UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________________________________________________
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Item 3.01 | REGULATION FD DISCLOSURE |
On July 18, 2022, Alzamend Neuro, Inc. (the “Company”), issued a press release announcing that it received positive pre-investigational new drug response from the Food and Drug Administration for the AL001 treatment of bipolar disorder, major depressive disorder, and post-traumatic stress disorder. The Company expects topline data from AL001’s phase IIA multiple ascending dose clinical trial for the treatment of dementia related to Alzheimer’s, which trial commenced on May 5, 2022, to be available in December of 2022.
In accordance with General Instruction B.2 of Form 8-K, the information under this item shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing. This report will not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
The Securities and Exchange Commission encourages registrants to disclose forward-looking information so that investors can better understand the future prospects of a registrant and make informed investment decisions. This Current Report on Form 8-K and exhibits may contain these types of statements, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, and which involve risks, uncertainties and reflect the Registrant’s judgment as of the date of this Current Report on Form 8-K. Forward-looking statements may relate to, among other things, operating results and are indicated by words or phrases such as “expects,” “should,” “will,” and similar words or phrases. These statements are subject to inherent uncertainties and risks that could cause actual results to differ materially from those anticipated at the date of this Current Report on Form 8-K. Investors are cautioned not to rely unduly on forward-looking statements when evaluating the information presented within.
Item 9.01 | Financial Statements and Exhibits |
(d) | Exhibits: |
Exhibit No. | Description | |
99.1 | Press Release Issued on July 18, 2022. | |
101 | Pursuant to Rule 406 of Regulation S-T, the cover page is formatted in Inline XBRL (Inline eXtensible Business Reporting Language). | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101). |
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SIGNATURE
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.
ALZAMEND NEURO, INC. | ||
Dated: July 18, 2022 | /s/ Henry Nisser | |
Henry Nisser |
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Executive Vice President and General Counsel |
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