Form 8-K - Current report
January 30 2024 - 1:51PM
Edgar (US Regulatory)
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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.
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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