UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported)  January 29, 2024 

 

Lexaria Bioscience Corp.

(Exact name of registrant as specified in its charter)

 

Nevada

 

000-52138

 

20-2000871

(State or other jurisdiction of incorporation)

 

(Commission File Number)

 

(IRS Employer Identification No.)

 

100 – 740 McCurdy Road, Kelowna, BC Canada

 

V1X 2P7

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code (250) 765-6424 

 

 _________________________________________________

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

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

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

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

Warrants to Purchase Common Stock

 

LEXX

LEXXW

 

The Nasdaq Capital Market

The Nasdaq Capital Market

 

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

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ 

 

 

 

 

Item 8.01 Other Events 

 

On January 29, 2024, Lexaria Bioscience Corp. (“Lexaria”) submitted its Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration for its planned U.S. phase 1b hypertension clinical trial HYPER-H23-1 entitled ‘A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension’.

 

The IND review process, which will take a minimum of 30 days, when successfully concluded will be an important milestone achievement for Lexaria demonstrating that its DehydraTECH technology has met high level formal regulatory scrutiny towards prospective future pharmaceutical commercial registration.

 

Lexaria looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions including funding.  The primary objective of the trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.

 

 
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SIGNATURES

 

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

 

LEXARIA BIOSCIENCE CORP.

 

 

/s/ Chris Bunka

Chris Bunka

CEO, Principal Executive Officer

 

Date: January 30, 2024

 

 

 
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Entity Address State Or Province BC
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Security Exchange Name NASDAQ
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Pre Commencement Issuer Tender Offer false
Entity Address Country CA

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