractors and consultants in the intellectual property development and licensing, and alternative health product sectors. We have added three employees during our second fiscal quarter and additional research personnel are anticipated during fiscal 2019 and upon license approval from Health Canada for the research lab. We primarily engage with consultants to serve our executive needs.
The Company had an agreement with CAB for a consulting fee of $144,000 per year and has negotiated a 3-year term renewal management contract with Chief Executive Officer Chris Bunka retroactively effective January 1, 2019. The annual compensation payable is CDN$350,000 per year and the following performance incentives.
Performance Incentives
| · | A performance bonus equal to 50% of the annual compensation may be payable upon the completion of certain performance criteria as determined by the board of directors of Lexaria. Compensation equal to 2% of the consideration received by the Company from the sale of a subsidiary, excluding certain circumstances. Certain compensation to be paid upon a change of control excluding certain circumstances and participation in the Company’s approved stock option plans. |
The Company appointed Mr. John Docherty as President of Lexaria effective April 15, 2015. The Company had an agreement with Docherty Management Limited, solely owned by Mr. John Docherty with compensation of CAD$180,000 plus applicable taxes per year and has negotiated a 3-year term renewal management contract CAD$300,000 per year and the following performance incentives.
| · | Performance Incentives as defined above. |
On July 1, 2018 the Company executed an updated three-year consulting contract with M&E Services Ltd. (M&E), a company wholly owned by Mr. Allan Spissinger, with monthly compensation of CAD$12,000 including an 8% annual increase superseding the previous CAD$8,000 per month contract that included 200,000 incentive stock options exercisable at $0.37. The Company may pay Mr. Spissinger a bonus from time to time, at its sole discretion. Mr. Spissinger will be entitled to receive additional common stock-based and stock option based bonuses upon achieving certain milestones during the time of his consultancy with the Company. These milestones are:
Revenue Incentive Milestones (Revenue Incentives “A”)
| · | 100,000 common shares issuable upon the Company achieving non-refundable revenues of $200,000 to any single customer in any consecutive 60-day period for the first 12 months of the contract, plus a further 50,000 common shares issuable upon achieving non-refundable revenues of $200,000 to any single customer in any consecutive 60-day period, during the 13th - 24th months of the contract. If the Company achieves non-refundable revenues of $500,000 in any fiscal quarter, a further 200,000 common shares may be issuable during the first 12 months of the contract and 100,000 common shares during the 13th - 24th months of the contract. |
On June 19, 2017, the Company executed a contract with Alex Blanchard Capital as manager for investor relations and communications. The agreement is for six months continuing month to month for CAD$7,500 per month and may be terminated thereafter with one month’s notice. Mr. Blanchard was granted 200,000 warrants exercisable at $0.29 and 300,000 stock options exercisable at $0.295 vesting 100,000 options at 1st – 3rd anniversaries of the contract provided that the contract is not terminated. Mr. Blanchard will be entitled to receive additional common stock-based and stock option based bonuses upon achieving certain milestones during the time of his consultancy with the Company. These milestones are during the first 12 months after the date of the agreement with Alex Blanchard Capital:
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| · | Revenue Incentives “A” as defined above. |
We are planning an increase in the number of personnel over the next 12 month period to enhance capacity and, subject to regulatory approval of the lab facility, for R&D purposes. We do and will continue to outsource contract employment as needed. Additional capacity may be required with product advancement or retail acceptance of our new products, we may need to retain additional personnel particularly in the fields of product manufacturing, development, sales and distribution. It is not possible to accurately project potential needs into the future based on circumstances that may or may not occur.
Research and Development
Lexaria incurred $394,091 (2018 $279,221) in research and development expenditures during the period ending May 31, 2019. Specific R&D programs are in ongoing development and will be tightly related to our financial ability to undertake each research phase for each molecule. Due to our expanding portfolio coverage, we are continuing to examine accelerated timetable options for testing, research and development.
The Company’s plans to include in vitro absorption tests of our patented technology of molecules such as: Vitamin E, Ibuprofen, and Nicotine allowed us to perform testing on Nicotine with positive results. Our plan to conduct our first ever in vivo absorption tests on CBD also yielded positive results. Ongoing testing plans are proceeding to further define molecular compatibility, absorption rates, timing and viable formats of delivery.
The Company continually focuses on new R&D programs to investigate potential additional commercial applications for its technology. These include, but are not limited to, ongoing programs to explore methods to integrate nanoemulsification chemistry techniques together with its technology, as well as ongoing programs to further enhance intestinal bioabsorption rates with its technology, as well as ongoing programs to expand the types and breadth of product form factors into which its technology can be applied. Depending on how many of these tests are undertaken, R&D budgets are expected to vary significantly, to do so. It is in our best interests to remain flexible at this early stage of our R&D efforts in order to capitalize on potential novel findings from early-stage tests and thus re-direct research into specific avenues that offer the most reward.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to stockholders.
Critical Accounting Estimates
Our consolidated financial statements and accompanying notes are prepared in accordance with generally accepted accounting principles used in the United States. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. These estimates and assumptions are affected by management's application of accounting policies. We believe that understanding the basis and nature of the estimates and assumptions involved with the following aspects of our financial statements is critical to an understanding of our financials.
Capital Assets
Capital assets are stated at cost less accumulated depreciation and depreciated using the straight-line method over their useful lives or by units of production.
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Patents
Capitalized patent costs represent legal costs incurred to establish patents. When patents reach a mature stage, any associated legal costs are comprised mostly of maintenance fees and are expensed as incurred. Capitalized patent costs are amortized on a straight-line basis over the remaining life of the patent.
Revenue Recognition
Product revenue
Revenue from the sale of alternative health products is recognized when persuasive evidence of an arrangement exists, delivery has occurred, the sales price is fixed or determinable, and collectability is reasonably assured, which typically occurs upon shipment. The Company reports its sales net of the amount of actual sales returns. Sales tax collected from customers is excluded from net sales.
Licensing revenue from Intellectual Property
We recognize revenue for License fees at a point in time following the transfer of our intellectual property, our patented lipid nutrient infusion technology DehydraTECH™ for infusing Active Pharmaceutical Ingredients, to the licensee, which typically occurs on delivery of documentation.
Usage Fees from Intellectual Property
We recognize revenue for Usage fees when usage of our DehydraTECH™ intellectual property occurs by licensees infusing and Active Pharmaceutical Ingredient into one or more of their product lines for sale.
Going Concern
We have suffered recurring losses from operations. The continuation of our Company as a going concern is dependent upon our Company attaining and maintaining profitable operations and/or raising additional capital. The financial statements do not include any adjustment relating to the recovery and classification of recorded asset amounts or the amount and classification of liabilities that might be necessary should our Company discontinue operations. The recurring losses from operations and net capital deficiency raise substantial doubt about the Company’s ability to continue as a going concern.
Recent Accounting Guidance
In January 2016, FASB issued an ASU, Subtopic 82510, to amend certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. Most prominent among the amendments is the requirement for changes in fair value of equity investments, with certain exceptions, to be recognized through profit or loss rather than other comprehensive income. The Company adopted the standard September 1, 2018. The impact was not material and the $14,247 impact on the Company’s financial statements was included in income in the current period.
In February 2016 FASB issued ASU No. 201602, Leases (Topic 842) which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation, and disclosure of leases for both lessees and the lessors. The new standard requires the lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. The classification will determine whether lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease, respectively. A lessee is also required to record a right of use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. When adopted, the Company does not expect this guidance to have a material impact on its consolidated financial statements.
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In June 2016, the FASB issued a new standard to replace the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss credit loss estimates. For trade and other receivables, loans and other financial instruments, the Company will be required to use a forward looking expected loss model rather than the incurred loss model for recognizing credit losses which reflects losses that are probable. Credit losses relating to available for sale debt securities will also be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. The new standard will be effective for Lexaria beginning September 1, 2020, with early adoption permitted. Application of the amendments is through a cumulative effect adjustment to deficit as of the effective date. The Company is currently assessing the impact of the standard on its consolidated financial statements.
In February 2018, the FASB issued ASU No. 201802, Income Statement–Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income, which allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act enacted by the U.S. federal government on December 22, 2017 (the “2017 Tax Act”). Consequently, the amendments eliminate the stranded tax effects resulting from the 2017 Tax Act and will improve the usefulness of information reported to financial statement users. The amendments in this ASU are effective for all entities for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period, (1) for public business entities for reporting periods for which financial statements have not yet been issued and (2) for all other entities for reporting periods for which financial statements have not yet been made available for issuance. The Company is currently evaluating the effect this ASU will have on its consolidated financial statements and related disclosures, but does not expect it to have a material impact on its consolidated financial statements.
In June 2018, the FASB issued ASU No. 201807, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share Based Payment Accounting. This is a simplification that involves several aspects of accounting for nonemployee share based payments resulting from expanding the scope of Topic 718 to include share based payment transactions for acquiring goods and services from nonemployees. The new standard will be effective for Lexaria for September 1, 2019. The company does not expect it to have a material impact on its consolidated financial statements.
Results of Operations – Nine Months Ended May 31, 2019 and 2018
The following summary of our results of operations should be read in conjunction with our unaudited financial statements for the period ended May 31, 2019, which are included herein.
Our operating results for the nine-months ended May 31, 2019 and 2018 and the changes between those periods for the respective items are summarized as follows:
|
| Nine Months Ended May 31 2019 $ |
|
| Nine Months May 31 2018 $ |
|
| Change Between the Periods $ |
| |||
Sales |
|
| 97,489 |
|
|
| 336,933 |
|
|
| (239,444 | ) |
Cost of Goods Sold |
|
| 7,944 |
|
|
| 22,239 |
|
|
| (14,295 | ) |
General and Administrative |
|
| 3,131,983 |
|
|
| 5,684,088 |
|
|
| (2,552,105 | ) |
Impairment of Inventory |
|
| - |
|
|
| 12,609 |
|
|
| (12,609 | ) |
Net loss |
|
| (3,042,438 | ) |
|
| (5,382,003 | ) |
|
| 2,339,565 |
|
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Our financial statements report a net loss of $3,042,438 for the nine-month period ended May 31, 2019 compared to 2018 where we incurred a net loss of $5,382,003. During the nine-month period ended May 31, 2019, our general and administrative expenses were lower compared to the nine-months ended May 31, 2018, which is a result of the decreases in consulting expenses due to lower contractual share based and share based compensation expenses but include increases in legal expenditures relating to contract negotiations and patent filings, new employees and R&D.
Revenue was primarily based on Licensing usage fees in line with contract requirements, while consumer product sales remain low due to challenges in securing expansive distribution opportunities, production challenges and payment processing changes. The Company continues to pursue more widespread distribution possibilities which have the potential to unlock more significant consumer revenues.
Results of Operations – Three Months Ended May 31, 2019 and 2018
The following summary of our results of operations should be read in conjunction with our unaudited financial statements for the period ended May 31, 2019, which are included herein.
Our operating results for the three months ended May 31, 2019 and 2018 and the changes between those periods for the respective items are summarized as follows:
|
| Three Months Ended May 31 2019 $ |
|
| Three Months Ended May 31 2018 $ |
|
| Change Between the Periods $ |
| |||
Sales |
|
| 59,931 |
|
|
| 140,340 |
|
|
| (80,409 | ) |
Cost of Goods Sold |
|
| 3,096 |
|
|
| 2,427 |
|
|
| 669 |
|
General and Administrative |
|
| 1,244,771 |
|
|
| 3,559,200 |
|
|
| (2,314,429 | ) |
Impairment of Inventory |
|
| - |
|
|
| 3,625 |
|
|
| (3,625 | ) |
Net loss |
|
| (1,187,936 | ) |
|
| (3,424,912 | ) |
|
| 2,236,976 |
|
Our financial statements report a net loss of $1,187,936 for the three-month period ended May 31, 2019 compared to 2018 where we incurred a net loss of $3,424,912. During the three-month period ended May 31, 2019, our general and administrative expenses were lower compared to the three-months ended May 31, 2018, which is a result of the decreases in consulting expenses due to lower contractual share based and share based compensation expenses but include increases in legal expenditures relating to contract negotiations and patent filings, new employees and R&D.
Revenue was primarily based on Licensing usage fees in line with contract requirements, while consumer product sales remain low due to challenges in securing expansive distribution opportunities, production challenges and payment processing changes. The Company continues to pursue more widespread distribution possibilities which have the potential to unlock more significant consumer revenues.
The trend of hemp oil fortified foods, and hemp seed products, gaining consumer acceptance continued and provides a reason to believe that sales could increase. Those trends should support higher potential consumer product sales. In addition, legislative trends in America and in many nations around the world such as Canada and the UK are supportive of additional opportunities in the hemp-based foods and supplements sector. Those trends could support higher potential consumer product sales. Release of the TurboCBDTM product was successful but sales were limited by changes to payment processing services outside of the Company’s control. The initial release of ChrgD+ was well received and we are in progress of final development and release of the online ordering portal for both retail and channel distribution, which we expect to be operational during the fourth quarter of fiscal 2019.
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For 2019 the Company expects to continue to derive the majority of its revenues from technology licensing to third parties noting that IP Territory fees are recognized when new definitive license agreements occur and IP Usage fees are dependent upon licensees opportunity to implements the technology based upon regulatory approval. Canadian regulatory approval for ingestible products is anticipated October 17, 2019, when entities are anticipated to be able to apply for permits to distribute and sell their products. At August 31, 2015 the Company had zero technology licensing agreements entered. By August 31, 2016 we had entered several LOI’s or definitive agreements related to technology out-licensing. During the period ended August 31, 2018 we entered into six new licensing agreements (although some were subsequently cancelled due to non performance) that increased our IP licensing revenue and we expect additional revenue will be generated from the licensees utilizing the technology in their processes from the usage fees as their production and sales occur. It is the Company’s view that the December 9, 2017, grant of patent US 9,839,612 B2, the grants of US 9,972,680 B2 and US 9,974,739 B2 during May 2018, the September 25, 2018 grant of US 10,084,044 B2, the October 16, 2018 grant of US 10,103,225 B2 and its expanding patent portfolio are positive steps in enabling the generation of more significant revenues. At the time of this report the Company has entered more than 10 formal letters of intent or definitive agreements and is negotiating more.
We do not expect that all of the Letters of Intent into which we enter will result in definitive agreements with paying customers and cannot predict how many will. We believe that strengthening and expanding our intellectual property portfolio and conducting supportive R&D will jointly contribute to strengthening revenue prospects.
Liquidity and Financial Condition
Working Capital |
| May 31 2019 $ |
|
| August 31 2018 $ |
| ||
Current assets |
|
| 2,607,599 |
|
|
| 2,284,051 |
|
Current liabilities |
|
| 132,293 |
|
|
| 43,640 |
|
Working capital balance (deficiency) |
|
| 2,475,306 |
|
|
| 2,240,411 |
|
The Company’s working capital balance increased during the nine months ended May 31, 2019, as a result of the completion of a private placement in October, 2018 for $1,470,310 net of fees and $1,803,373 from the exercise of options and warrants, and the agreement with Altria.
|
| Nine Months Ended |
| |||||
Cash flows |
| May 31 2019 $ |
|
| May 31 2018 $ |
| ||
Cash flows used in operating activities |
|
| (2,268,946 | ) |
|
| (1,121,192 | ) |
Cash flows used in investing activities |
|
| (736,079 | ) |
|
| (102,042 | ) |
Cash flows provided by financing activities |
|
| 3,273,683 |
|
|
| 1,007,591 |
|
Increase (decrease) in cash |
|
| 268,658 |
|
|
| (215,643 | ) |
Operating Activities
The increase in the net cash used in operating activities during the nine months ended May 31 2019, is primarily as a result of increases in legal expenses, hiring employees and reduction in revenues. Operating activities remained relatively consistent between the comparison periods with increases in advertising and promotions, investor relations, increases to ongoing legal fees for patent and trademark filings, legal fees for contract negotiations, R&D programs and employee additions.
Investing Activities
During the nine months ended May 31, 2019, the Company continued its investment in expanding its patent and trademark filings, lease-hold improvements for the new head office location with in-house Health Canada compliant research lab, and equipment purchases.
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Financing Activities
During the period ended May 31, 2019, the Company raised a total of $2,318,812 from equity issuances, relating to the private placement closed in October 2018 and the ongoing exercises of its outstanding stock options and warrants. In addition, $1,000,000 was raised relating to the research agreement and acquisition of 16.67% of Lexaria Nicotine by Altria.
Item 3. Quantitative and Qualitative Disclosure About Market Risk
Not applicable. The Company qualifies as a “Smaller Reporting Company” and, accordingly, this Item 3 and the related disclosure is not required.
Item 4. Controls and Procedures
Management’s Report on Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms, and that such information is accumulated and communicated to our management, including our president (also our principal executive officer) and our chief operating and financial officer (also our principal financial and accounting officer) to allow for timely decisions regarding required disclosure.
As of May 31, 2019, the end of our quarter covered by this report, we carried out an evaluation, under the supervision and with the participation of our president, our chief executive and chief financial officer (also our principal executive and accounting officers), of the effectiveness of the design and operation of our disclosure controls and procedures. Based on the foregoing, our president, chief executive and financial officer (also our principal executive and accounting officers) concluded that our disclosure controls and procedures were effective at a reasonable assurance level as of May 31 2019.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Responsibility, estimates and judgments by management are required to assess the expected benefits and related costs of control procedures. The objectives of internal control include providing management with reasonable, but not absolute, assurance that assets are safeguarded against loss from unauthorized use or disposition, and that transactions are executed in accordance with management’s authorization and recorded properly to permit the preparation of financial statements in conformity with accounting principles generally accepted in the United States. Our management assessed the effectiveness of our internal control over financial reporting as of May 31 2019. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control-Integrated Framework. Our management has concluded that, as of May 31, 2019, our internal control over financial reporting is effective in providing reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with US generally accepted accounting principles. Our management reviewed the results of their assessment with our Board of Directors.
Inherent limitations on effectiveness of controls
Internal control over financial reporting has inherent limitations which include but is not limited to the use of independent professionals for advice and guidance, interpretation of existing and/or changing rules and principles, segregation of management duties, scale of organization, and personnel factors. Internal control over financial reporting is a process which involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements on a timely basis, however these inherent limitations are known features of the financial reporting process and it is possible to design into the process safeguards to reduce, though not eliminate, this risk. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal controls over financial reporting that occurred during the period ended May 31 2019, that have materially or are reasonably likely to materially affect, our internal controls over financial reporting.
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We know of no other material, existing or pending legal proceedings against our company, nor are we involved as a plaintiff in any other material proceeding or pending litigation. There are no other proceedings in which any of our directors, executive officers or affiliates, or any registered or beneficial stockholder, is an adverse party or has a material interest adverse to our interest.
Much of the information included in this quarterly report includes or is based upon estimates, projections or other "forward looking statements". Such forward looking statements include any projections or estimates made by us and our management in connection with our business operations. While these forward-looking statements, and any assumptions upon which they are based, are made in good faith and reflect our current judgment regarding the direction of our business, actual results will almost always vary, sometimes materially, from any estimates, predictions, projections, assumptions or other future performance suggested herein.
The risks associated with our business, common stock and other factors were the same as those described in the consolidated financial statements for the year ended August 31, 2018.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Due to the implementation of British Columbia Instrument 51-509 on September 30, 2008 by the British Columbia Securities Commission, we have been deemed to be a British Columbia based reporting issuer. As such, we are required to file certain information and documents at www.sedar.com.
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Exhibit Number Description
___________101** Interactive Data Files 101.INS XBRL Instance Document 101.SCH XBRL Taxonomy Extension Schema Document 101.CAL XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF XBRL Taxonomy Extension Definition Linkbase Document 101.LAB XBRL Taxonomy Extension Label Linkbase Document 101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
* Incorporated by reference to same exhibit filed with the Company's Registration Statement on Form SB-2 dated January 10, 2006.
** Furnished herewith. Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files on Exhibit 101 hereto are deemed not filed or part of any registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, and otherwise are not subject to liability under those sections
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Pursuant to the requirements of Section 13 or 15(d) 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.
LEXARIA BIOSCIENCE CORP. |
| |
|
| |
By: | /s/ " John Docherty " |
|
| John Docherty, |
|
| President and Director |
|
| July 8, 2019 |
|
By: | /s/ " Chris Bunka " |
|
| Chris Bunka, |
|
| Chief Executive Officer, Chairman and Director |
|
| July 8, 2019 |
|
By: | /s/ " Allan Spissinger " |
|
| Allan Spissinger CPA, CA |
|
| Chief Financial Officer |
|
| July 8, 2019 |
|
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