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UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
Washington, DC
20549
FORM
10-Q
x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended October
31, 2023
OR
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number: 001-40483
ALZAMEND NEURO, INC.
(Exact name of registrant as specified in its
charter)
Delaware |
81-1822909 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification Number) |
3480 Peachtree Road NE, Second Floor Suite 103, Atlanta, GA |
30326 |
(844) 722-6303 |
(Address of principal executive offices) |
(Zip Code) |
(Registrant’s telephone number, including area code) |
Securities registered under Section 12(b) of the
Act:
Title of Each Class |
Trading Symbol |
Name of each exchange on which registered |
Common Stock, $0.0001 par value per share |
ALZN |
NASDAQ Capital Market |
Securities registered under Section 12(g) of the
Act: None
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. Yes x No o
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 during the preceding
12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer |
o |
Accelerated filer o |
Non-accelerated filer |
x |
Smaller reporting company x |
Emerging growth company |
x |
|
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 o No x
As of December 14,
2023 there were 7,120,703 shares of registrant’s common stock, $0.0001
par value per share, outstanding.
Table of Contents
|
|
Page |
|
|
|
PART I. |
FINANCIAL INFORMATION |
3 |
Item 1. |
Financial Statements (unaudited) |
3 |
|
Condensed Balance Sheets |
3 |
|
Condensed Statements of Operations |
4 |
|
Condensed Statements of Stockholders’ (Deficit) Equity |
5 |
|
Condensed Statements of Cash Flows |
9 |
|
Notes to Condensed Financial Statements |
10 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
19 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
32 |
Item 4. |
Controls and Procedures |
32 |
|
|
|
PART II |
OTHER INFORMATION |
34 |
Item 1. |
Legal Proceedings |
34 |
Item 1A. |
Risk Factors |
34 |
Item 2. |
Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities. |
34 |
Item 3. |
Defaults Upon Senior Securities |
34 |
Item 4. |
Mine Safety Disclosures |
34 |
Item 5. |
Other Information |
34 |
Item 6. |
Exhibits |
35 |
|
Signatures |
36 |
PART I – FINANCIAL INFORMATION
| ITEM 1. | FINANCIAL STATEMENTS |
Alzamend Neuro, Inc.
Condensed Balance Sheets
(Unaudited)
| |
| | | |
| | |
| |
October 31, 2023 | | |
April 30, 2023 | |
ASSETS | |
| | | |
| | |
| |
| | | |
| | |
CURRENT ASSETS | |
| | | |
| | |
| |
| | | |
| | |
Cash | |
$ | 200,079 | | |
$ | 5,140,859 | |
Prepaid expenses and other current assets | |
| 581,802 | | |
| 447,589 | |
Prepaid expenses - related party | |
| - | | |
| 247,334 | |
TOTAL CURRENT ASSETS | |
| 781,881 | | |
| 5,835,782 | |
Property, plant and equipment, net | |
| 201,716 | | |
| 79,843 | |
TOTAL ASSETS | |
$ | 983,597 | | |
$ | 5,915,625 | |
| |
| | | |
| | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
| |
| | | |
| | |
Accounts payable and accrued liabilities | |
$ | 3,666,090 | | |
$ | 2,870,122 | |
TOTAL LIABILITIES, ALL CURRENT | |
| 3,666,090 | | |
| 2,870,122 | |
| |
| | | |
| | |
COMMITMENTS AND CONTINGENCIES | |
| | | |
| | |
| |
| | | |
| | |
STOCKHOLDERS’ (DEFICIT) EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Convertible Preferred stock, $0.0001
par value: 10,000,000
shares authorized; Series A Convertible Preferred Stock, $0.0001
stated value per share, 1,360,000
shares designated; nil 0 issued and outstanding as of October 31, 2023 and April 30, 2023 | |
| - | | |
| - | |
Common stock, $0.0001 par value: 300,000,000 shares authorized; 6,469,657 and 6,462,675 issued and outstanding as of October 31, 2023 and April 30, 2023, respectively | |
| 647 | | |
| 646 | |
Additional paid-in capital | |
| 62,699,614 | | |
| 62,000,814 | |
Note receivable for common stock – related party | |
| (14,876,293 | ) | |
| (14,883,295 | ) |
Accumulated deficit | |
| (50,506,461 | ) | |
| (44,072,662 | ) |
TOTAL STOCKHOLDERS’ (DEFICIT) EQUITY | |
| (2,682,493 | ) | |
| 3,045,503 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | |
$ | 983,597 | | |
$ | 5,915,625 | |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Operations
(Unaudited)
| |
| | | |
| | | |
| | | |
| | |
| |
For the Three Months Ended October 31, | | |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
OPERATING EXPENSES | |
| | | |
| | | |
| | | |
| | |
Research and development | |
$ | 1,996,783 | | |
$ | 1,532,985 | | |
$ | 4,362,920 | | |
$ | 2,908,940 | |
General and administrative | |
| 904,939 | | |
| 1,573,418 | | |
| 2,064,732 | | |
| 3,233,005 | |
Total operating expenses | |
| 2,901,722 | | |
| 3,106,403 | | |
| 6,427,652 | | |
| 6,141,945 | |
Loss from operations | |
| (2,901,722 | ) | |
| (3,106,403 | ) | |
| (6,427,652 | ) | |
| (6,141,945 | ) |
| |
| | | |
| | | |
| | | |
| | |
OTHER EXPENSE, NET | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (4,311 | ) | |
| (3,588 | ) | |
| (6,147 | ) | |
| (5,120 | ) |
Total other expense, net | |
| (4,311 | ) | |
| (3,588 | ) | |
| (6,147 | ) | |
| (5,120 | ) |
NET LOSS | |
$ | (2,906,033 | ) | |
$ | (3,109,991 | ) | |
$ | (6,433,799 | ) | |
$ | (6,147,065 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per common share | |
$ | (0.44 | ) | |
$ | (0.48 | ) | |
$ | (0.98 | ) | |
$ | (0.95 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted weighted average common shares
outstanding | |
| 6,563,784 | | |
| 6,499,230 | | |
| 6,563,230 | | |
| 6,499,008 | |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’
Deficit
For the Three Months Ended October 31, 2023
(Unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
Series A Convertible | | |
| | |
Additional | | |
Note Receivable for | | |
| | |
| |
| |
Preferred Stock | | |
Common Stock | | |
Paid-In | | |
Common Stock - | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Related Party | | |
Deficit | | |
Total | |
BALANCES, July 31, 2023 | |
| - | | |
$ | - | | |
| 6,462,675 | | |
$ | 646 | | |
$ | 62,370,194 | | |
$ | (14,883,295 | ) | |
$ | (47,600,428 | ) | |
$ | (112,883 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock for cash, net of issuance costs | |
| - | | |
| - | | |
| 6,149 | | |
| 1 | | |
| 18,086 | | |
| - | | |
| - | | |
| 18,087 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock for restricted stock awards | |
| - | | |
| - | | |
| 833 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Subscription receivable payment received | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7,002 | ) | |
| 7,002 | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation to employees and consultants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 318,336 | | |
| - | | |
| - | | |
| 318,336 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,906,033 | ) | |
| (2,906,033 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCES, October 31, 2023 | |
| - | | |
$ | - | | |
| 6,469,657 | | |
$ | 647 | | |
$ | 62,699,614 | | |
$ | (14,876,293 | ) | |
$ | (50,506,461 | ) | |
$ | (2,682,493 | ) |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’
(Deficit) Equity
For the Three Months Ended October 31, 2022
(Unaudited)
| |
Series A Convertible | | |
| | |
Additional | | |
Note Receivable for | | |
| | |
| |
| |
Preferred Stock | | |
Common Stock | | |
Paid-In | | |
Common Stock - | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Related Party | | |
Deficit | | |
Total | |
BALANCES, July 31, 2022 | |
| - | | |
$ | - | | |
| 6,365,453 | | |
$ | 637 | | |
$ | 58,296,002 | | |
$ | (14,883,295 | ) | |
$ | (32,231,569 | ) | |
$ | 11,181,775 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock for restricted stock awards | |
| - | | |
| - | | |
| 833 | | |
| 1 | | |
| (1 | ) | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation to employees and consultants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 715,639 | | |
| - | | |
| - | | |
| 715,639 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,109,991 | ) | |
| (3,109,991 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCES, October 31, 2022 | |
| - | | |
$ | - | | |
| 6,366,286 | | |
$ | 638 | | |
$ | 59,011,640 | | |
$ | (14,883,295 | ) | |
$ | (35,341,560 | ) | |
$ | 8,787,423 | |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’
(Deficit) Equity
For the Six Months Ended October 31, 2023
(Unaudited)
| |
Series A Convertible | | |
| | |
Additional | | |
Note Receivable for | | |
| | |
| |
| |
Preferred Stock | | |
Common Stock | | |
Paid-In | | |
Common Stock - | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Related Party | | |
Deficit | | |
Total | |
BALANCES, April 30, 2023 | |
| - | | |
$ | - | | |
| 6,462,675 | | |
$ | 646 | | |
$ | 62,000,814 | | |
$ | (14,883,295 | ) | |
$ | (44,072,662 | ) | |
$ | 3,045,503 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock for cash, net of issuance costs | |
| - | | |
| - | | |
| 6,149 | | |
| 1 | | |
| 18,086 | | |
| - | | |
| - | | |
| 18,087 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Subscription receivable payment received | |
| - | | |
| - | | |
| - | | |
| - | | |
| (7,002 | ) | |
| 7,002 | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation to employees and consultants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 687,716 | | |
| - | | |
| - | | |
| 687,716 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,433,799 | ) | |
| (6,433,799 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCES, October 31, 2023 | |
| - | | |
$ | - | | |
| 6,469,657 | | |
$ | 647 | | |
$ | 62,699,614 | | |
$ | (14,876,293 | ) | |
$ | (50,506,461 | ) | |
$ | (2,682,493 | ) |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’
Equity
For the Six Months Ended October 31, 2022
(Unaudited)
| |
Series A Convertible | | |
| | |
Additional | | |
Note Receivable for | | |
| | |
| |
| |
Preferred Stock | | |
Common Stock | | |
Paid-In | | |
Common Stock - | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Related Party | | |
Deficit | | |
Total | |
BALANCES, April 30, 2022 | |
| - | | |
$ | - | | |
| 6,365,453 | | |
$ | 637 | | |
$ | 57,428,664 | | |
$ | (14,883,295 | ) | |
$ | (29,194,495 | ) | |
$ | 13,351,511 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock for restricted stock awards | |
| - | | |
| - | | |
| 833 | | |
| 1 | | |
| (1 | ) | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation to employees and consultants | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,582,977 | | |
| - | | |
| - | | |
| 1,582,977 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,147,065 | ) | |
| (6,147,065 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCES, October 31, 2022 | |
| - | | |
$ | - | | |
| 6,366,286 | | |
$ | 638 | | |
$ | 59,011,640 | | |
$ | (14,883,295 | ) | |
$ | (35,341,560 | ) | |
$ | 8,787,423 | |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Condensed Statements of Cash Flows
(Unaudited)
| |
| | | |
| | |
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (6,433,799 | ) | |
$ | (6,147,065 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation expense | |
| 25,370 | | |
| 12,420 | |
Stock-based compensation to employees and consultants | |
| 687,716 | | |
| 1,582,977 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| (134,213 | ) | |
| (59,851 | ) |
Prepaid expenses - related party | |
| 247,334 | | |
| 245,251 | |
Accounts payable and accrued liabilities | |
| 795,968 | | |
| (514,731 | ) |
Net cash used in operating activities | |
| (4,811,624 | ) | |
| (4,880,999 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Purchase of equipment | |
| (147,243 | ) | |
| - | |
Net cash used in investing activities | |
| (147,243 | ) | |
| - | |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from the issuance of common stock, net | |
| 18,087 | | |
| - | |
Net cash provided by financing activities | |
| 18,087 | | |
| - | |
Net decrease in cash | |
| (4,940,780 | ) | |
| (4,880,999 | ) |
Cash at beginning of period | |
| 5,140,859 | | |
| 14,063,811 | |
Cash at end of period | |
$ | 200,079 | | |
$ | 9,182,812 | |
The accompanying notes are an integral part of
these unaudited condensed financial statements.
Alzamend Neuro, Inc.
Notes to Unaudited Condensed Financial Statements
| 1. | DESCRIPTION OF BUSINESS |
Organization
Alzamend Neuro, Inc. (the
“Company” or “Alzamend”), is a clinical-stage biopharmaceutical company focused on developing novel products for
the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder
(“MDD”) and post-traumatic stress disorder (“PTSD”). With two current product candidates, Alzamend aims to bring
treatments or cures to market at a reasonable cost as quickly as possible. The Company’s current pipeline consists of two novel
therapeutic drug candidates: (i) a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate,
known as AL001, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and (ii) a patented method using a mutant peptide sensitized cell as a cell-based therapeutic
vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s, known as ALZN002, through
a royalty-bearing exclusive worldwide license from the same Licensor.
The Company is devoting substantially
all its efforts towards research and development of its two product candidates and raising capital. The Company has not generated any
product revenue to date. The Company has financed its operations to date primarily through debt financings and through the sale of its
common stock, par value $0.0001 per share (“Common Stock”). The Company expects to continue to incur net losses in the foreseeable
future.
Reverse Stock Split
On October 27, 2023, pursuant to the authorization provided by the
Company’s stockholders at a special meeting of stockholders, the Company filed an amendment to the Certificate of Incorporation
to effectuate a reverse stock split of the Company’s issued and outstanding Common Stock by a ratio of one-for-fifteen (the “Reverse
Split”). The Reverse Split did not affect the number of authorized shares of Common Stock, preferred stock or their respective par
value per share. As a result of the Reverse Split, each fifteen shares of Common Stock issued and outstanding prior to the Reverse Split
were converted into one share of common stock. The Reverse Split became effective in the State of Delaware on October 31, 2023. All share
amounts in these condensed financial statements have been updated for all periods presented to reflect the Reverse Split.
| 2. | LIQUIDITY AND GOING CONCERN |
The accompanying condensed financial statements have been prepared
on the basis that the Company will continue as a going concern. As of October 31, 2023, the Company had cash of $200,000, an accumulated
deficit of $50.5 million and stockholders’ deficit of $2.7 million. For the three and six months ended October 31, 2023, the Company
had net losses of $2.9 million and $6.4 million, respectively. For the six months ended October 31, 2023, cash used in operating activities
was $4.8 million. Historically, the Company has financed its operations principally through issuances of equity and debt instruments.
The Company believes its current
cash on hand is not sufficient to fund its planned operations through one year after the date the condensed financial statements are issued.
These factors create substantial doubt about the Company’s ability to continue as a going concern for at least one year after the
date that these condensed financial statements are issued.
The Company’s inability to continue as a going concern could have
a negative impact on the company, including our ability to obtain needed financing. The Company’s condensed
financial statements do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts
and classifications of liabilities that might be necessary should it be unable to continue as a going concern.
In order to continue as a
going concern, the Company will need to raise additional funds. The Company has raised funds subsequent to the quarter end through an
“at-the-market” offering, and plans to seek additional funding through public equity, including the “at-the-market”
offering, private equity and debt financings. Additional funds may also be received from the exercise of warrants (Note 7) and the receipt
of funds from the note receivable (Note 4). The terms of any additional financing may adversely affect the holdings or rights of the Company’s
stockholders. If the Company is unable to obtain funding, it could be required to delay, reduce or eliminate research and development
programs and planned clinical trials which could adversely affect the Company’s business operations.
| 3. | SIGNIFICANT ACCOUNTING POLICIES |
Basis of Presentation
The accompanying condensed financial statements of the Company have
been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and
the rules of the Securities and Exchange Commission (“SEC”) applicable to interim reports of companies filing as a smaller
reporting company. These condensed financial statements should be read in conjunction with the audited financial statements and notes
thereto contained in the Company’s Report on Form 10-K for the year ended April 30, 2023, filed with the SEC on July 27, 2023. In
the opinion of management, the accompanying condensed interim financial statements include all adjustments necessary in order to make
the condensed financial statements not misleading. The results of operations for interim periods are not necessarily indicative of the
results to be expected for the full year or any other future period. Certain notes to the condensed financial statements that would substantially
duplicate the disclosures contained in the audited financial statements for the most recent fiscal year as reported in the Company’s
Report on Form 10-K have been omitted. The accompanying condensed balance sheet at April 30, 2023 has been derived from the audited balance
sheet at April 30, 2023 contained in such Form 10-K.
Accounting Estimates
The preparation of condensed financial statements, in conformity with
U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the
reporting period. The Company’s significant accounting policies that involve significant judgment and estimates include stock-based
compensation, warrant valuation, and valuation of deferred income taxes. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all
highly liquid investments with a remaining maturity of three months or less when purchased to be cash equivalents. As of October 31, 2023
and April 30, 2023, the Company had no cash equivalents.
Fair Value of Financial
Instruments
Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, defines fair value
as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques
used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy
is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last
is considered unobservable:
Level 1: Quoted prices in
active markets for identical assets or liabilities.
Level 2: Inputs other than
Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the
full term of the assets or liabilities.
Level 3 assumptions: Unobservable
inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including
liabilities resulting from imbedded derivatives associated with certain warrants to purchase Common Stock.
The fair values of warrants
are determined using the Black-Scholes valuation model, a “Level 3” fair value measurement, based on the estimated fair value
of Common Stock, volatility based on the historical volatility data of similar companies, considering the industry, products and market
capitalization of such other entities, the expected life based on the remaining contractual term of the warrants and the risk free interest
rate based on the implied yield available on U.S. Treasury Securities with a maturity equivalent to the warrants’ contractual life.
Property and Equipment,
Net
Property and equipment are
stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life
of five years. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred.
Research and Development
Expenses
Research and development costs
are expensed as incurred. Research and development costs consist of scientific consulting fees, clinical trial fees and lab supplies,
as well as fees paid to other entities that conduct certain research and development activities on behalf of the Company.
The Company has acquired and
may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire
license, products or rights, as well as any future milestone payments, are immediately recognized as research and development expense
provided that there is no alternative future use of the rights in other research and development projects.
Stock-Based Compensation
The Company recognizes stock-based
compensation expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they
occur. The Company’s stock-based compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes
option pricing model. To the extent any stock option grants are made subject to the achievement of a performance-based milestone, management
evaluates when the achievement of any such performance-based milestone is probable based on the relative satisfaction of the performance
conditions as of the reporting date.
The Company recognizes stock-based
compensation expense for restricted stock units on a straight-line basis over the requisite service period and account for forfeitures
as they occur. The Company’s stock-based compensation for restricted stocks is based upon the estimated fair value of the Common
Stock.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. Certain of such assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and the
Company uses significantly different assumptions or estimates, the Company’s stock-based compensation could be materially different.
Warrants
The Company accounts for stock
warrants as either equity instruments, derivative liabilities, or liabilities in accordance with FASB ASC 480, Distinguishing
Liabilities from Equity and FASB ASC 815, Derivatives and Hedging, depending on the specific terms of the warrant
agreement.
Loss
per Common Share
The Company utilizes FASB
ASC 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common stockholders by the weighted-average
number of common shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is
increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued
and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible
preferred stock, options and warrants were to be exercised or converted or otherwise resulted in the issuance of Common Stock that then
shared in the earnings of the entity.
Since the effects of outstanding
stock options, restricted stock units and warrants are anti-dilutive in the periods presented, shares of Common Stock underlying these
instruments have been excluded from the computation of loss per common share.
The following sets forth the
number of shares of Common Stock underlying outstanding stock options, restricted stock units and warrants that have been excluded from
the computation of loss per common share:
Schedule of antidilutive securities excluded from computation of earnings per share | |
| | | |
| | |
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | |
Stock options (1) | |
| 1,210,554 | | |
| 1,687,209 | |
Restricted stock units | |
| 2,500 | | |
| 4,167 | |
Warrants | |
| 676,649 | | |
| 676,649 | |
| |
| 1,889,703 | | |
| 2,368,025 | |
Recent Accounting Standards
From time to time, new accounting
pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact
of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s financial position
or results of operations upon adoption.
The Company has considered all other recently issued accounting standards
and does not believe the adoption of such standards will have a material impact on its condensed financial statements.
| 4. | NOTE RECEIVABLE FOR COMMON STOCK, RELATED PARTY |
On April 30, 2019, the Company
and Ault Life Sciences Fund, LLC (“ALSF”) entered into a securities purchase agreement for the purchase of 666,666 shares
of Common Stock for a total purchase price of $15,000,000, or $22.50 per share with 333,333 warrants with a 5-year life and an exercise
price of $45.00 per share and vesting upon issuance. The total purchase price of $15,000,000 was in the form of a non-interest bearing
note receivable with a 12-month term from ALSF, a related party. In November 2019, the term of the note receivable was extended to December
31, 2021, and in May 2021, the term of the note receivable was extended to December 31, 2023. The note is secured by a pledge of the purchased
shares. As the note receivable from ALSF is related to the issuance of Common Stock, it is recorded as an offset to additional paid-in
capital. At October 31, 2023 and April 30, 2023, the outstanding balance of the note receivable was $14,876,293 and $14,883,295, respectively.
ALSF is wholly owned by Ault Life Sciences, Inc. (“ALSI”). ALSI is majority owned by Ault & Company, Inc. (“Ault
& Co.”). Messrs. Horne and Nisser, directors of the Company, are also directors of Ault & Co.
5. PREPAID
EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other
current assets were as follows:
Schedule of prepaid expenses and other current assets | |
| | | |
| | |
| |
October 31, 2023 | | |
April 30, 2023 | |
Prepaid clinical trial fees | |
$ | 326,211 | | |
$ | 352,635 | |
Prepaid insurance | |
| 235,576 | | |
| 92,154 | |
Other prepaid expenses | |
| 20,015 | | |
| 2,800 | |
Total prepaid expenses and other current assets | |
$ | 581,802 | | |
$ | 447,589 | |
Prepaid clinical trial fees
at October 31, 2023 and April 30, 2023 represented the unused portion of the prepaid clinical trial fees. On June 14, 2023, the Company purchased directors’ and officers’
insurance for 12 months in the amount of $337,000. Prepaid insurance at October
31, 2023 represented the unamortized portion of directors’ and officers’ insurance.
| 6. | STOCK-BASED COMPENSATION |
2016 Stock Incentive
Plan
On April 30, 2016, the Company’s
stockholders approved the Company’s 2016 Stock Incentive Plan (the “Plan”). The Plan provides for the issuance of a
maximum of 833,333 shares of Common Stock to be offered to the Company’s directors, officers, employees, and consultants. On March
1, 2019, the Company’s stockholders approved an additional 500,000 shares to be available for issuance under the Plan. Options granted
under the Plan have an exercise price equal to or greater than the fair value of the underlying Common Stock at the date of grant and
become exercisable based on a vesting schedule determined at the date of grant. The options expire between five and 10 years from the
date of grant. Restricted stock awards granted under the Plan are subject to a vesting period determined at the date of grant.
2021 Stock Incentive
Plan
In February 2021, the Company’s
board of directors (the “Board”) adopted, and the stockholders approved, the Alzamend Neuro, Inc. 2021 Stock Incentive Plan
(the “2021 Plan”). The 2021 Plan authorizes the grant to eligible individuals of (1) stock options (incentive and non-statutory),
(2) restricted stock, (3) stock appreciation rights, or SARs, (4) restricted stock units, and (5) other stock-based compensation.
Stock Subject to the 2021
Plan. The maximum number of shares of Common Stock that may be issued under the 2021 Plan is 666,667 shares, which number will
be increased to the extent that compensation granted under the 2021 Plan is forfeited, expires or is settled for cash (except as otherwise
provided in the 2021 Plan). Substitute awards (awards made or shares issued by the Company in assumption of, or in substitution or exchange
for, awards previously granted, or the right or obligation to make future awards, in each case by a company that the Company acquires
or any subsidiary of the Company or with which the Company or any subsidiary combines) will not reduce the shares authorized for grant
under the 2021 Plan, nor will shares subject to a substitute award be added to the shares available for issuance or transfer under the
2021 Plan.
All options that the Company
grants are granted at the per share fair value on the grant date. Vesting of options differs based on the terms of each option. The Company
has valued the options at their date of grant utilizing the Black-Scholes option pricing model. As of the date of issuance of these options,
there was not an active public market for the Company’s shares. Accordingly, the fair value of the underlying options was determined
based on the historical volatility data of similar companies, considering the industry, products and market capitalization of such other
entities. The risk-free interest rate used in the calculations is based on the implied yield available on U.S. Treasury issues with an
equivalent term approximating the expected life of the options as calculated using the simplified method. The expected life of the options
used was based on the contractual life of the option granted. Stock-based compensation is a non-cash expense because the Company settles
these obligations by issuing shares of Common Stock from its authorized shares instead of settling such obligations with cash payments.
A summary of stock option
activity for the six months ended October 31, 2023 is presented below:
Schedule of share-based payment arrangement, option, activity | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
Outstanding Options | |
| |
Shares Available for Grant | | |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (years) | | |
Aggregate Intrinsic Value | |
Balance at April 30, 2023 | |
| 612,778 | | |
| 987,222 | | |
$ | 18.96 | | |
| 6.18 | | |
$ | 819,900 | |
Options granted | |
| - | | |
| - | | |
$ | - | | |
| - | | |
| | |
Options exercised | |
| - | | |
| - | | |
$ | - | | |
| - | | |
| | |
Options expired | |
| 7,222 | | |
| (7,222 | ) | |
$ | 75.00 | | |
| - | | |
| | |
Balance at October 31, 2023 | |
| 620,000 | | |
| 980,000 | | |
$ | 18.96 | | |
| 5.72 | | |
$ | 174,500 | |
Options vested and expected to vest at October 31, 2023 | | |
| 913,334 | | |
$ | 17.83 | | |
| 5.47 | | |
$ | 174,500 | |
Options exercisable at October 31, 2023 | |
| | | |
| 895,679 | | |
$ | 17.39 | | |
| 4.37 | | |
$ | 174,500 | |
The aggregate intrinsic value
in the table above represents the total pretax intrinsic value (i.e., the difference between the estimated fair value on the respective
date and the exercise price, times the number of shares) that would have been received by the option holders had all option holders exercised
their options.
Restricted stock unit activity
for the six months ended October 31, 2023 is presented below:
| | |
| | | |
| | |
| | |
Shares | | |
Weighted Average
Grant Date Fair Value | |
Unvested at April 30, 2023 | | |
| 3,333 | | |
$ | 2.50 | |
Granted | | |
| - | | |
| - | |
Vested | | |
| (833 | ) | |
| 2.50 | |
Cancelled | | |
| - | | |
| - | |
Unvested at October 31, 2023 | | |
| 2,500 | | |
$ | 2.50 | |
Performance Contingent
Stock Options Granted to Employee
On November 26, 2019, the
Board granted 283,333 performance- and market-contingent awards to certain key employees and a director. These grants were made outside
of the Plan. These awards have an exercise price of $22.50 per share. These awards have multiple separate market triggers for vesting
based upon either (i) the successful achievement of tiered target closing prices on a national securities exchange for 90 consecutive
trading days later than 180 days after the Company’s initial public offering (“IPO”) for its Common Stock, or (ii) tiered
target prices for a change in control transaction. The target prices ranged from $150 per share to $600 per share. In the event any of
the stock price milestones are not achieved within three years, the unvested portion of the performance options will be reduced by 25%.
On November 22, 2022, the
Compensation Committee of the Board modified the performance criteria for these awards. The target price range is now $150 per share to
$300 per share. Additionally, if the stock price milestones are now not achieved by November 27, 2026, as opposed to within three years,
the unvested portion of the performance options will be reduced by 25%. Due to the significant risks and uncertainties associated with
achieving the market-contingent awards, as of October 31, 2023, the Company believed that the achievement of the requisite performance
conditions was not probable and, as a result, no compensation cost has been recognized for these awards.
On November 29, 2022, the
Compensation Committee of the Board granted 133,333 performance-based stock option to the Chief Executive Officer at an exercise price
of $17.55 per share, of which 50% vest upon the completion and announcement of topline data from the Company’s Phase II clinical
trial of AL001 within three years from grant date and the remaining 50% vest upon the completion and announcement of topline data from
the Company’s Phase I/IIA clinical trial of ALZN002 within four years from the grant date. During the three months ended January
31, 2023, the Company believed that it was probable that the performance condition of the completion and announcement of topline data
from the Company’s Phase II clinical trial of AL001 would be achieved and had recognized the related stock-based compensation. As
of October 31, 2023, the Company believed that the achievement of the second performance condition was not probable and, as a result,
no compensation cost has been recognized related to Phase I/IIA of ALZN002.
Performance Contingent
Stock Options Granted to TAMM Net
On March 23, 2021, the Company
issued performance-based stock options to certain team members at TAMM Net, Inc. (“TAMM Net”) to purchase an aggregate of
30,000 shares of Common Stock at a per share exercise price of $22.50 per share, of which 50% would vest upon the completion of Phase
I of AL001 by March 31, 2022, and the remaining 50% would vest upon completion of Phase I/IIA of ALZN002 by December 31, 2022.
The performance goal of completing Phase I of AL001 was achieved on
March 22, 2022, and the Company recognized stock-based compensation related to the completion of Phase I of AL001 over the implied service
period to complete this milestone.
On January 19, 2023, the Board
modified the performance criteria for these awards. The remaining 50% of the grant will now vest upon the completion and announcement
of topline data of the first cohort from a Phase I/IIA clinical trial of ALZN002 on/or before March 31, 2024. Due to the significant risks
and uncertainties associated with achieving the completion of Phase I/IIA for ALZN002, as of October 31, 2023, the Company believed that
the achievement of the requisite performance conditions was not probable and, as a result, no compensation cost has been recognized for
these awards related to ALZN002.
Performance Contingent
Stock Options Granted to Consultants
On October 14, 2021, the Company
issued performance-based stock options to two consultants to purchase an aggregate of 13,333 shares of Common Stock with an exercise price
of $36.30 per share, of which 3,333 vest upon completion of each of the Phase II clinical trials of AL001 for a BD indication, AL001 for
a PTSD indication, AL001 for an MDD indication and ALZN002 for an Alzheimer’s indication.
On January 19, 2023, the Board
modified the performance criteria for these awards. The revised grant will vest 25% if the Company (a) completes and announces topline
data from a Phase II clinical trial of AL001 and ALZN002, as applicable, that would support a new drug application for the drug candidate
and the indication listed below, and (b) obtained a “Study May Proceed” letter from the U.S. Food and Drug Administration
(“FDA”) for the additional Investigational New Drug (“IND”) on/or before December 31, 2023, as follows: (i) AL001
– bipolar disorder; (ii) AL001- major depressive disorder; (iii) AL001 – post-traumatic stress disorder; and (iv) ALZN002
– Alzheimer’s disease.
During the three months ended
October 31, 2023, the Company filed INDs for BD and MDD and received “Study May Proceed” letter for BD in October 2023 and
MDD in November 2023. As a result, 50% of the performance grant vested and the Company recognized stock-based compensation related to
the vesting and the probability of achieving the MDD criteria. As of October 31, 2023, the Company believed that the achievement of the
remaining requisite performance conditions was not probable and, as a result, no compensation cost has been recognized for these awards
related to Phase II of AL001 – post-traumatic stress disorder and ALZN002 – Alzheimer’s disease.
Stock-Based Compensation
Expense
The Company’s results
of operations included expenses relating to stock-based compensation for three and six months ended October 31, 2023 and 2022 comprised
as follows:
Schedule of stock-based compensation | |
| | |
| | |
| | |
| |
| |
For the Three Months Ended October 31, | | |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 142,603 | | |
$ | - | | |
$ | 142,603 | | |
$ | - | |
General and administrative | |
| 175,733 | | |
| 715,639 | | |
| 545,113 | | |
| 1,582,977 | |
Total stock-based compensation | |
$ | 318,336 | | |
$ | 715,639 | | |
$ | 687,716 | | |
$ | 1,582,977 | |
As of October 31, 2023, total
unamortized stock-based compensation expense related to unvested employee and non-employee awards that are expected to vest was $518,000.
The weighted-average period over which such stock-based compensation expense will be recognized was approximately 1.7 years.
The following table summarizes
information about Common Stock warrants outstanding and exercisable at October 31, 2023:
Schedule of common stock warrants outstanding | |
| | | |
| | | |
| | |
| | | |
| | |
Outstanding | |
Exercisable | |
| |
| | |
Weighted | | |
| |
| | |
| |
| |
| | |
Average | | |
Weighted | |
| | |
Weighted | |
| |
| | |
Remaining | | |
Average | |
| | |
Average | |
Exercise | |
Number | | |
Contractual | | |
Exercise | |
Number | | |
Exercise | |
Price | |
Outstanding | | |
Life (years) | | |
Price | |
Exercisable | | |
Price | |
$15.00 | |
| 33,333 | | |
| 0.3 | | |
$ | 15.00 | |
| 33,333 | | |
$ | 15.00 | |
$26.25 | |
| 10,756 | | |
| 1.0 | | |
$ | 26.25 | |
| 10,756 | | |
$ | 26.25 | |
$45.00 | |
| 628,477 | | |
| 1.4 | | |
$ | 45.00 | |
| 628,477 | | |
$ | 45.00 | |
$93.75 | |
| 4,083 | | |
| 2.6 | | |
$ | 93.75 | |
| 4,083 | | |
$ | 93.75 | |
| |
| | | |
| | | |
| | |
| | | |
| | |
$15.00 - $93.75 | |
| 676,649 | | |
| 1.4 | | |
$ | 43.52 | |
| 676,649 | | |
$ | 43.52 | |
| 8. | COMMITMENTS AND CONTINGENCIES |
Contractual Obligations
On
July 2, 2018, the Company entered into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and
its affiliate, the University of South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted the Company
a royalty bearing exclusive worldwide licenses limited to the field of Alzheimer’s, under United States Patent Nos. (i) 9,840,521,
entitled “Organic Anion Lithium Ionic Cocrystal Compounds and Compositions”, filed September 24, 2015 and granted December
12, 2017, and (ii) 9,603,869, entitled “Lithium Co-Crystals for Treatment of Neuropsychiatric Disorders”, filed May 21, 2016
and granted March 28, 2017. On February 1, 2019, the Company entered into the First Amendments to the AL001 Licenses, on March 30, 2021,
the Company entered into the Second Amendments to the AL001 Licenses and on June 8, 2023, the Company entered into the Third Amendments
to the AL001 Licenses (collectively, the “AL001 License Agreements”). The Third Amendments to the AL001 Licenses modified
the timing of the payments for the license fees.
The
AL001 License Agreements require that the Company pay combined royalty payments of 4.5% on net sales of products developed from
the licensed technology for AL001. The Company has already paid an initial license fee of $200,000 for AL001. As an additional
licensing fee for the license of the AL001 technologies, the Licensor received 148,528 shares of Common Stock. Minimum royalties
for AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary
of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every year thereafter, for the
life of the AL001 License Agreements.
On May 1, 2016, the Company entered into a Standard Exclusive License
Agreement with Sublicensing Terms for ALZN002 with the Licensor (the “ALZN002 License”), pursuant to which the Licensor granted
the Company a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy and Diagnostics, under
United States Patent No. 8,188,046, entitled “Amyloid Beta Peptides and Methods of Use”, filed April 7, 2009 and granted May
29, 2012. On August 18, 2017, the Company entered into the First Amendment to the ALZN002 License, on May 7, 2018, the Company entered
into the Second Amendment to the ALZN002 License, on January 31, 2019, the Company entered into the Third Amendment to the ALZN002 License,
on January 24, 2020, the Company entered into the Fourth Amendment to the ALZN002 License, on March 30, 2021, the Company entered into
the Fifth Amendment to the ALZN002 License, on April 17, 2023, the Company entered into the Sixth Amendment to the ALZN002 License and
on December 11, 2023, the Company entered into the Seventh Amendment to the ALZN002 License (collectively, the “ALZN002 License
Agreement”). The Seventh Amendment to the ALZN002 License modified the timing of the payments for the license fees.
The
ALZN002 License Agreement requires the Company to pay royalty payments of 4% on net sales of products developed from the licensed
technology for ALZN002. The Company has already paid an initial license fee of $200,000 for ALZN002. As an additional licensing
fee for the license of ALZN002, the Licensor received 240,120 shares of Common Stock. Minimum royalties for ALZN002 are $20,000 on
the first anniversary of the first commercial sale, $40,000 on the second anniversary of the first commercial sale and $50,000 on
the third anniversary of the first commercial sale and every year thereafter, for the life of the ALZN002 License Agreement.
On
November 19, 2019, the Company entered into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications
of AL001 with the Licensor (the “November AL001 License”), pursuant to which the Licensor granted the Company a royalty bearing
exclusive worldwide licenses limited to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric
diseases and disorders. On March 30, 2021, the Company entered into the First Amendments to the November AL001 License and on April 17,
2023, the Company entered into the Second Amendments to the November AL001 License (collectively, the “November AL001 License Agreements”).
The Second Amendments to the November AL001 License modified the timing of the payments for the license fees.
The
November AL001 License Agreements require the Company to pay royalty payments of 3% on net sales of products developed from
the licensed technology for AL001 in those fields. The Company paid an initial license fee of $20,000 for the additional indications.
Minimum royalties for November AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on
the second anniversary of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every
year thereafter, for the life of the November AL001 License Agreements.
These
license agreements have an indefinite term that continue until the later of the date no licensed patent under the applicable agreement
remains a pending application or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory
body, or the date on which the Company’s obligations to pay royalties expire under the applicable license agreement. Under the various
license agreements, if the Company fails to meet a milestone by its specified date, Licensor may terminate the license agreement. The
Licensor was also granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by
the Company while the Licensor remains the owner of any equity securities of the Company.
Additionally,
the Company is required to pay milestone payments on the due dates to the Licensor for the license of the AL001 technologies and for the
ALZN002 technology, as follows:
Original AL001 Licenses:
|
Schedule of contractual obligation, fiscal year maturity |
|
|
|
|
Payment |
|
Due Date |
|
Event |
$ |
50,000 |
* |
Completed September 2019 |
|
Pre-IND meeting |
|
|
|
|
|
|
$ |
65,000 |
* |
Completed June 2021 |
|
IND application filing |
|
|
|
|
|
|
$ |
190,000 |
* |
Completed December 2021 |
|
Upon first dosing of patient in a clinical trial |
|
|
|
|
|
|
$ |
500,000 |
* |
Completed March 2022 |
|
Upon completion of first clinical trial |
|
|
|
|
|
|
$ |
1,250,000 |
|
March 2025 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
10,000,000 |
|
8 years from the effective date of the agreement |
|
Upon FDA approval |
ALZN002 License:
Payment |
|
Due Date |
$ |
50,000 |
* |
Completed January 2022 |
|
|
|
|
$ |
50,000 |
|
Upon first dosing of patient in first Phase I clinical trial |
|
|
|
|
$ |
500,000 |
|
Upon completion of first Phase IIb clinical trial |
|
|
|
|
$ |
1,000,000 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
$ |
10,000,000 |
|
Upon first commercial sale |
Additional
AL001 Licenses:
Payment |
|
Due Date |
|
Event |
$ |
2,000,000 |
|
March 2026 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
16,000,000 |
|
August 1, 2029 |
|
First commercial sale |
The
Company is authorized to issue 10,000,000 shares of Preferred Stock $0.0001 par value. The Board has designated 1,360,000 shares as the
Series A Convertible Preferred Stock. The rights, preferences, privileges and restrictions on the remaining authorized 8,640,000 shares
of Preferred Stock have not been determined. The Board is authorized to create a new series of preferred shares and determine the number
of shares, as well as the rights, preferences, privileges and restrictions granted to or imposed upon any series of preferred shares.
Series A Convertible
Preferred Stock
As of October 31, 2023, there
were no shares of Series A Convertible Preferred Stock issued or outstanding.
Common Stock
ALSF Investment
On April 30, 2019, the Company
and ALSF entered into a securities purchase agreement (the “SPA”) for the purchase of 666,667 shares of Common Stock for a
total purchase price of $15,000,000, or $22.50 per share with 333,333 warrants with a 5-year life and an exercise price of $45.00 per
share and vesting upon issuance. The total purchase price of $15,000,000 was in the form of a non-interest bearing note receivable with
a 12-month term from ALSF, a related party. The note is secured by a pledge of the purchased shares. Pursuant to the SPA, ALSF is entitled
to full ratchet anti-dilution protection, most-favored nation status, denying the Company the right to enter into a variable rate transaction
absent its consent, a right to participate in any future financing the Company may consummate and to have all the shares of Common Stock
to which it is entitled under the SPA registered under the Securities Act within 180 days of the final closing of the IPO. In May 2021,
the term of the note receivable was extended to December 31, 2023. The note is secured by a pledge of the purchased shares.
At-the-Market Offering
On September 8, 2023, the
Company entered into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC, as sales agent to sell shares of
its Common stock, having an aggregate offering price of up to approximately $9.8 million (the “Shares”) from time to time,
through an “at the market offering” (the “ATM Offering”) as defined in Rule 415 under the Securities Act of 1933,
as amended (the “Securities Act”). On September 8, 2023, the Company filed a prospectus supplement with the SEC relating to
the offer and sale of up to approximately $9.8 million in shares of Common Stock in the ATM Offering.
The offer and sale of the
Shares will be made pursuant to the Company’s effective “shelf” registration statement on Form S-3 and an accompanying
base prospectus contained therein (Registration Statement No. 333-273610) filed with the SEC on August 2, 2023 and declared effective
by the SEC on August 10, 2023.
During the six months ended
October 31, 2023, the Company sold an aggregate of 6,149 shares of Common Stock pursuant to the ATM Offering for gross proceeds of $19,000.
| 10. | OTHER RELATED PARTY TRANSACTIONS |
In November 2022, the Company
entered into a marketing and brand development agreement with Ault Alliance, Inc. (“AULT”), effective August 1, 2022, whereby
AULT will provide various marketing services over twelve months valued at $1.4 million. The Company had the right to pay the fee in cash
or shares of its common stock with a value of $22.50 per share. On November 11, 2022, the Company elected to pay the fee with 62,222 shares
of its common stock. The Company recorded the value of the agreement using the closing price of the Company’s common stock on November
11, 2022, and amortizes the expense over twelve months beginning in August 2022. At October 31, 2023, the balance of related party prepaid
expenses was zero.
During
the period between November 1, 2023 through December 14, 2023, the Company sold an aggregate of 651,046 shares of Common Stock pursuant
to the ATM Offering for gross proceeds of $849,000.
On
December 11, 2023, the Company entered into the Seventh Amendment to the ALZN002 License. The Seventh Amendment to the ALZN002
License modified the timing of the payments for the license fees.
| ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
You should read the following management’s
discussion and analysis of financial condition and results of operations in conjunction with our unaudited condensed financial statements
and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related
notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report
on Form 10-K, filed with the Securities and Exchange Commission, or the SEC, on July 27, 2023.
NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”),
and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This section should be read in conjunction
with our unaudited condensed financial statements and related notes included in Part I, Item 1 of this report. The statements contained
in this report that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act and
Section 21E of the Exchange Act.
These statements relate to future events
or our future financial performance. We have attempted to identify forward-looking statements by terminology including “anticipates,”
“believes,” “expects,” “can,” “continue,” “could,” “estimates,”
“expects,” “intends,” “may,” “plans,” “potential,” “predict,”
“should” or “will” or the negative of these terms or other comparable terminology. These statements are only predictions;
uncertainties and other factors may cause our actual results, levels of activity, performance or achievements to be materially different
from any future results, levels or 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.
In this Quarterly Report, unless the context
requires otherwise, references to the “Company,” “Alzamend,” “we,” “our company” and “us”
refer to Alzamend Neuro, Inc., a Delaware corporation.
Overview
We
were incorporated on February 26, 2016, as Alzamend Neuro, Inc. under the laws of the State of Delaware. We were formed to acquire and
commercialize patented intellectual property and know-how to prevent, treat and potentially cure the crippling and deadly Alzheimer’s.
With our two product candidates, we aim to bring treatment or cures not only for Alzheimer’s, but also, bipolar disorder (“BD”),
major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”). Existing Alzheimer’s treatments
only temporarily relieve symptoms but do not, to our knowledge, slow or halt the underlying worsening of the disease. We have developed
a novel approach to combat Alzheimer’s through immunotherapy.
Critical Accounting Policies and Estimates
Research and Development Expenses. Research
and development costs are expensed as incurred. Research and development costs consist of scientific consulting fees and lab supplies,
as well as fees paid to other entities that conduct certain research and development activities on behalf of our company.
We have acquired and may continue to acquire
the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire license, product or
rights, as well as any future milestone payments, are immediately recognized as research and development expense provided that there is
no alternative future use of the rights in other research and development projects.
Stock-Based Compensation. We
maintain a stock-based compensation plan as a long-term incentive for employees, non-employee directors and consultants. The plan allows
for the issuance of incentive stock options, non-qualified stock options, restricted stock units, and other forms of equity awards.
We recognize stock-based compensation expense
for stock options on a straight-line basis over the requisite service period and account for forfeitures as they occur. Our stock-based
compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes option pricing model. To the
extent any stock option grants are made subject to the achievement of a performance-based milestone, management evaluates when the achievement
of any such performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting
date.
The Black-Scholes option pricing model utilizes
inputs which are highly subjective assumptions and generally require significant judgment. These assumptions include:
| · | Fair Value of Common Stock. See the subsection titled “Common Stock Valuations”
below. |
| · | Risk-Free Interest Rate. The risk-free interest rate is based on the U.S. Treasury
zero coupon issues in effect at the time of grant for periods corresponding with the expected term of the option. |
| · | Expected Volatility. Because we do not have a sufficient trading history for our common
stock (“Common Stock”), the expected volatility was estimated based on the average volatility for comparable publicly traded
life sciences companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based
on the similar size, stage in life cycle or area of specialty. We will continue to apply this process until a sufficient amount of historical
information regarding the volatility of our own stock price becomes available. |
| · | Expected Term. The expected term represents the period that the stock-based awards
are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the
end of the contractual term), as we do not have sufficient historical data to use any other method to estimate expected term. |
| · | Expected Dividend Yield. We have never paid dividends on our Common Stock and have
no plans to pay dividends on our Common Stock. Therefore, we used an expected dividend yield of zero. |
Certain of such assumptions involve inherent
uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and we use significantly
different assumptions or estimates, our stock-based compensation could be materially different.
Common Stock Valuations. Prior
to our initial public offering (“IPO”) in June 2021, there was no public market for our Common Stock, and, as a result, the
fair value of the shares of Common Stock underlying our stock-based awards was estimated on each grant date by our Board. To determine
the fair value of our Common Stock underlying option grants, our Board considered, among other things, input from management, and our
Board’s assessment of additional objective and subjective factors that it believed were relevant, and factors that may have changed
from the date of the most recent valuation through the date of the grant. These factors included, but were not limited to:
| · | our results of operations and financial position, including our levels of available capital resources; |
| · | our stage of development and material risks related to our business; |
| · | progress of our research and development activities; |
| · | our business conditions and projections; |
| · | the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as
recently completed mergers and acquisitions of peer companies; |
| · | the lack of marketability of our Common Stock as a private company; |
| · | the prices at which we sold shares of our Common Stock to outside investors in arms-length transactions; |
| · | the likelihood of achieving a liquidity event for our security holders, such as an IPO or a sale of our
company, given prevailing market conditions; |
| · | trends and developments in our industry; and |
| · | external market conditions affecting the life sciences and biotechnology industry sectors. |
Following the closing of our IPO, our Board
determined the fair market value of our Common Stock based on the closing price of our Common Stock as reported on the date of grant.
Plan of Operations
We intend to develop and commercialize therapeutics
that are better than existing treatments and have the potential to significantly improve the lives of individuals afflicted by Alzheimer’s,
BD, MDD and PTSD. To achieve these goals, we are pursuing the following key business strategies:
| · | Advance clinical development of AL001 for Alzheimer’s, BD, MDD and PTSD treatment; |
| · | Advance clinical development of ALZN002 for Alzheimer’s treatment; |
| · | Expand our pipeline of pharmaceuticals to include additional indications for AL001 and delivery methods; |
| · | Focus on translational and functional endpoints to efficiently develop product candidates; and |
| · | Optimize the value of AL001 and ALZN002 in major markets. |
Our pipeline consists of two novel therapeutic
drug candidates:
| · | AL001 - A patented ionic cocrystal technology delivering a therapeutic combination of lithium, salicylate
and proline through three royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and |
| · | ALZN002 - A patented method using a mutant peptide sensitized cell as a cell-based therapeutic vaccine
that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s through a royalty-bearing exclusive
worldwide license from the Licensor. |
Our most advanced product candidate (lead
product) licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer’s,
BD, MDD and PTSD. Based on our preclinical data involving mice models, AL001 treatment prevented cognitive deficits, depression and irritability
and is superior in improving associative learning and memory and irritability compared with lithium carbonate treatments, supporting the
potential of this lithium formulation for the treatment of Alzheimer’s, BD, MDD and PTSD in humans. Lithium has been marketed for
more than 35 years and human toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden
for safety data.
On May 5, 2022,
we initiated a multiple-dose, steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic clinical trial of AL001
in patients with mild to moderate Alzheimer’s and healthy subjects. We completed the Phase IIA clinical trial patient dosing in
March 2023 and announced positive topline data in June 2023.
We announced that we successfully identified
a maximum tolerated dose (“MTD”) for development of AL001 from a multiple-ascending dose study as assessed by an independent
safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily (“TID”),
is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”). Also, this MTD is risk mitigated for the
purpose of treating fragile populations, such as Alzheimer’s patients.
Lithium is a commonly prescribed drug for
manic episodes in BD type 1 as well as maintenance therapy of BD in patients with a history of manic episodes. Lithium is also prescribed
off-label for MDD, BD and treatment of PTSD, among other disorders. Lithium was the first mood stabilizer approved by the U.S. Food and
Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”) but is
underutilized perhaps because of the need for TDM. Lithium was the first drug that required TDM by regulatory authorities in product labelling
because the effective and safe range of therapeutic drug blood concentrations is narrow and well defined for treatment of BD when using
lithium salts. Excursions above this range can be toxic, and below can impair effectiveness.
Based on the results from our Phase IIA
MAD study, we plan to initiate two safety and efficacy clinical trials in subjects with mild to moderate dementia of the Alzheimer’s
type. Additionally, we are investigating the potential of AL001 for patients suffering from BD, MDD and PTSD, and submitted Investigational
New Drug (“IND”) applications to the FDA for these indications. The IND for BD was filed in August 2023 and we received a
“study may proceed” letter from the FDA in September 2023. The IND for MDD was filed in October 2023 and we received a “study
may proceed” letter from the FDA in November 2023. The IND for PTSD was filed in November 2023. After FDA permission to proceed
on the INDs, we intend to initiate clinical trials at the MTD to determine relative increased lithium levels in the brain compared to
a marketed lithium salt for BD, MDD and PTSD, based on published mouse studies that predict that lithium can be given at lower doses for
equivalent therapeutic benefit when treating with AL001. For example, the goal is to replace a 300 mg TID lithium carbonate dose for treatment
of BD with a 240 mg TID AL001 lithium equivalent, which represents a daily decrease of 20% of lithium given to a patient.
We submitted a pre-IND meeting request for
ALZN002 and supporting briefing documents to the Center for Biological Evaluation and Research of the FDA on July 30, 2021. We received
a written response relating to the pre-IND from the FDA providing a path for Alzamend’s planned clinical development of ALZN002
on September 30, 2021. The FDA agreed to allow Alzamend to submit an IND to conduct a combined Phase I/II study.
On September 28, 2022, we submitted an IND
application to the FDA for ALZN002 and received a “study may proceed” letter on October 31, 2022. The product candidate is
an immunotherapy vaccine designed to treat mild to moderate dementia of the Alzheimer’s type. ALZN002 is a proprietary “active”
immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous DCs that are activated
white blood cells taken from each individual patient so that they can be engineered outside of the body to attack Alzheimer’s-related
amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s
immune system to combat Alzheimer’s; the goal being to foster tolerance to treatment for safety purposes while stimulating the immune
system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms. Compared to
passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with ALZN002
is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid. This could provide a safer approach due to
its reliance on autologous immune components, using each individual patient’s own white blood cells rather than foreign cells and/or
blood products.
On April 3, 2023, we announced the initiation
of a Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia of the Alzheimer’s type. The purpose of this trial
is to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of placebo in 20-30 subjects
with mild to moderate morbidity. The primary goal of this clinical trial is to determine an appropriate dose of ALZN002 for treatment
of patients with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial, which Alzamend expects to initiate within
three months of receiving data from the initial trial.
The continuation of our current plan of
operations with respect to conducting the series of human clinical trials for each of our therapeutics requires us to raise additional
capital to fund our operations.
Because our working capital requirements
depend upon numerous factors, including the progress of our preclinical and clinical testing, timing and cost of obtaining regulatory
approvals, changes in levels of resources that we devote to the development of manufacturing and marketing capabilities, competitive and
technological advances, status of competitors, and our ability to establish collaborative arrangements with other organizations, we will
require additional financing to fund future operations.
On September 26,
2023, we received a notice from the staff of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the previous 30 consecutive
business days, the minimum Market Value of Listed Securities (“MVLS”) for our Common Stock was below the $35 million minimum
MVLS requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(2) (the “MVLS Rule”).
In accordance with Nasdaq Listing Rule 5810(c)(3)(C), we have 180 calendar days, or until March 25, 2024, to regain compliance with the
MVLS Rule. To regain compliance with the MVLS Rule, the MVLS for our Common Stock must close at $35 million or more for a minimum of 10
consecutive business days at any time during this 180-day period. If we regain compliance with the MVLS Rule, Nasdaq will provide us with
written confirmation and will close the matter. If we do not regain compliance with the rule by March 25, 2024, Nasdaq will provide notice
that our Common Stock will be delisted from the Nasdaq Capital Market. In the event of such notification, the Nasdaq rules permit us an
opportunity to appeal Nasdaq’s determination.
Results of Operations
Results of Operations for the Three Months Ended October 31, 2023 and 2022
The following table summarizes the results
of our operations for the three months ended October 31, 2023 and 2022.
| |
For the Three Months Ended October 31, | |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
OPERATING EXPENSES | |
| | |
| | |
| | |
| |
Research and development | |
$ | 1,996,783 | | |
$ | 1,532,985 | | |
$ | 463,798 | | |
| 30 | % |
General and administrative | |
| 904,939 | | |
| 1,573,418 | | |
| (668,479 | ) | |
| -42 | % |
Total operating expenses | |
| 2,901,722 | | |
| 3,106,403 | | |
| (204,681 | ) | |
| -7 | % |
Loss from operations | |
| (2,901,722 | ) | |
| (3,106,403 | ) | |
| 204,681 | | |
| -7 | % |
| |
| | | |
| | | |
| | | |
| | |
OTHER EXPENSE, NET | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (4,311 | ) | |
| (3,588 | ) | |
| (723 | ) | |
| 20 | % |
Total other expense, net | |
| (4,311 | ) | |
| (3,588 | ) | |
| (723 | ) | |
| 20 | % |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (2,906,033 | ) | |
$ | (3,109,991 | ) | |
$ | 203,958 | | |
| -7 | % |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per common share | |
$ | (0.44 | ) | |
$ | (0.48 | ) | |
$ | 0.04 | | |
| * | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted weighted average common shares outstanding | |
| 6,563,784 | | |
| 6,499,230 | | |
| | | |
| | |
Revenue
We
currently have only two product candidates, AL001 and ALZN002. These products are in the clinical stage of development and will require
extensive clinical study, review and evaluation, regulatory review and approval, significant marketing efforts and substantial investment
before either or both of them, and any respective successors, will provide us with any revenue. We did not generate any revenues
during the three months ended October 31, 2023 and 2022, and we do not anticipate that we will generate revenue for the foreseeable future.
Research and Development Expenses
Research and development expenses
for the three months ended October 31, 2023 and 2022 were $2.0 million and $1.5 million, respectively. As reflected in the table below,
research and development expenses primarily consisted of professional fees, clinical trial fees and licenses and fees.
| |
For the Three Months Ended October 31, | |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Professional fees | |
$ | 1,045,212 | | |
$ | 915,861 | | |
$ | 129,351 | | |
| 14 | % |
Clinical trial fees | |
| 794,676 | | |
| 551,771 | | |
| 242,905 | | |
| 44 | % |
Licenses and fees | |
| - | | |
| 50,000 | | |
| (50,000 | ) | |
| -100 | % |
Stock-based compensation | |
| 142,603 | | |
| - | | |
| 142,603 | | |
| * | |
Other research and development expenses | |
| 14,292 | | |
| 15,353 | | |
| (1,061 | ) | |
| -7 | % |
Total research and development expenses | |
$ | 1,996,783 | | |
$ | 1,532,985 | | |
$ | 463,798 | | |
| 30 | % |
* Not meaningful
Professional Fees
During the three months ended October 31,
2023 and 2022, we incurred professional fees of $1.0 million and $900,000, respectively, which were principally comprised of professional
fees attributed to various types of scientific services, including FDA consulting services. The increase relates to higher professional
fees incurred related to IND preparation for the additional indications for AL001.
Clinical Trial Fees
During the three months ended October 31,
2023 and 2022, we incurred clinical trial fees of $795,000 and $552,000, respectively. Clinical trial fees for the three months ended
October 31, 2023, consisted of $455,000 for our Phase IIA clinical trial for AL001 and $340,000 for our Phase IIA clinical trial for ALZN002.
Clinical trial fees for the three months ended October 31, 2022 were for our Phase I clinical trial for AL001.
Licenses and Fees
There are certain initial license fees and
milestone payments required to be paid to the University of South Florida and the Licensor, for the licenses of the technologies, pursuant
to the terms of the License Agreement with Sublicensing Terms.
Stock-Based Compensation Expense
During the three months ended
October 31, 2023, we incurred research and development stock-based compensation of $143,000, related to stock option grants to consultants.
The increase in research and development stock compensation expense for the three months ended October 31, 2023 was a result of the vesting
of performance stock options grants.
Other Research and Development Expenses
During the three months ended October 31,
2023 and 2022, we incurred other fees of $14,000 and $15,000, respectively, which were principally comprised of scientific materials required
for our clinical trials.
General and Administrative Expenses
General and administrative expenses for the three months ended October
31, 2023 and 2022 were $905,000 and $1.6 million, respectively. As reflected in the table below, general and administrative expenses primarily
consisted of the following expense categories: stock-based compensation expense; marketing fees; professional fees; insurance; as well
as salaries and benefits. For the three months ended October 31, 2023 and 2022, the remaining general and administrative expenses of $131,000
and $129,000, respectively, primarily consisted of payments for filing fees, transfer agent fees, travel and entertainment, board of director
fees and other office expenses, none of which is significant individually.
| |
For the Three Months Ended October 31, | |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Stock-based compensation expense | |
$ | 175,733 | | |
$ | 715,639 | | |
$ | (539,906 | ) | |
| -75 | % |
Professional fees | |
| 283,585 | | |
| 133,105 | | |
| 150,480 | | |
| 113 | % |
Insurance | |
| 88,988 | | |
| 129,573 | | |
| (40,585 | ) | |
| -31 | % |
Salary and benefits | |
| 225,934 | | |
| 219,132 | | |
| 6,802 | | |
| 3 | % |
Marketing fees | |
| - | | |
| 247,334 | | |
| (247,334 | ) | |
| -100 | % |
Other general and administrative expenses | |
| 130,699 | | |
| 128,635 | | |
| 2,064 | | |
| 2 | % |
Total general and administrative expenses | |
$ | 904,939 | | |
$ | 1,573,418 | | |
$ | (668,479 | ) | |
| -42 | % |
Stock-Based Compensation Expense
During the three months ended
October 31, 2023 and 2022, we incurred general and administrative stock-based compensation expense of $175,733 and $716,000, respectively,
related to stock option grants and restricted stock grants to executives, employees and consultants. The decrease in stock-based compensation
for the three months ended October 31, 2023 was a result of fewer stock options vesting during the period compared to the prior year.
Professional Fees
During the three months ended October 31,
2023 and 2022, we incurred professional fees of $284,000 and $133,000, respectively, which were principally comprised of the following
items:
Three Months Ended October 31, 2023
| · | During the three months ended October 31, 2023, we incurred $92,000 in audit fees, $89,000 in investor
relations, $67,000 in legal fees, $13,000 in tax preparation fees, $12,000 in related party consulting and $11,000 in Sarbanes-Oxley compliance
fees. |
Three Months Ended October 31, 2022
| · | During the three months ended October 31, 2022, we recorded an expense of $70,000 in connection with the
five-year consulting agreement with Spartan Capital; and |
| · | During the three months ended October 31, 2022, we incurred $20,000 in audit fees, $13,000 in related
party consulting, $11,000 in Sarbanes-Oxley compliance fees, $7,000 in tax preparation fees and $12,000 in other professional fees. |
Insurance Expense
During the three months ended October 31,
2023 and 2022, we incurred insurance expense of $89,000 and $130,000, respectively, which was primarily directors’ and officers’
insurance.
Salaries and Benefits
During the three months ended October 31,
2023 and 2022, we incurred $226,000 and $219,000, respectively, in employee-related expenses. As of October 31, 2023, we had four full-time
and three part-time employees.
Marketing Fees
During the three months ended October 31,
2022, we incurred marketing fees of $247,000, which was primarily expenses related to the marketing and brand development agreement with
Ault Alliance, Inc. (“AAI”), a related party.
Results of Operations for the Six Months Ended October 31, 2023 and 2022
The following table summarizes the results
of our operations for the six months ended October 31, 2023 and 2022.
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
OPERATING EXPENSES | |
| | |
| | |
| | |
| |
Research and development | |
$ | 4,362,920 | | |
$ | 2,908,940 | | |
$ | 1,453,980 | | |
| 50 | % |
General and administrative | |
| 2,064,732 | | |
| 3,233,005 | | |
| (1,168,273 | ) | |
| -36 | % |
Total operating expenses | |
| 6,427,652 | | |
| 6,141,945 | | |
| 285,707 | | |
| 5 | % |
Loss from operations | |
| (6,427,652 | ) | |
| (6,141,945 | ) | |
| (285,707 | | |
| 5 | % |
| |
| | | |
| | | |
| | | |
| | |
OTHER EXPENSE, NET | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (6,147 | ) | |
| (5,120 | ) | |
| (1,027 | ) | |
| 20 | % |
Total other expense, net | |
| (6,147 | ) | |
| (5,120 | ) | |
| (1,027 | ) | |
| 20 | % |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
$ | (6,433,799 | ) | |
$ | (6,147,065 | ) | |
$ | (286,734 | ) | |
| 5 | % |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per common share | |
$ | (0.98 | ) | |
$ | (0.95 | ) | |
$ | (0.03 | ) | |
| * | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted weighted average common shares outstanding | |
| 6,563,230 | | |
| 6,499,008 | | |
| | | |
| | |
Revenue
We
currently have only two product candidates, AL001 and ALZN002. These products are in the clinical stage of development and will require
extensive clinical study, review and evaluation, regulatory review and approval, significant marketing efforts and substantial investment
before either or both of them, and any respective successors, will provide us with any revenue. We did not generate any revenues
during the six months ended October 31, 2023 and 2022, and we do not anticipate that we will generate revenue for the foreseeable future.
Research and Development Expenses
Research and development expenses
for the six months ended October 31, 2023 and 2022 were $4.4 million and $2.9 million, respectively. As reflected in the table below,
research and development expenses primarily consisted of professional fees, clinical trial fees and licenses and fees.
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Professional fees | |
$ | 2,114,802 | | |
$ | 2,109,035 | | |
$ | 5,768 | | |
| 0 | % |
Clinical trials | |
| 2,039,794 | | |
| 575,271 | | |
| 1,464,523 | | |
| 255 | % |
Licenses and fees | |
| - | | |
| 55,000 | | |
| (55,000 | ) | |
| -100 | % |
Stock-based compensation | |
| 142,603 | | |
| - | | |
| 142,603 | | |
| * | |
Other research and development expenses | |
| 65,721 | | |
| 169,634 | | |
| (103,914 | ) | |
| -61 | % |
Total research and development expenses | |
$ | 4,362,920 | | |
$ | 2,908,940 | | |
$ | 1,453,980 | | |
| 50 | % |
* Not meaningful
Professional Fees
During each of the six months ended October
31, 2023 and 2022, we incurred professional fees of $2.1 million, which were principally comprised of professional fees attributed to
various types of scientific services, including FDA consulting services.
Clinical Trial Fees
During the six months ended October 31,
2023 and 2022, we incurred clinical trial fees of $2.0 million and $575,000, respectively. Clinical trial fees for the six months ended
October 31, 2023 consisted of $1.4 million for our Phase IIA clinical trial for AL001 and $650,000 for our Phase IIA clinical trial for
ALZN002. Clinical trial fees for the six months ended October 31, 2022 were for our Phase I clinical trial for AL001.
Licenses and Fees
There are certain initial license fees and
milestone payments required to be paid to the University of South Florida and the Licensor, for the licenses of the technologies, pursuant
to the terms of the License Agreement with Sublicensing Terms.
Stock-Based Compensation Expense
During the six months ended
October 31, 2023, we incurred research and development stock-based compensation of $143,000, related to stock option grants to consultants.
The increase in research and development stock compensation expense for the six months ended October 31, 2023 was a result of the vesting
of performance stock options grants
Other Research and Development Expenses
During the six months ended October 31,
2023 and 2022, we incurred other fees of $66,000 and $170,000, respectively, which were principally comprised of scientific materials
required for our clinical trials.
General and Administrative Expenses
General and administrative
expenses for the six months ended October 31, 2023 and 2022 were $2.1 million and $3.2 million, respectively. As reflected in the table
below, general and administrative expenses primarily consisted of the following expense categories: stock-based compensation expense;
marketing fees; professional fees; insurance; as well as salaries and benefits. For the six months ended October 31, 2023 and 2022, the
remaining general and administrative expenses of $252,000 and $257,000, respectively, primarily consisted of payments for filing fees,
transfer agent fees, travel and entertainment, board of director fees and other office expenses, none of which is significant individually.
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | | |
$ Change | | |
% Change | |
Stock-based compensation expense | |
$ | 545,113 | | |
$ | 1,582,978 | | |
$ | (1,037,865 | ) | |
| -66 | % |
Professional fees | |
| 434,764 | | |
| 376,505 | | |
| 58,259 | | |
| 15 | % |
Insurance | |
| 206,684 | | |
| 326,000 | | |
| (119,316 | ) | |
| -37 | % |
Salary and benefits | |
| 379,258 | | |
| 442,909 | | |
| (63,651 | ) | |
| -14 | % |
Marketing fees | |
| 247,334 | | |
| 247,934 | | |
| (600 | ) | |
| 0 | % |
Other general and administrative expenses | |
| 251,579 | | |
| 256,679 | | |
| (5,100 | ) | |
| -2 | % |
Total general and administrative expenses | |
$ | 2,064,732 | | |
$ | 3,233,005 | | |
$ | (1,168,273 | ) | |
| -36 | % |
Stock-Based Compensation Expense
During the six months ended
October 31, 2023 and 2022, we incurred general and administrative stock-based compensation expense of $545,000 and $1.6 million, respectively,
related to stock option grants and restricted stock grants to executives, employees and consultants. The decrease in stock-based compensation
for the six months ended October 31, 2023 was a result of fewer stock options vesting during the period compared to the prior year.
Professional Fees
During the six months ended October 31,
2023 and 2022, we incurred professional fees of $435,000 and $376,000, respectively, which were principally comprised of the following
items:
Six Months Ended October 31, 2023
| · | During the six months ended October 31, 2023, we incurred $170,000 in audit fees, $118,000 in investor
relations, $69,000 in legal fees, $29,000 in tax preparation fees, $24,000 in related party consulting, $17,000 in Sarbanes-Oxley compliance
fees and $8,000 in other professional fees. |
Six Months Ended October 31, 2022
| · | During the six months ended October 31, 2022, we recorded an expense of $140,000 in connection with the
five-year consulting agreement with Spartan Capital; and |
| · | During the six months ended October 31, 2022, we incurred $100,000 in audit fees, $41,000 in Sarbanes-Oxley
compliance fees, $25,000 in related party consulting, $25,000 in tax preparation fees and $43,000 in other professional fees. |
Insurance Expense
During the six months ended October 31,
2023 and 2022, we incurred insurance expense of $207,000 and $326,000, respectively, which was primarily directors’ and officers’
insurance.
Salaries and Benefits
During the six months ended October 31,
2023 and 2022, we incurred $379,000 and $443,000, respectively, in employee-related expenses. As of October 31, 2023, we had four full-time
and three part-time employees.
Marketing Fees
During the six months ended October 31,
2023 and 2022, we incurred marketing fees of $247,000 and $248,000, respectively, which was primarily expenses related to the marketing
and brand development agreement with AAI, a related party.
Liquidity and Capital Resources
The accompanying condensed financial statements have been prepared
assuming that we will continue as a going concern. We have incurred recurring net losses and operations have not provided sufficient cash
flows. We believe that we will continue to incur operating and net losses each quarter until at least the time we are able to generate
revenues from operations. We believe our current cash on hand is insufficient to fund our planned
operations through one year after the date the condensed financial statements are issued. These factors create substantial doubt about
our ability to continue as a going concern for at least one year after the date that our condensed financial statements are issued.
Our inability to continue as a going concern could have
a negative impact on our company, including our ability to obtain needed financing. We intend to finance our
future development activities and our working capital needs largely through the sale of equity securities with some additional funding
from other sources, including debt financing, until such time as funds provided by operations are sufficient to fund working capital requirements.
Our condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded assets,
or the amounts and classifications of liabilities that might be necessary should we be unable to continue as a going concern. As of October
31, 2023, we had cash of $200,000, an accumulated deficit of $50.5 million and stockholders’ deficit of $2.7 million. We have incurred
recurring losses and reported losses for the three and six months ended October 31, 2023 totaling $2.9 million and $6.4 million, respectively.
In the past, we have financed our operations principally through sales of equity securities and debt instruments.
We will need to obtain substantial additional
funding in the future for our clinical development activities and continuing operations. If we are unable to raise capital when needed
or on favorable terms, we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization
efforts. Our future capital requirements will depend on many factors, including:
| · | successful enrollment in and completion of clinical trials; |
| · | our ability to establish agreements with third-party manufacturers for clinical supply for our clinical
trials and, if our product candidates are approved, commercial manufacturing; |
| · | our ability to maintain our current research and development programs and establish new research and development
programs; |
| · | addition and retention of key research and development personnel; |
| · | our efforts to enhance operational, financial, and information management systems, and hire additional
personnel, including personnel to support development of our product candidates; |
| · | negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter
and performing our obligations in such collaborations; |
| · | the timing and amount of milestone and other payments we may receive under our collaboration arrangements; |
| · | our eventual commercialization plans for our product candidates; |
| · | the costs involved in prosecuting, defending, and enforcing patent claims and other intellectual property
claims; and |
| · | the costs and timing of regulatory approvals. |
A change in the outcome of any of these
or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated
with the development of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional
funds to meet operational needs and capital requirements associated with such operating plans.
On September 8, 2023, we entered into an
At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC, as sales agent to sell shares of our Common stock, having
an aggregate offering price of up to approximately $9.8 million (the “Shares”) from time to time, through an “at the
market offering” (the “ATM Offering”) as defined in Rule 415 under the Securities Act. On September 8, 2023, we filed
a prospectus supplement with the SEC relating to the offer and sale of up to approximately $9.8 million in shares of Common Stock in the
ATM Offering.
During the six months ended October 31, 2023, we sold an aggregate
of 6,149 shares of Common Stock pursuant to the ATM Offering for gross proceeds of $19,000. During
the period between November 1, 2023 through December 14, 2023, we sold an aggregate of 651,046 shares of Common Stock pursuant to
the ATM Offering for gross proceeds of $849,000.
Cash Flows
The following table summarizes our cash
flows for the six months ended October 31, 2023 and 2022:
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | |
Net cash provided by (used in): | |
| | |
| |
Operating activities | |
$ | (4,811,624 | ) | |
$ | (4,880,999 | ) |
Investing activities | |
| (147,243 | ) | |
| - | |
Financing activities | |
| 18,087 | | |
| - | |
Net decrease in cash and cash equivalents | |
$ | (4,940,780 | ) | |
$ | (4,880,999 | ) |
Operating Activities
During the six months ended
October 31, 2023, net cash used in operating activities was $4.8 million. This consisted primarily of a net loss of $6.4 million partially
offset by an increase in our net operating assets and liabilities of $909,000 and non-cash charges of $714,000. The non-cash charges primarily
consisted of stock-based compensation expense. The increase in our net operating assets and liabilities was due to an increase in accounts
payable and accrued liabilities, an increase in prepaid expenses and other current assets and a decrease in prepaid expenses - related
party.
Investing Activities
During the six months ended October 31,
2023, net cash used in investing activities was $147,000 from the purchase of machinery and equipment. We purchased equipment, which draws
blood from patients and separates the monocytes from their blood, to be used in the ALZN002 clinical trial.
Financing Activities
During the six months ended October 31,
2023, net cash provided by financing activities was $18,000 from proceeds from the ATM Offering.
Contractual Obligations
On July 2, 2018, we entered
into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and its affiliate, the University of
South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses
limited to the field of Alzheimer’s, under United States Patent Nos. (i) 9,840,521, entitled “Organic Anion Lithium Ionic
Cocrystal Compounds and Compositions”, filed September 24, 2015 and granted December 12, 2017, and (ii) 9,603,869, entitled “Lithium
Co-Crystals for Treatment of Neuropsychiatric Disorders”, filed May 21, 2016 and granted March 28, 2017. On February 1, 2019, we
entered into the First Amendments to the AL001 Licenses, on March 30, 2021, we entered into the Second Amendments to the AL001 Licenses
and on June 8, 2023, we entered into the Third Amendments to the AL001 Licenses (collectively, the “AL001 License Agreements”).
The Third Amendments to the AL001 Licenses modified the timing of the payments for the license fees.
The AL001 License Agreements require that
we pay combined royalty payments of 4.5% on net sales of products developed from the licensed technology for AL001. We have already paid
an initial license fee of $200,000 for AL001. As an additional licensing fee for the license of the AL001 technologies, the Licensor received
148,528 shares of our common stock. Minimum royalties for AL001 License Agreements are $40,000 on the first anniversary of the first commercial
sale, $80,000 on the second anniversary of the first commercial sale and $100,000 on the third anniversary of the first commercial sale
and every year thereafter, for the life of the AL001 License Agreements.
On May 1, 2016, we entered into a Standard Exclusive License Agreement
with Sublicensing Terms for ALZN002 with the Licensor (the “ALZN002 License”), pursuant to which the Licensor granted us a
royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy and Diagnostics, under United States
Patent No. 8,188,046, entitled “Amyloid Beta Peptides and Methods of Use”, filed April 7, 2009 and granted May 29, 2012. On
August 18, 2017, we entered into the First Amendment to the ALZN002 License, on May 7, 2018, we entered into the Second Amendment to the
ALZN002 License, on January 31, 2019, we entered into the Third Amendment to the ALZN002 License, on January 24, 2020, we entered into
the Fourth Amendment to the ALZN002 License, on March 30, 2021, we entered into the Fifth Amendment to the ALZN002 License, on April 17,
2023, we entered into the Sixth Amendment to the ALZN002 License and on December 11, 2023, we entered into the Seventh Amendment to the
ALZN002 License (collectively, the “ALZN002 License Agreement”). The Seventh Amendment to the ALZN002 License modified the
timing of the payments for the license fees.
The ALZN002 License Agreement requires us
to pay royalty payments of 4% on net sales of products developed from the licensed technology for ALZN002. We have already paid an initial
license fee of $200,000 for ALZN002. As an additional licensing fee for the license of ALZN002, the Licensor received 240,120 shares of
our common stock. Minimum royalties for ALZN002 are $20,000 on the first anniversary of the first commercial sale, $40,000 on the second
anniversary of the first commercial sale and $50,000 on the third anniversary of the first commercial sale and every year thereafter,
for the life of the ALZN002 License Agreement.
On November 19, 2019, we entered
into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications of AL001 with the Licensor (the
“November AL001 License”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses limited
to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric diseases and disorders. On March 30,
2021, we entered into the First Amendments to the November AL001 License and on April 17, 2023, we entered into the Second Amendments
to the November AL001 License (collectively, the “November AL001 License Agreements”). The Second Amendments to the November
AL001 License modified the timing of the payments for the license fees.
The November AL001 License Agreements require
us to pay royalty payments of 3% on net sales of products developed from the licensed technology for AL001 in those fields. We paid an
initial license fee of $20,000 for the additional indications. Minimum royalties for November AL001 License Agreements are $40,000 on
the first anniversary of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and $100,000 on the
third anniversary of the first commercial sale and every year thereafter, for the life of the November AL001 License Agreements.
These license agreements have an indefinite
term that continue until the later of the date no licensed patent under the applicable agreement remains a pending application or enforceable
patent, the end date of any period of market exclusivity granted by a governmental regulatory body, or the date on which the licensee’s
obligations to pay royalties expire under the applicable license agreement. Under our various license agreements, if we fail to meet a
milestone by its specified date, Licensor may terminate the license agreement. The Licensor was also granted a preemptive right to acquire
such shares or other equity securities that may be issued from time to time by us while the Licensor remains the owner of any equity securities
of our company.
Additionally, we are required to pay milestone
payments on the due dates to the Licensor for the license of the AL001 technologies and for the ALZN002 technology, as follows:
Original AL001 Licenses:
Payment | |
Due Date | |
Event |
$ | 50,000 | * |
Completed September 2019 | |
Pre-IND meeting |
| | |
| |
|
$ | 65,000 | * |
Completed June 2021 | |
IND application filing |
| | |
| |
|
$ | 190,000 | * |
Completed December 2021 | |
Upon first dosing of patient in a clinical trial |
| | |
| |
|
$ | 500,000 | * |
Completed March 2022 | |
Upon completion of first clinical trial |
| | |
| |
|
$ | 1,250,000 | |
March 2025 | |
Upon first patient treated in a Phase III clinical trial |
| | |
| |
|
$ | 10,000,000 | |
8 years from the effective date of the agreement | |
Upon FDA NDA approval |
| * | Milestone met and completed |
ALZN002 License:
Payment | |
Due Date |
$ | 50,000 | * |
Upon IND application - completed January 2022 |
| | |
|
$ | 50,000 | |
Upon first dosing of patient in first Phase I clinical trial |
| | |
|
$ | 500,000 | |
Upon completion of first Phase IIb clinical trial |
| | |
|
$ | 1,000,000 | |
Upon first patient treated in a Phase III clinical trial |
| | |
|
$ | 10,000,000 | |
Upon fist commercial sale |
| * | Milestone met and completed |
Additional AL001 Licenses:
Payment | |
Due Date | |
Event |
$ | 2,000,000 | |
March 2026 | |
Upon first patient treated in a Phase III clinical trial |
| | |
| |
|
$ | 16,000,000 | |
August 1, 2029 | |
First commercial sale |
Off-Balance Sheet Arrangements
We do not have any 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 is material to investors.
Recent Accounting Standards
None.
| ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
Because we are a smaller reporting company,
this section is not applicable.
| ITEM 4. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls
and Procedures
We have established disclosure controls
and procedures designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act
is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and is accumulated and communicated
to management, including the principal executive officer and principal financial officer, to allow timely decisions regarding required
disclosure.
Our principal executive officer and principal
financial officer, with the assistance of other members of the Company’s management, have evaluated the effectiveness of the design
and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act)
as of the end of the period covered by this quarterly report. Based upon our evaluation, each of our principal executive officer and principal
financial officer has concluded that the Company’s internal control over financial reporting was not effective as of the end of
the period covered by this Quarterly Report on Form 10-Q because the Company has not yet completed its remediation of the material weakness
previously identified and disclosed in the Company’s Annual Report on Form 10-K for the year ended April 30, 2023, the end of its
most recent fiscal year.
Specifically, management has identified
the following material weaknesses:
| 1. | we do not have sufficient resources in our accounting function, which
restricts our ability to perform sufficient reviews and approval of manual journal entries posted to the general ledger and to consistently
execute review procedures over general ledger account reconciliations, financial statement preparation and accounting for non-routine
transactions; and |
| 2. | our primary user access controls (i.e., provisioning, de-provisioning,
privileged access and user access reviews) to ensure appropriate authorization and segregation of duties that would adequately restrict
user and privileged access to the financially relevant systems and data to appropriate personnel were not designed and/or implemented
effectively. We did not design and/or implement sufficient controls for program change management to certain financially relevant systems
affecting our processes. |
A material weakness is a control deficiency
or combination of control deficiencies that result in more than a remote likelihood that a material misstatement of the annual or interim
financial statements will not be prevented or detected.
Planned Remediation
We are implementing measures designed to
improve our internal control over financial reporting to remediate material weaknesses, including the following:
| · | Formalizing our internal control documentation and strengthening supervisory reviews by our management;
and |
| · | Adding additional accounting personnel and segregating duties amongst accounting personnel. |
Management continues to work to improve
its controls related to our material weaknesses, specifically relating to user access and change management surrounding our information
technology systems and applications. Management will continue to implement measures to remediate material weaknesses, such that these
controls are designed, implemented, and operating effectively. The remediation actions include: (i) enhancing design and documentation
related to both user access and change management processes and control activities; and (ii) developing and communicating additional policies
and procedures to govern the area of information technology change management. In order to achieve the timely implementation of the above,
management has commenced the following actions and will continue to assess additional opportunities for remediation on an ongoing basis:
| · | Engaging a third-party specialist to assist management with improving the Company’s overall control
environment, focusing on change management and access controls; and |
| · | Implementing new applications and systems that are aligned with management’s focus on creating strong
internal controls. |
We are currently working to improve and
simplify our internal processes and implement enhanced controls, as discussed above, to address the material weaknesses in our internal
control over financial reporting and to remedy the ineffectiveness of our disclosure controls and procedures. These material weaknesses
will not be considered to be remediated until the applicable remediated controls are operating for a sufficient period of time and management
has concluded, through testing, that these controls are operating effectively.
Despite the existence of these material
weaknesses, we believe that the condensed financial statements included in the period covered by this Quarterly Report on Form 10-Q fairly
present, in all material respects, our financial condition, results of operations and cash flows for the periods presented in conformity
with U.S. generally accepted accounting principles.
Changes in Internal Control
Except as detailed above, during the quarter
ended October 31, 2023, there was no change in our internal control over financial reporting that materially affected, or is reasonably
likely to materially affect, our internal control over financial reporting.
PART II — OTHER INFORMATION
From time to time, we may be subject to
legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or in the aggregate,
a material adverse effect on our business, financial condition or results of operations. Regardless of outcome, litigation can have an
adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
The risks described in Part I, Item 1A,
“Risk Factors,” in our 2023 Annual Report on Form 10-K, could materially and adversely affect our business, financial condition
and results of operations, and the trading price of our Common Stock could decline. These risk factors do not identify all risks that
we face - our operations could also be affected by factors that are not presently known to us or that we currently consider to be immaterial
to our operations. Due to risks and uncertainties, known and unknown, our past financial results may not be a reliable indicator of future
performance and historical trends should not be used to anticipate results or trends in future periods. The Risk Factors section of our 2023 Annual
Report on Form 10-K remains current in all material respects.
| ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES, USE OF PROCEEDS, AND ISSUER PURCHASES OF EQUITY SECURITIES |
None.
| ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None.
| ITEM 4. | MINE SAFETY DISCLOSURES |
Not applicable.
None.
Exhibit
No. |
|
Exhibit Description |
3.1 |
|
Certificate of Incorporation (incorporated by reference to Exhibit 2.1 of Form DOS filed with the SEC on August 19, 2016). |
3.2* |
|
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on June 10, 2016. |
3.3* |
|
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on December 22, 2020. |
3.4 |
|
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on October 27, 2023 (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K filed with the SEC on October 30, 2023). |
3.5 |
|
Certificate of Designation of Alzamend Neuro, Inc. Series A Convertible Preferred Stock, dated May 30, 2016 (incorporated by reference to Exhibit 2.3 of Form 1-A/A filed with the SEC on February 4, 2020). |
3.6 |
|
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the registration statement on Form S-1 filed with the SEC on May 10, 2021). |
10.1 |
|
At-The-Market Issuance Sales Agreement, dated September 8, 2023, with Ascendiant Capital Markets, LLC (incorporated by reference to Exhibit 10.1 of the Current Report on Form 8-K filed with the SEC on September 8, 2023). |
10.2* |
|
Form of Amendment to Standard Exclusive License Agreement with Sublicensing Terms Number LIC16118 with University of South Florida Research Foundation, Inc., dated December 11, 2023. |
31.1* |
|
Certification of Chief Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a). |
31.2* |
|
Certification of Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a). |
32.1** |
|
Certification of Chief Executive and Financial Officer required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code. |
101.INS* |
|
XBRL Instance Document. The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
101.SCH* |
|
Inline XBRL Taxonomy Extension Schema Document. |
101.CAL* |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
101.DEF* |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document. |
101.LAB* |
|
Inline XBRL Taxonomy Extension Label Linkbase Document. |
101.PRE* |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
*Filed herewith.
** This certification will not be deemed “filed”
for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section. Such certification will not be
deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the
extent specifically incorporated by reference into such filing.
SIGNATURES
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.
|
ALZAMEND NEURO, INC. |
|
|
|
|
Date: December 15, 2023 |
By: |
|
/s/ Stephan Jackman
Stephan Jackman
Chief Executive Officer (principal executive officer) |
Date: December 15, 2023 |
By: |
|
/s/ David J. Katzoff
David J. Katzoff
Chief Financial Officer (principal financial and accounting officer) |
36
Exhibit 3.2
Delaware Page 1 The First State I, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF AMENDMENT OF "ALZAMEND NEURO, INC. ", FILED IN THIS OFFICE ON THE TENTH DAY OF JUNE, A. D. 2016, AT 4:36 O'CLOCK P.M. A FILED COPY OF THIS CERTIFICATE HAS BEEN FORWARDED TO THE NEW CASTLE COUNTY RECORDER OF DEEDS. 5976073 8100 SR# 20164412054 You may verify this certificate online at corp.delaware.gov/authver.shtml Authentication: 2024 73970 Date: 06-10-16
State of Delaware Secretary of State DMslon of Corporations . Deli"ered 04:36 PM 06/1012016 FILED 04:36 PM 06/1012016 STATE OF DELAVARE CERTIFICATE OF AMENDMENT SR 20164412054 ? File~umber 5976073 OF CERTIFICATE OF INCORPORATION The corporation organized and existing m1der and by virtue of the General Corporation Law of the State of Delaware does hereby certify: FIRST: That the Board of Directors of Alza,mend Neuro, Inc. duly adopted, by unanimous vlritten consent pursuant to Sectio11 l41{f) of the General Corporation Law of the State of Delaivare, a resolution setting forth a proposed amendment of the Certificate of Incorporation of said corporation, declaring said amendment to be advisable and recommending said amendment to the stockholders of said corporation for consideration thereof. The resolution setting forth the proposed amendment is as follows: RESOLVED, that the Certificate of Incorporation of this corporation be amended by changing the Fourth Article thereof so that, as amended, said Article shall be and read as follows: FOURTH: The Corporation is authorized to issue two classes of stock to be designated, respectively, "Common Stock" and "Preferred Stock." The total number of shares which the Corporation is authorized to issue is 310,000,000 shares. 300,000,000 shares shall be Common Stock, each having a par value of $0.0001. 10,000,000 shares shall be Preferred Stock, each having a par value of $0,0001. The Preferred Stock may be issued from time to time in one or more series. The Board of Directors is hereby expressly authorized to provide for the issue of all or any of the shares of the Preferred Stock in one or more series, and to fix the number of shares and to det2rmine or alter for each such series, such voting powers, full or limited, or no voting powers, a.nd such designation, preferences, and relative, participating, optional, or other rights and such qualifications, limitations, or restrictions thereof, as shall be stated and expressed in the resolution or resolutions adopted by the Board of Directors providing for the issuance of such shares and as may be permitted by the DGCL. The Board of Directors is also expressly authorized to increase or decrease the number of shares of any series subsequent to the issuance of shares of that series, but not below the number of shares of such series then outstanding. In case the number of shares of any series shall be decreased in accordance with the foregoing sentence, the shares constituting such decrease shall resume the status that they had prior to the adoption of the resolution originally fixing the number of shares of such series. SECOND: That thereafter, in accordance with Section 228 of the General Corporation Law of the State of Delaware, shareholders of the corporation holding the necessary number of shares as required by statute adopted and approved the amendment by written consent. THIRD: That said amendment was duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware.
IN WITNESS WHEREOF, said corporation has caused this certificate to be signed this 27th day of May, 2016. Philip E. Mansour President and CEO
Exhibit 3.3
DelawareThe First StatePage 1 5976073 8100Authentication: 204437303SR# 20208738716Date: 12-29-20You may verify this certificate online at corp.delaware.gov/authver.shtmlI, JEFFREY W. BULLOCK, SECRETARY OF STATE OF THE STATE OF DELAWARE, DO HEREBY CERTIFY THE ATTACHED IS A TRUE AND CORRECT COPY OF THE CERTIFICATE OF AMENDMENT OF "ALZAMEND NEURO, INC.", FILED IN THIS OFFICE ON THE TWENTY-SECOND DAY OF DECEMBER, A.D. 2020, AT 10:21 O`CLOCK P.M.
STATE OF DELAWARE CERTIFICATE OF AMENDMENT OF CERTIFICATE OF INCORPORATION Alzamend Neuro, Inc., a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware (the "Corporation"), does hereby certify: FIRST: That the Board of Directors of the Corporation (the "Board") duly adopted, by unanimous written consent pursuant to Section 141 (f) of the General Corporation Law of the State of Delaware, a resolution setting forth a proposed amendment of the Certificate of Incorporation of said corporation, declaring said amendment to be advisable and recommending said amendment to the stockholders of the Corporation for consideration thereof. SECOND: That, in accordance with the unanimous written consent of the Board, the Fourth Article of the Corporation's Certificate oflncorporation is hereby amended by adding the following section to the end of the Fourth Article to read as follows, subject to compliance with applicable law: "On June 28, 2018 (the "Effective Date"), the issued shares of Common Stock, with a par value of $0.0001 per share ("Old Common Stock"), outstanding or held as treasury shares as of the close of business on the Effective Date, shall automatically without any action on the part of the holders of the Old Common Stock be reverse split (the "Split") on a one-for-four basis so that four (4) shares of Old Common Stock shall be converted into and reconstituted as one (1) share of Common Stock, with a par value of$0.000I per share ("New Common Stock"). In lieu of issuing fractional shares as a result of the Reverse Split, the Corporation will round up to the next whole share of the Common Stock. Each holder of a certificate or certificates which immediately prior to the Effective Date represented outstanding shares of Old Common Stock (the "Old Certificates") shall, from and after the Effective Date, be entitled to receive a certificate or certificates (the "New Certificates") representing the shares of New Common Stock into which the shares of Old Common Stock formerly represented by such Old Certificates are reclassified under the terms hereof. Until surrender, each Old Certificate will continue to be valid and represent New Common Stock equal to one-fourth the number of shares of Old Common Stock including any fractional shares. Prior to the Effective Date, there are 197,114,804 issued and outstanding shares of Old Common Stock and 102,885,196 authorized but unissued shares of Common Stock. On the Effective Date, there will be 49,278,701 issued and outstanding shares of New Common Stock and 250,721,299 authorized but unissued shares ofNew Common Stock. The 197,114,804 shares of Old Common Stock are hereby changed into 49,278,701 shares ofNew Common Stock at the rate of one-for-four." THIRD: That, thereafter, in accordance with Section 228 of the General Corporation Law of the State of Delaware, shareholders of the Corporation holding the necessary number of shares as required by statute adopted and approved the amendment by written consent. FOURTH: That said amendment was duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware. FIFTH: That said amendment is effective as of June 18, 2018 for accounting purposes only. IN WITNESS WHEREOF, said Corporation has caused this Certificate of Amendment to be signed this 22nd day of December 2020. State of Delaware Secretary of State Division of Corporations Delivered 10:21 PM 12/22/2020 FILED 10:21 PM 12/22/2020 SR 20208738716 -File Number 5976073 Isl Stephan Jackman Stephan Jackman, Chief Executive Officer
Exhibit 10.2
Page 1 of 2 SEVENTH AMENDMENT TO LICENSE AGREEMENT Agreement # LIC16118 This Seventh Amendment, is made and entered into on the 11th day of December, 2023 ("Effective Date"), by and between the UNIVERSITY OF SOUTH FLORIDA RESEARCH FOUNDATION, INC. (hereinafter referred to as "Licensor"), a corporation not for profit under Chapter 617 Florida Statutes, and a direct support organization of the University of South Florida pursuant to section 1004.28 Florida Statutes, and Alzamend Neuro, Inc., classified as a corporation organized and existing under the laws of Delaware (hereinafter referred to as "Licensee"). WHEREAS, on May 1, 2016, Licensor and Licensee entered in a license agreement relating to the utilization of Patent Rights ("License Agreement associated with USF Technology referenced as 09A021_Cao; WHEREAS, a Sixth Amendment to the License Agreement was made effective April 17, 2023; and WHEREAS, the parties desire to further amend the License Agreement in this Seventh Amendment to the License Agreement. NOW, THEREFORE, the parties agree as follows: Capitalized terms in this Seventh Amendment shall have the same meaning as set forth in the License Agreement, unless defined otherwise in this Seventh Amendment. All other terms and conditions of the License Agreement shall continue in full force and effect. This Seventh Amendment, together with the License Agreement constitutes the entire agreement between the parties hereto regarding the subject matter hereof and supersedes any prior and/or contemporaneous agreement(s), understanding(s) and/or negotiation(s). 1. Section 4.4.2 is deleted in its entirety and replaced with the following: 4.4.2 In addition to all other payments required under this License Agreement, Licensee agrees to pay Licensor milestone payments, as follows: Payment Due Date $50,000.00 Upon first dosing of patient in first Phase I Clinical Trial $500,000.00 $1,000,000.00 Upon Completion of first Phase IIb Clinical Trial Upon first patient treated in a Phase III Clinical Trial
Page 2 of 2 Sublicenses. In respect to Sublicenses granted by Licensee under 2.2.1 above, Licensee shall pay to Licensor an amount equal to what Licensee would have been required to pay to Licensor had Licensee sold the amount of Licensed Product or Licensed Process sold by such Sublicensee. In addition, if Licensee receives any fees, minimum royalties, milestone payments, or other payments arising from the Sublicense, and such payments are not earned royalties as defined in Section 4.3 above, then Licensee shall pay Licensor fifty percent (50%) of such payments within thirty (30) days of receipt thereof. Such payments shall not be allocated, off-set or otherwise reduced as a result of including rights other than those licensed hereunder in such permitted written Sublicense. Licensee shall not receive from Sublicensees anything of value in lieu of cash payments in consideration arising from any Sublicense under this Agreement without the express prior written permission of Licensor. IN WITNESS WHEREOF, the parties have set their hands and seals and duly executed this Sixth Amendment as of the Effective Date identified in the preamble above. $10,000,000.00 Upon First Commercial Sale UNIVERSITY OF SOUTH FLORIDA RESEARCH FOUNDATION, INC. ALZAMEND NEURO, INC. _______________________________________ ___________________________________ Michele Tyrpak J.D. Stephan Jackman Director, Technology Transfer Office CEO Date:___________________________________ Date:_______________________________ 12 / 11 / 2023
EXHIBIT 31.1
CERTIFICATION
I, Stephan Jackman, certify that:
1. I have reviewed
this quarterly report on Form 10-Q of Alzamend Neuro, Inc.;
2. Based on my
knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
3. Based on my
knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s
other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
(a) Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal
control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness
of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report
any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s
other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
(a) All significant deficiencies
and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or
not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Dated: December 15, 2023
/s/ Stephan Jackman |
|
Name: Stephan Jackman |
|
Title: Chief Executive Officer |
|
(Principal Executive Officer) |
|
EXHIBIT 31.2
CERTIFICATION
I, David J. Katzoff, certify that:
1. I have reviewed
this quarterly report on Form 10-Q of Alzamend Neuro, Inc.;
2. Based on my
knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
3. Based on my
knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s
other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
(a) Designed such disclosure
controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities,
particularly during the period in which this report is being prepared;
(b) Designed such internal
control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes
in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness
of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the
disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report
any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s
other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
(a) All significant deficiencies
and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or
not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Dated: December 15, 2023
/s/ David J. Katzoff |
|
Name: David J. Katzoff |
|
Title: Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
|
EXHIBIT 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT
TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly
report of Alzamend Neuro, Inc. (the “Company”) on Form 10-Q for the period ended October 31, 2023, as filed with
the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned certify, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) the Report fully complies
with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained
in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
Date: December 15, 2023 |
|
|
|
|
By: /s/ Stephan Jackman |
|
Name: Stephan Jackman |
|
Title: Chief Executive Officer |
|
(Principal Executive Officer) |
Date: December 15, 2023 |
|
|
|
|
By: /s/ David J. Katzoff |
|
Name: David J. Katzoff |
|
Title: Chief Financial Officer |
|
(Principal Financial and Accounting Officer) |
v3.23.3
Cover - shares
|
6 Months Ended |
|
Oct. 31, 2023 |
Dec. 14, 2023 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Oct. 31, 2023
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--04-30
|
|
Entity File Number |
001-40483
|
|
Entity Registrant Name |
ALZAMEND NEURO, INC.
|
|
Entity Central Index Key |
0001677077
|
|
Entity Tax Identification Number |
81-1822909
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
3480 Peachtree Road NE
|
|
Entity Address, Address Line Two |
Second Floor
|
|
Entity Address, Address Line Three |
Suite 103
|
|
Entity Address, City or Town |
Atlanta
|
|
Entity Address, State or Province |
GA
|
|
Entity Address, Postal Zip Code |
30326
|
|
City Area Code |
(844)
|
|
Local Phone Number |
722-6303
|
|
Title of 12(b) Security |
Common Stock, $0.0001 par value per share
|
|
Trading Symbol |
ALZN
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
true
|
|
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|
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v3.23.3
Condensed Balance Sheets (Unaudited) - USD ($)
|
Oct. 31, 2023 |
Apr. 30, 2023 |
CURRENT ASSETS |
|
|
Cash |
$ 200,079
|
$ 5,140,859
|
Prepaid expenses and other current assets |
581,802
|
447,589
|
Prepaid expenses - related party |
|
247,334
|
TOTAL CURRENT ASSETS |
781,881
|
5,835,782
|
Property, plant and equipment, net |
201,716
|
79,843
|
TOTAL ASSETS |
983,597
|
5,915,625
|
CURRENT LIABILITIES |
|
|
Accounts payable and accrued liabilities |
3,666,090
|
2,870,122
|
TOTAL LIABILITIES, ALL CURRENT |
3,666,090
|
2,870,122
|
STOCKHOLDERS’ (DEFICIT) EQUITY |
|
|
Convertible Preferred stock, $0.0001 par value: 10,000,000 shares authorized; Series A Convertible Preferred Stock, $0.0001 stated value per share, 1,360,000 shares designated; nil 0 issued and outstanding as of October 31, 2023 and April 30, 2023 |
|
|
Common stock, $0.0001 par value: 300,000,000 shares authorized; 6,469,657 and 6,462,675 issued and outstanding as of October 31, 2023 and April 30, 2023, respectively |
647
|
646
|
Additional paid-in capital |
62,699,614
|
62,000,814
|
Note receivable for common stock – related party |
(14,876,293)
|
(14,883,295)
|
Accumulated deficit |
(50,506,461)
|
(44,072,662)
|
TOTAL STOCKHOLDERS’ (DEFICIT) EQUITY |
(2,682,493)
|
3,045,503
|
TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY |
$ 983,597
|
$ 5,915,625
|
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v3.23.3
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Oct. 31, 2023 |
Apr. 30, 2023 |
Preferred stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
10,000,000
|
10,000,000
|
Common stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
300,000,000
|
300,000,000
|
Common stock, shares issued |
6,469,657
|
6,462,675
|
Common stock, shares outstanding |
6,469,657
|
6,462,675
|
Series A Preferred Stock [Member] |
|
|
Preferred stock, par value (in dollars per share) |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
8,640,000
|
|
Preferred stock shares designated |
1,360,000
|
1,360,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
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v3.23.3
Condensed Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Oct. 31, 2023 |
Oct. 31, 2022 |
OPERATING EXPENSES |
|
|
|
|
Research and development |
$ 1,996,783
|
$ 1,532,985
|
$ 4,362,920
|
$ 2,908,940
|
General and administrative |
904,939
|
1,573,418
|
2,064,732
|
3,233,005
|
Total operating expenses |
2,901,722
|
3,106,403
|
6,427,652
|
6,141,945
|
Loss from operations |
(2,901,722)
|
(3,106,403)
|
(6,427,652)
|
(6,141,945)
|
OTHER EXPENSE, NET |
|
|
|
|
Interest expense |
(4,311)
|
(3,588)
|
(6,147)
|
(5,120)
|
Total other expense, net |
(4,311)
|
(3,588)
|
(6,147)
|
(5,120)
|
NET LOSS |
$ (2,906,033)
|
$ (3,109,991)
|
$ (6,433,799)
|
$ (6,147,065)
|
Basic net loss per common share |
$ (0.44)
|
$ (0.48)
|
$ (0.98)
|
$ (0.95)
|
Diluted net loss per common share |
$ (0.44)
|
$ (0.48)
|
$ (0.98)
|
$ (0.95)
|
Basic weighted average common shares outstanding |
6,563,784
|
6,499,230
|
6,563,230
|
6,499,008
|
Diluted weighted average common shares outstanding |
6,563,784
|
6,499,230
|
6,563,230
|
6,499,008
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.23.3
Condensed Statements of Stockholders' (Deficit) Equity (Unaudited) - USD ($)
|
Series A Convertible Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Note Recievable For Common Stock Related Party [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Apr. 30, 2022 |
|
$ 637
|
$ 57,428,664
|
$ (14,883,295)
|
$ (29,194,495)
|
$ 13,351,511
|
Beginning balance (in shares) at Apr. 30, 2022 |
|
6,365,453
|
|
|
|
|
Issuance of common stock for restricted stock awards |
|
$ 1
|
(1)
|
|
|
|
Issuance of common stock for restricted stock awards, shares |
|
833
|
|
|
|
|
Stock-based compensation to employees and consultants |
|
|
1,582,977
|
|
|
1,582,977
|
Net loss |
|
|
|
|
(6,147,065)
|
(6,147,065)
|
Ending balance, value at Oct. 31, 2022 |
|
$ 638
|
59,011,640
|
(14,883,295)
|
(35,341,560)
|
8,787,423
|
Ending balance (in shares) at Oct. 31, 2022 |
|
6,366,286
|
|
|
|
|
Beginning balance, value at Jul. 31, 2022 |
|
$ 637
|
58,296,002
|
(14,883,295)
|
(32,231,569)
|
11,181,775
|
Beginning balance (in shares) at Jul. 31, 2022 |
|
6,365,453
|
|
|
|
|
Issuance of common stock for restricted stock awards |
|
$ 1
|
(1)
|
|
|
|
Issuance of common stock for restricted stock awards, shares |
|
833
|
|
|
|
|
Stock-based compensation to employees and consultants |
|
|
715,639
|
|
|
715,639
|
Net loss |
|
|
|
|
(3,109,991)
|
(3,109,991)
|
Ending balance, value at Oct. 31, 2022 |
|
$ 638
|
59,011,640
|
(14,883,295)
|
(35,341,560)
|
8,787,423
|
Ending balance (in shares) at Oct. 31, 2022 |
|
6,366,286
|
|
|
|
|
Beginning balance, value at Apr. 30, 2023 |
|
$ 646
|
62,000,814
|
(14,883,295)
|
(44,072,662)
|
3,045,503
|
Beginning balance (in shares) at Apr. 30, 2023 |
|
6,462,675
|
|
|
|
|
Issuance of common stock for cash, net of issuance costs |
|
$ 1
|
18,086
|
|
|
18,087
|
Issuance of common stock for cash, net of issuance costs, shares |
|
6,149
|
|
|
|
|
Issuance of common stock for restricted stock awards |
|
|
|
|
|
|
Issuance of common stock for restricted stock awards, shares |
|
833
|
|
|
|
|
Subscription receivable payment received |
|
|
(7,002)
|
7,002
|
|
|
Stock-based compensation to employees and consultants |
|
|
687,716
|
|
|
687,716
|
Net loss |
|
|
|
|
(6,433,799)
|
(6,433,799)
|
Ending balance, value at Oct. 31, 2023 |
|
$ 647
|
62,699,614
|
(14,876,293)
|
(50,506,461)
|
(2,682,493)
|
Ending balance (in shares) at Oct. 31, 2023 |
|
6,469,657
|
|
|
|
|
Beginning balance, value at Jul. 31, 2023 |
|
$ 646
|
62,370,194
|
(14,883,295)
|
(47,600,428)
|
(112,883)
|
Beginning balance (in shares) at Jul. 31, 2023 |
|
6,462,675
|
|
|
|
|
Issuance of common stock for cash, net of issuance costs |
|
$ 1
|
18,086
|
|
|
18,087
|
Issuance of common stock for cash, net of issuance costs, shares |
|
6,149
|
|
|
|
|
Issuance of common stock for restricted stock awards |
|
|
|
|
|
|
Issuance of common stock for restricted stock awards, shares |
|
833
|
|
|
|
|
Subscription receivable payment received |
|
|
(7,002)
|
7,002
|
|
|
Stock-based compensation to employees and consultants |
|
|
318,336
|
|
|
318,336
|
Net loss |
|
|
|
|
(2,906,033)
|
(2,906,033)
|
Ending balance, value at Oct. 31, 2023 |
|
$ 647
|
$ 62,699,614
|
$ (14,876,293)
|
$ (50,506,461)
|
$ (2,682,493)
|
Ending balance (in shares) at Oct. 31, 2023 |
|
6,469,657
|
|
|
|
|
X |
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v3.23.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Cash flows from operating activities: |
|
|
Net loss |
$ (6,433,799)
|
$ (6,147,065)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation expense |
25,370
|
12,420
|
Stock-based compensation to employees and consultants |
687,716
|
1,582,977
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other current assets |
(134,213)
|
(59,851)
|
Prepaid expenses - related party |
247,334
|
245,251
|
Accounts payable and accrued liabilities |
795,968
|
(514,731)
|
Net cash used in operating activities |
(4,811,624)
|
(4,880,999)
|
Cash flows from investing activities: |
|
|
Purchase of equipment |
(147,243)
|
|
Net cash used in investing activities |
(147,243)
|
|
Cash flows from financing activities: |
|
|
Proceeds from the issuance of common stock, net |
18,087
|
|
Net cash provided by financing activities |
18,087
|
|
Net decrease in cash |
(4,940,780)
|
(4,880,999)
|
Cash at beginning of period |
5,140,859
|
14,063,811
|
Cash at end of period |
$ 200,079
|
$ 9,182,812
|
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v3.23.3
DESCRIPTION OF BUSINESS
|
6 Months Ended |
Oct. 31, 2023 |
Accounting Policies [Abstract] |
|
DESCRIPTION OF BUSINESS |
| 1. | DESCRIPTION OF BUSINESS |
Organization
Alzamend Neuro, Inc. (the
“Company” or “Alzamend”), is a clinical-stage biopharmaceutical company focused on developing novel products for
the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder
(“MDD”) and post-traumatic stress disorder (“PTSD”). With two current product candidates, Alzamend aims to bring
treatments or cures to market at a reasonable cost as quickly as possible. The Company’s current pipeline consists of two novel
therapeutic drug candidates: (i) a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate,
known as AL001, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and (ii) a patented method using a mutant peptide sensitized cell as a cell-based therapeutic
vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s, known as ALZN002, through
a royalty-bearing exclusive worldwide license from the same Licensor.
The Company is devoting substantially
all its efforts towards research and development of its two product candidates and raising capital. The Company has not generated any
product revenue to date. The Company has financed its operations to date primarily through debt financings and through the sale of its
common stock, par value $0.0001 per share (“Common Stock”). The Company expects to continue to incur net losses in the foreseeable
future.
Reverse Stock Split
On October 27, 2023, pursuant to the authorization provided by the
Company’s stockholders at a special meeting of stockholders, the Company filed an amendment to the Certificate of Incorporation
to effectuate a reverse stock split of the Company’s issued and outstanding Common Stock by a ratio of one-for-fifteen (the “Reverse
Split”). The Reverse Split did not affect the number of authorized shares of Common Stock, preferred stock or their respective par
value per share. As a result of the Reverse Split, each fifteen shares of Common Stock issued and outstanding prior to the Reverse Split
were converted into one share of common stock. The Reverse Split became effective in the State of Delaware on October 31, 2023. All share
amounts in these condensed financial statements have been updated for all periods presented to reflect the Reverse Split.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.23.3
LIQUIDITY AND GOING CONCERN
|
6 Months Ended |
Oct. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
LIQUIDITY AND GOING CONCERN |
| 2. | LIQUIDITY AND GOING CONCERN |
The accompanying condensed financial statements have been prepared
on the basis that the Company will continue as a going concern. As of October 31, 2023, the Company had cash of $200,000, an accumulated
deficit of $50.5 million and stockholders’ deficit of $2.7 million. For the three and six months ended October 31, 2023, the Company
had net losses of $2.9 million and $6.4 million, respectively. For the six months ended October 31, 2023, cash used in operating activities
was $4.8 million. Historically, the Company has financed its operations principally through issuances of equity and debt instruments.
The Company believes its current
cash on hand is not sufficient to fund its planned operations through one year after the date the condensed financial statements are issued.
These factors create substantial doubt about the Company’s ability to continue as a going concern for at least one year after the
date that these condensed financial statements are issued.
The Company’s inability to continue as a going concern could have
a negative impact on the company, including our ability to obtain needed financing. The Company’s condensed
financial statements do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts
and classifications of liabilities that might be necessary should it be unable to continue as a going concern.
In order to continue as a
going concern, the Company will need to raise additional funds. The Company has raised funds subsequent to the quarter end through an
“at-the-market” offering, and plans to seek additional funding through public equity, including the “at-the-market”
offering, private equity and debt financings. Additional funds may also be received from the exercise of warrants (Note 7) and the receipt
of funds from the note receivable (Note 4). The terms of any additional financing may adversely affect the holdings or rights of the Company’s
stockholders. If the Company is unable to obtain funding, it could be required to delay, reduce or eliminate research and development
programs and planned clinical trials which could adversely affect the Company’s business operations.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Oct. 31, 2023 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
| 3. | SIGNIFICANT ACCOUNTING POLICIES |
Basis of Presentation
The accompanying condensed financial statements of the Company have
been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and
the rules of the Securities and Exchange Commission (“SEC”) applicable to interim reports of companies filing as a smaller
reporting company. These condensed financial statements should be read in conjunction with the audited financial statements and notes
thereto contained in the Company’s Report on Form 10-K for the year ended April 30, 2023, filed with the SEC on July 27, 2023. In
the opinion of management, the accompanying condensed interim financial statements include all adjustments necessary in order to make
the condensed financial statements not misleading. The results of operations for interim periods are not necessarily indicative of the
results to be expected for the full year or any other future period. Certain notes to the condensed financial statements that would substantially
duplicate the disclosures contained in the audited financial statements for the most recent fiscal year as reported in the Company’s
Report on Form 10-K have been omitted. The accompanying condensed balance sheet at April 30, 2023 has been derived from the audited balance
sheet at April 30, 2023 contained in such Form 10-K.
Accounting Estimates
The preparation of condensed financial statements, in conformity with
U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the
reporting period. The Company’s significant accounting policies that involve significant judgment and estimates include stock-based
compensation, warrant valuation, and valuation of deferred income taxes. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all
highly liquid investments with a remaining maturity of three months or less when purchased to be cash equivalents. As of October 31, 2023
and April 30, 2023, the Company had no cash equivalents.
Fair Value of Financial
Instruments
Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, defines fair value
as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques
used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy
is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last
is considered unobservable:
Level 1: Quoted prices in
active markets for identical assets or liabilities.
Level 2: Inputs other than
Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the
full term of the assets or liabilities.
Level 3 assumptions: Unobservable
inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including
liabilities resulting from imbedded derivatives associated with certain warrants to purchase Common Stock.
The fair values of warrants
are determined using the Black-Scholes valuation model, a “Level 3” fair value measurement, based on the estimated fair value
of Common Stock, volatility based on the historical volatility data of similar companies, considering the industry, products and market
capitalization of such other entities, the expected life based on the remaining contractual term of the warrants and the risk free interest
rate based on the implied yield available on U.S. Treasury Securities with a maturity equivalent to the warrants’ contractual life.
Property and Equipment,
Net
Property and equipment are
stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life
of five years. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred.
Research and Development
Expenses
Research and development costs
are expensed as incurred. Research and development costs consist of scientific consulting fees, clinical trial fees and lab supplies,
as well as fees paid to other entities that conduct certain research and development activities on behalf of the Company.
The Company has acquired and
may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire
license, products or rights, as well as any future milestone payments, are immediately recognized as research and development expense
provided that there is no alternative future use of the rights in other research and development projects.
Stock-Based Compensation
The Company recognizes stock-based
compensation expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they
occur. The Company’s stock-based compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes
option pricing model. To the extent any stock option grants are made subject to the achievement of a performance-based milestone, management
evaluates when the achievement of any such performance-based milestone is probable based on the relative satisfaction of the performance
conditions as of the reporting date.
The Company recognizes stock-based
compensation expense for restricted stock units on a straight-line basis over the requisite service period and account for forfeitures
as they occur. The Company’s stock-based compensation for restricted stocks is based upon the estimated fair value of the Common
Stock.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. Certain of such assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and the
Company uses significantly different assumptions or estimates, the Company’s stock-based compensation could be materially different.
Warrants
The Company accounts for stock
warrants as either equity instruments, derivative liabilities, or liabilities in accordance with FASB ASC 480, Distinguishing
Liabilities from Equity and FASB ASC 815, Derivatives and Hedging, depending on the specific terms of the warrant
agreement.
Loss
per Common Share
The Company utilizes FASB
ASC 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common stockholders by the weighted-average
number of common shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is
increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued
and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible
preferred stock, options and warrants were to be exercised or converted or otherwise resulted in the issuance of Common Stock that then
shared in the earnings of the entity.
Since the effects of outstanding
stock options, restricted stock units and warrants are anti-dilutive in the periods presented, shares of Common Stock underlying these
instruments have been excluded from the computation of loss per common share.
The following sets forth the
number of shares of Common Stock underlying outstanding stock options, restricted stock units and warrants that have been excluded from
the computation of loss per common share:
Schedule of antidilutive securities excluded from computation of earnings per share | |
| | | |
| | |
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | |
Stock options (1) | |
| 1,210,554 | | |
| 1,687,209 | |
Restricted stock units | |
| 2,500 | | |
| 4,167 | |
Warrants | |
| 676,649 | | |
| 676,649 | |
| |
| 1,889,703 | | |
| 2,368,025 | |
| (1) | The Company has excluded 100,000 and 333,333 stock options for the six months ended October 31, 2023 and
2022, respectively, with an exercise price of $0.006, from its anti-dilutive securities as these shares have been included in our determination
of basic loss per share as they represent shares issuable for little or no cash consideration upon the satisfaction of certain conditions
pursuant to FASB ASC 260-10-45-14. |
Recent Accounting Standards
From time to time, new accounting
pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact
of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s financial position
or results of operations upon adoption.
The Company has considered all other recently issued accounting standards
and does not believe the adoption of such standards will have a material impact on its condensed financial statements.
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v3.23.3
NOTE RECEIVABLE FOR COMMON STOCK, RELATED PARTY
|
6 Months Ended |
Oct. 31, 2023 |
Note Receivable For Common Stock Related Party |
|
NOTE RECEIVABLE FOR COMMON STOCK, RELATED PARTY |
| 4. | NOTE RECEIVABLE FOR COMMON STOCK, RELATED PARTY |
On April 30, 2019, the Company
and Ault Life Sciences Fund, LLC (“ALSF”) entered into a securities purchase agreement for the purchase of 666,666 shares
of Common Stock for a total purchase price of $15,000,000, or $22.50 per share with 333,333 warrants with a 5-year life and an exercise
price of $45.00 per share and vesting upon issuance. The total purchase price of $15,000,000 was in the form of a non-interest bearing
note receivable with a 12-month term from ALSF, a related party. In November 2019, the term of the note receivable was extended to December
31, 2021, and in May 2021, the term of the note receivable was extended to December 31, 2023. The note is secured by a pledge of the purchased
shares. As the note receivable from ALSF is related to the issuance of Common Stock, it is recorded as an offset to additional paid-in
capital. At October 31, 2023 and April 30, 2023, the outstanding balance of the note receivable was $14,876,293 and $14,883,295, respectively.
ALSF is wholly owned by Ault Life Sciences, Inc. (“ALSI”). ALSI is majority owned by Ault & Company, Inc. (“Ault
& Co.”). Messrs. Horne and Nisser, directors of the Company, are also directors of Ault & Co.
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v3.23.3
PREPAID EXPENSES AND OTHER CURRENT ASSETS
|
6 Months Ended |
Oct. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
PREPAID EXPENSES AND OTHER CURRENT ASSETS |
5. PREPAID
EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other
current assets were as follows:
Schedule of prepaid expenses and other current assets | |
| | | |
| | |
| |
October 31, 2023 | | |
April 30, 2023 | |
Prepaid clinical trial fees | |
$ | 326,211 | | |
$ | 352,635 | |
Prepaid insurance | |
| 235,576 | | |
| 92,154 | |
Other prepaid expenses | |
| 20,015 | | |
| 2,800 | |
Total prepaid expenses and other current assets | |
$ | 581,802 | | |
$ | 447,589 | |
Prepaid clinical trial fees
at October 31, 2023 and April 30, 2023 represented the unused portion of the prepaid clinical trial fees. On June 14, 2023, the Company purchased directors’ and officers’
insurance for 12 months in the amount of $337,000. Prepaid insurance at October
31, 2023 represented the unamortized portion of directors’ and officers’ insurance.
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v3.23.3
STOCK-BASED COMPENSATION
|
6 Months Ended |
Oct. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
| 6. | STOCK-BASED COMPENSATION |
2016 Stock Incentive
Plan
On April 30, 2016, the Company’s
stockholders approved the Company’s 2016 Stock Incentive Plan (the “Plan”). The Plan provides for the issuance of a
maximum of 833,333 shares of Common Stock to be offered to the Company’s directors, officers, employees, and consultants. On March
1, 2019, the Company’s stockholders approved an additional 500,000 shares to be available for issuance under the Plan. Options granted
under the Plan have an exercise price equal to or greater than the fair value of the underlying Common Stock at the date of grant and
become exercisable based on a vesting schedule determined at the date of grant. The options expire between five and 10 years from the
date of grant. Restricted stock awards granted under the Plan are subject to a vesting period determined at the date of grant.
2021 Stock Incentive
Plan
In February 2021, the Company’s
board of directors (the “Board”) adopted, and the stockholders approved, the Alzamend Neuro, Inc. 2021 Stock Incentive Plan
(the “2021 Plan”). The 2021 Plan authorizes the grant to eligible individuals of (1) stock options (incentive and non-statutory),
(2) restricted stock, (3) stock appreciation rights, or SARs, (4) restricted stock units, and (5) other stock-based compensation.
Stock Subject to the 2021
Plan. The maximum number of shares of Common Stock that may be issued under the 2021 Plan is 666,667 shares, which number will
be increased to the extent that compensation granted under the 2021 Plan is forfeited, expires or is settled for cash (except as otherwise
provided in the 2021 Plan). Substitute awards (awards made or shares issued by the Company in assumption of, or in substitution or exchange
for, awards previously granted, or the right or obligation to make future awards, in each case by a company that the Company acquires
or any subsidiary of the Company or with which the Company or any subsidiary combines) will not reduce the shares authorized for grant
under the 2021 Plan, nor will shares subject to a substitute award be added to the shares available for issuance or transfer under the
2021 Plan.
All options that the Company
grants are granted at the per share fair value on the grant date. Vesting of options differs based on the terms of each option. The Company
has valued the options at their date of grant utilizing the Black-Scholes option pricing model. As of the date of issuance of these options,
there was not an active public market for the Company’s shares. Accordingly, the fair value of the underlying options was determined
based on the historical volatility data of similar companies, considering the industry, products and market capitalization of such other
entities. The risk-free interest rate used in the calculations is based on the implied yield available on U.S. Treasury issues with an
equivalent term approximating the expected life of the options as calculated using the simplified method. The expected life of the options
used was based on the contractual life of the option granted. Stock-based compensation is a non-cash expense because the Company settles
these obligations by issuing shares of Common Stock from its authorized shares instead of settling such obligations with cash payments.
A summary of stock option
activity for the six months ended October 31, 2023 is presented below:
Schedule of share-based payment arrangement, option, activity | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
Outstanding Options | |
| |
Shares Available for Grant | | |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (years) | | |
Aggregate Intrinsic Value | |
Balance at April 30, 2023 | |
| 612,778 | | |
| 987,222 | | |
$ | 18.96 | | |
| 6.18 | | |
$ | 819,900 | |
Options granted | |
| - | | |
| - | | |
$ | - | | |
| - | | |
| | |
Options exercised | |
| - | | |
| - | | |
$ | - | | |
| - | | |
| | |
Options expired | |
| 7,222 | | |
| (7,222 | ) | |
$ | 75.00 | | |
| - | | |
| | |
Balance at October 31, 2023 | |
| 620,000 | | |
| 980,000 | | |
$ | 18.96 | | |
| 5.72 | | |
$ | 174,500 | |
Options vested and expected to vest at October 31, 2023 | | |
| 913,334 | | |
$ | 17.83 | | |
| 5.47 | | |
$ | 174,500 | |
Options exercisable at October 31, 2023 | |
| | | |
| 895,679 | | |
$ | 17.39 | | |
| 4.37 | | |
$ | 174,500 | |
The aggregate intrinsic value
in the table above represents the total pretax intrinsic value (i.e., the difference between the estimated fair value on the respective
date and the exercise price, times the number of shares) that would have been received by the option holders had all option holders exercised
their options.
Restricted stock unit activity
for the six months ended October 31, 2023 is presented below:
| | |
| | | |
| | |
| | |
Shares | | |
Weighted Average
Grant Date Fair Value | |
Unvested at April 30, 2023 | | |
| 3,333 | | |
$ | 2.50 | |
Granted | | |
| - | | |
| - | |
Vested | | |
| (833 | ) | |
| 2.50 | |
Cancelled | | |
| - | | |
| - | |
Unvested at October 31, 2023 | | |
| 2,500 | | |
$ | 2.50 | |
Performance Contingent
Stock Options Granted to Employee
On November 26, 2019, the
Board granted 283,333 performance- and market-contingent awards to certain key employees and a director. These grants were made outside
of the Plan. These awards have an exercise price of $22.50 per share. These awards have multiple separate market triggers for vesting
based upon either (i) the successful achievement of tiered target closing prices on a national securities exchange for 90 consecutive
trading days later than 180 days after the Company’s initial public offering (“IPO”) for its Common Stock, or (ii) tiered
target prices for a change in control transaction. The target prices ranged from $150 per share to $600 per share. In the event any of
the stock price milestones are not achieved within three years, the unvested portion of the performance options will be reduced by 25%.
On November 22, 2022, the
Compensation Committee of the Board modified the performance criteria for these awards. The target price range is now $150 per share to
$300 per share. Additionally, if the stock price milestones are now not achieved by November 27, 2026, as opposed to within three years,
the unvested portion of the performance options will be reduced by 25%. Due to the significant risks and uncertainties associated with
achieving the market-contingent awards, as of October 31, 2023, the Company believed that the achievement of the requisite performance
conditions was not probable and, as a result, no compensation cost has been recognized for these awards.
On November 29, 2022, the
Compensation Committee of the Board granted 133,333 performance-based stock option to the Chief Executive Officer at an exercise price
of $17.55 per share, of which 50% vest upon the completion and announcement of topline data from the Company’s Phase II clinical
trial of AL001 within three years from grant date and the remaining 50% vest upon the completion and announcement of topline data from
the Company’s Phase I/IIA clinical trial of ALZN002 within four years from the grant date. During the three months ended January
31, 2023, the Company believed that it was probable that the performance condition of the completion and announcement of topline data
from the Company’s Phase II clinical trial of AL001 would be achieved and had recognized the related stock-based compensation. As
of October 31, 2023, the Company believed that the achievement of the second performance condition was not probable and, as a result,
no compensation cost has been recognized related to Phase I/IIA of ALZN002.
Performance Contingent
Stock Options Granted to TAMM Net
On March 23, 2021, the Company
issued performance-based stock options to certain team members at TAMM Net, Inc. (“TAMM Net”) to purchase an aggregate of
30,000 shares of Common Stock at a per share exercise price of $22.50 per share, of which 50% would vest upon the completion of Phase
I of AL001 by March 31, 2022, and the remaining 50% would vest upon completion of Phase I/IIA of ALZN002 by December 31, 2022.
The performance goal of completing Phase I of AL001 was achieved on
March 22, 2022, and the Company recognized stock-based compensation related to the completion of Phase I of AL001 over the implied service
period to complete this milestone.
On January 19, 2023, the Board
modified the performance criteria for these awards. The remaining 50% of the grant will now vest upon the completion and announcement
of topline data of the first cohort from a Phase I/IIA clinical trial of ALZN002 on/or before March 31, 2024. Due to the significant risks
and uncertainties associated with achieving the completion of Phase I/IIA for ALZN002, as of October 31, 2023, the Company believed that
the achievement of the requisite performance conditions was not probable and, as a result, no compensation cost has been recognized for
these awards related to ALZN002.
Performance Contingent
Stock Options Granted to Consultants
On October 14, 2021, the Company
issued performance-based stock options to two consultants to purchase an aggregate of 13,333 shares of Common Stock with an exercise price
of $36.30 per share, of which 3,333 vest upon completion of each of the Phase II clinical trials of AL001 for a BD indication, AL001 for
a PTSD indication, AL001 for an MDD indication and ALZN002 for an Alzheimer’s indication.
On January 19, 2023, the Board
modified the performance criteria for these awards. The revised grant will vest 25% if the Company (a) completes and announces topline
data from a Phase II clinical trial of AL001 and ALZN002, as applicable, that would support a new drug application for the drug candidate
and the indication listed below, and (b) obtained a “Study May Proceed” letter from the U.S. Food and Drug Administration
(“FDA”) for the additional Investigational New Drug (“IND”) on/or before December 31, 2023, as follows: (i) AL001
– bipolar disorder; (ii) AL001- major depressive disorder; (iii) AL001 – post-traumatic stress disorder; and (iv) ALZN002
– Alzheimer’s disease.
During the three months ended
October 31, 2023, the Company filed INDs for BD and MDD and received “Study May Proceed” letter for BD in October 2023 and
MDD in November 2023. As a result, 50% of the performance grant vested and the Company recognized stock-based compensation related to
the vesting and the probability of achieving the MDD criteria. As of October 31, 2023, the Company believed that the achievement of the
remaining requisite performance conditions was not probable and, as a result, no compensation cost has been recognized for these awards
related to Phase II of AL001 – post-traumatic stress disorder and ALZN002 – Alzheimer’s disease.
Stock-Based Compensation
Expense
The Company’s results
of operations included expenses relating to stock-based compensation for three and six months ended October 31, 2023 and 2022 comprised
as follows:
Schedule of stock-based compensation | |
| | |
| | |
| | |
| |
| |
For the Three Months Ended October 31, | | |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 142,603 | | |
$ | - | | |
$ | 142,603 | | |
$ | - | |
General and administrative | |
| 175,733 | | |
| 715,639 | | |
| 545,113 | | |
| 1,582,977 | |
Total stock-based compensation | |
$ | 318,336 | | |
$ | 715,639 | | |
$ | 687,716 | | |
$ | 1,582,977 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
WARRANTS
|
6 Months Ended |
Oct. 31, 2023 |
Warrants |
|
WARRANTS |
As of October 31, 2023, total
unamortized stock-based compensation expense related to unvested employee and non-employee awards that are expected to vest was $518,000.
The weighted-average period over which such stock-based compensation expense will be recognized was approximately 1.7 years.
The following table summarizes
information about Common Stock warrants outstanding and exercisable at October 31, 2023:
Schedule of common stock warrants outstanding | |
| | | |
| | | |
| | |
| | | |
| | |
Outstanding | |
Exercisable | |
| |
| | |
Weighted | | |
| |
| | |
| |
| |
| | |
Average | | |
Weighted | |
| | |
Weighted | |
| |
| | |
Remaining | | |
Average | |
| | |
Average | |
Exercise | |
Number | | |
Contractual | | |
Exercise | |
Number | | |
Exercise | |
Price | |
Outstanding | | |
Life (years) | | |
Price | |
Exercisable | | |
Price | |
$15.00 | |
| 33,333 | | |
| 0.3 | | |
$ | 15.00 | |
| 33,333 | | |
$ | 15.00 | |
$26.25 | |
| 10,756 | | |
| 1.0 | | |
$ | 26.25 | |
| 10,756 | | |
$ | 26.25 | |
$45.00 | |
| 628,477 | | |
| 1.4 | | |
$ | 45.00 | |
| 628,477 | | |
$ | 45.00 | |
$93.75 | |
| 4,083 | | |
| 2.6 | | |
$ | 93.75 | |
| 4,083 | | |
$ | 93.75 | |
| |
| | | |
| | | |
| | |
| | | |
| | |
$15.00 - $93.75 | |
| 676,649 | | |
| 1.4 | | |
$ | 43.52 | |
| 676,649 | | |
$ | 43.52 | |
|
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v3.23.3
COMMITMENTS AND CONTINGENCIES
|
6 Months Ended |
Oct. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
| 8. | COMMITMENTS AND CONTINGENCIES |
Contractual Obligations
On
July 2, 2018, the Company entered into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and
its affiliate, the University of South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted the Company
a royalty bearing exclusive worldwide licenses limited to the field of Alzheimer’s, under United States Patent Nos. (i) 9,840,521,
entitled “Organic Anion Lithium Ionic Cocrystal Compounds and Compositions”, filed September 24, 2015 and granted December
12, 2017, and (ii) 9,603,869, entitled “Lithium Co-Crystals for Treatment of Neuropsychiatric Disorders”, filed May 21, 2016
and granted March 28, 2017. On February 1, 2019, the Company entered into the First Amendments to the AL001 Licenses, on March 30, 2021,
the Company entered into the Second Amendments to the AL001 Licenses and on June 8, 2023, the Company entered into the Third Amendments
to the AL001 Licenses (collectively, the “AL001 License Agreements”). The Third Amendments to the AL001 Licenses modified
the timing of the payments for the license fees.
The
AL001 License Agreements require that the Company pay combined royalty payments of 4.5% on net sales of products developed from
the licensed technology for AL001. The Company has already paid an initial license fee of $200,000 for AL001. As an additional
licensing fee for the license of the AL001 technologies, the Licensor received 148,528 shares of Common Stock. Minimum royalties
for AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary
of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every year thereafter, for the
life of the AL001 License Agreements.
On May 1, 2016, the Company entered into a Standard Exclusive License
Agreement with Sublicensing Terms for ALZN002 with the Licensor (the “ALZN002 License”), pursuant to which the Licensor granted
the Company a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy and Diagnostics, under
United States Patent No. 8,188,046, entitled “Amyloid Beta Peptides and Methods of Use”, filed April 7, 2009 and granted May
29, 2012. On August 18, 2017, the Company entered into the First Amendment to the ALZN002 License, on May 7, 2018, the Company entered
into the Second Amendment to the ALZN002 License, on January 31, 2019, the Company entered into the Third Amendment to the ALZN002 License,
on January 24, 2020, the Company entered into the Fourth Amendment to the ALZN002 License, on March 30, 2021, the Company entered into
the Fifth Amendment to the ALZN002 License, on April 17, 2023, the Company entered into the Sixth Amendment to the ALZN002 License and
on December 11, 2023, the Company entered into the Seventh Amendment to the ALZN002 License (collectively, the “ALZN002 License
Agreement”). The Seventh Amendment to the ALZN002 License modified the timing of the payments for the license fees.
The
ALZN002 License Agreement requires the Company to pay royalty payments of 4% on net sales of products developed from the licensed
technology for ALZN002. The Company has already paid an initial license fee of $200,000 for ALZN002. As an additional licensing
fee for the license of ALZN002, the Licensor received 240,120 shares of Common Stock. Minimum royalties for ALZN002 are $20,000 on
the first anniversary of the first commercial sale, $40,000 on the second anniversary of the first commercial sale and $50,000 on
the third anniversary of the first commercial sale and every year thereafter, for the life of the ALZN002 License Agreement.
On
November 19, 2019, the Company entered into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications
of AL001 with the Licensor (the “November AL001 License”), pursuant to which the Licensor granted the Company a royalty bearing
exclusive worldwide licenses limited to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric
diseases and disorders. On March 30, 2021, the Company entered into the First Amendments to the November AL001 License and on April 17,
2023, the Company entered into the Second Amendments to the November AL001 License (collectively, the “November AL001 License Agreements”).
The Second Amendments to the November AL001 License modified the timing of the payments for the license fees.
The
November AL001 License Agreements require the Company to pay royalty payments of 3% on net sales of products developed from
the licensed technology for AL001 in those fields. The Company paid an initial license fee of $20,000 for the additional indications.
Minimum royalties for November AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on
the second anniversary of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every
year thereafter, for the life of the November AL001 License Agreements.
These
license agreements have an indefinite term that continue until the later of the date no licensed patent under the applicable agreement
remains a pending application or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory
body, or the date on which the Company’s obligations to pay royalties expire under the applicable license agreement. Under the various
license agreements, if the Company fails to meet a milestone by its specified date, Licensor may terminate the license agreement. The
Licensor was also granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by
the Company while the Licensor remains the owner of any equity securities of the Company.
Additionally,
the Company is required to pay milestone payments on the due dates to the Licensor for the license of the AL001 technologies and for the
ALZN002 technology, as follows:
Original AL001 Licenses:
|
Schedule of contractual obligation, fiscal year maturity |
|
|
|
|
Payment |
|
Due Date |
|
Event |
$ |
50,000 |
* |
Completed September 2019 |
|
Pre-IND meeting |
|
|
|
|
|
|
$ |
65,000 |
* |
Completed June 2021 |
|
IND application filing |
|
|
|
|
|
|
$ |
190,000 |
* |
Completed December 2021 |
|
Upon first dosing of patient in a clinical trial |
|
|
|
|
|
|
$ |
500,000 |
* |
Completed March 2022 |
|
Upon completion of first clinical trial |
|
|
|
|
|
|
$ |
1,250,000 |
|
March 2025 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
10,000,000 |
|
8 years from the effective date of the agreement |
|
Upon FDA approval |
| * | Milestone met and completed |
ALZN002 License:
Payment |
|
Due Date |
$ |
50,000 |
* |
Completed January 2022 |
|
|
|
|
$ |
50,000 |
|
Upon first dosing of patient in first Phase I clinical trial |
|
|
|
|
$ |
500,000 |
|
Upon completion of first Phase IIb clinical trial |
|
|
|
|
$ |
1,000,000 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
$ |
10,000,000 |
|
Upon first commercial sale |
| * | Milestone met and completed |
Additional
AL001 Licenses:
Payment |
|
Due Date |
|
Event |
$ |
2,000,000 |
|
March 2026 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
16,000,000 |
|
August 1, 2029 |
|
First commercial sale |
|
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v3.23.3
EQUITY TRANSACTIONS
|
6 Months Ended |
Oct. 31, 2023 |
Equity [Abstract] |
|
EQUITY TRANSACTIONS |
The
Company is authorized to issue 10,000,000 shares of Preferred Stock $0.0001 par value. The Board has designated 1,360,000 shares as the
Series A Convertible Preferred Stock. The rights, preferences, privileges and restrictions on the remaining authorized 8,640,000 shares
of Preferred Stock have not been determined. The Board is authorized to create a new series of preferred shares and determine the number
of shares, as well as the rights, preferences, privileges and restrictions granted to or imposed upon any series of preferred shares.
Series A Convertible
Preferred Stock
As of October 31, 2023, there
were no shares of Series A Convertible Preferred Stock issued or outstanding.
Common Stock
ALSF Investment
On April 30, 2019, the Company
and ALSF entered into a securities purchase agreement (the “SPA”) for the purchase of 666,667 shares of Common Stock for a
total purchase price of $15,000,000, or $22.50 per share with 333,333 warrants with a 5-year life and an exercise price of $45.00 per
share and vesting upon issuance. The total purchase price of $15,000,000 was in the form of a non-interest bearing note receivable with
a 12-month term from ALSF, a related party. The note is secured by a pledge of the purchased shares. Pursuant to the SPA, ALSF is entitled
to full ratchet anti-dilution protection, most-favored nation status, denying the Company the right to enter into a variable rate transaction
absent its consent, a right to participate in any future financing the Company may consummate and to have all the shares of Common Stock
to which it is entitled under the SPA registered under the Securities Act within 180 days of the final closing of the IPO. In May 2021,
the term of the note receivable was extended to December 31, 2023. The note is secured by a pledge of the purchased shares.
At-the-Market Offering
On September 8, 2023, the
Company entered into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC, as sales agent to sell shares of
its Common stock, having an aggregate offering price of up to approximately $9.8 million (the “Shares”) from time to time,
through an “at the market offering” (the “ATM Offering”) as defined in Rule 415 under the Securities Act of 1933,
as amended (the “Securities Act”). On September 8, 2023, the Company filed a prospectus supplement with the SEC relating to
the offer and sale of up to approximately $9.8 million in shares of Common Stock in the ATM Offering.
The offer and sale of the
Shares will be made pursuant to the Company’s effective “shelf” registration statement on Form S-3 and an accompanying
base prospectus contained therein (Registration Statement No. 333-273610) filed with the SEC on August 2, 2023 and declared effective
by the SEC on August 10, 2023.
During the six months ended
October 31, 2023, the Company sold an aggregate of 6,149 shares of Common Stock pursuant to the ATM Offering for gross proceeds of $19,000.
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v3.23.3
OTHER RELATED PARTY TRANSACTIONS
|
6 Months Ended |
Oct. 31, 2023 |
Related Party Transactions [Abstract] |
|
OTHER RELATED PARTY TRANSACTIONS |
| 10. | OTHER RELATED PARTY TRANSACTIONS |
In November 2022, the Company
entered into a marketing and brand development agreement with Ault Alliance, Inc. (“AULT”), effective August 1, 2022, whereby
AULT will provide various marketing services over twelve months valued at $1.4 million. The Company had the right to pay the fee in cash
or shares of its common stock with a value of $22.50 per share. On November 11, 2022, the Company elected to pay the fee with 62,222 shares
of its common stock. The Company recorded the value of the agreement using the closing price of the Company’s common stock on November
11, 2022, and amortizes the expense over twelve months beginning in August 2022. At October 31, 2023, the balance of related party prepaid
expenses was zero.
|
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v3.23.3
SUBSEQUENT EVENTS
|
6 Months Ended |
Oct. 31, 2023 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
During
the period between November 1, 2023 through December 14, 2023, the Company sold an aggregate of 651,046 shares of Common Stock pursuant
to the ATM Offering for gross proceeds of $849,000.
On
December 11, 2023, the Company entered into the Seventh Amendment to the ALZN002 License. The Seventh Amendment to the ALZN002
License modified the timing of the payments for the license fees.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Oct. 31, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis of Presentation
The accompanying condensed financial statements of the Company have
been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and
the rules of the Securities and Exchange Commission (“SEC”) applicable to interim reports of companies filing as a smaller
reporting company. These condensed financial statements should be read in conjunction with the audited financial statements and notes
thereto contained in the Company’s Report on Form 10-K for the year ended April 30, 2023, filed with the SEC on July 27, 2023. In
the opinion of management, the accompanying condensed interim financial statements include all adjustments necessary in order to make
the condensed financial statements not misleading. The results of operations for interim periods are not necessarily indicative of the
results to be expected for the full year or any other future period. Certain notes to the condensed financial statements that would substantially
duplicate the disclosures contained in the audited financial statements for the most recent fiscal year as reported in the Company’s
Report on Form 10-K have been omitted. The accompanying condensed balance sheet at April 30, 2023 has been derived from the audited balance
sheet at April 30, 2023 contained in such Form 10-K.
|
Accounting Estimates |
Accounting Estimates
The preparation of condensed financial statements, in conformity with
U.S. GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the condensed financial statements and the reported amounts of expenses during the
reporting period. The Company’s significant accounting policies that involve significant judgment and estimates include stock-based
compensation, warrant valuation, and valuation of deferred income taxes. Actual results could differ from those estimates.
|
Cash and Cash Equivalents |
Cash and Cash Equivalents
The Company considers all
highly liquid investments with a remaining maturity of three months or less when purchased to be cash equivalents. As of October 31, 2023
and April 30, 2023, the Company had no cash equivalents.
|
Fair Value of Financial Instruments |
Fair Value of Financial
Instruments
Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification (“ASC”) 820, Fair Value Measurement, defines fair value
as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques
used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value hierarchy
is based on three levels of inputs that may be used to measure fair value, of which the first two are considered observable and the last
is considered unobservable:
Level 1: Quoted prices in
active markets for identical assets or liabilities.
Level 2: Inputs other than
Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the
full term of the assets or liabilities.
Level 3 assumptions: Unobservable
inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities including
liabilities resulting from imbedded derivatives associated with certain warrants to purchase Common Stock.
The fair values of warrants
are determined using the Black-Scholes valuation model, a “Level 3” fair value measurement, based on the estimated fair value
of Common Stock, volatility based on the historical volatility data of similar companies, considering the industry, products and market
capitalization of such other entities, the expected life based on the remaining contractual term of the warrants and the risk free interest
rate based on the implied yield available on U.S. Treasury Securities with a maturity equivalent to the warrants’ contractual life.
|
Property and Equipment, Net |
Property and Equipment,
Net
Property and equipment are
stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life
of five years. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred.
|
Research and Development Expenses |
Research and Development
Expenses
Research and development costs
are expensed as incurred. Research and development costs consist of scientific consulting fees, clinical trial fees and lab supplies,
as well as fees paid to other entities that conduct certain research and development activities on behalf of the Company.
The Company has acquired and
may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire
license, products or rights, as well as any future milestone payments, are immediately recognized as research and development expense
provided that there is no alternative future use of the rights in other research and development projects.
|
Stock-Based Compensation |
Stock-Based Compensation
The Company recognizes stock-based
compensation expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they
occur. The Company’s stock-based compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes
option pricing model. To the extent any stock option grants are made subject to the achievement of a performance-based milestone, management
evaluates when the achievement of any such performance-based milestone is probable based on the relative satisfaction of the performance
conditions as of the reporting date.
The Company recognizes stock-based
compensation expense for restricted stock units on a straight-line basis over the requisite service period and account for forfeitures
as they occur. The Company’s stock-based compensation for restricted stocks is based upon the estimated fair value of the Common
Stock.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. Certain of such assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and the
Company uses significantly different assumptions or estimates, the Company’s stock-based compensation could be materially different.
|
Warrants |
Warrants
The Company accounts for stock
warrants as either equity instruments, derivative liabilities, or liabilities in accordance with FASB ASC 480, Distinguishing
Liabilities from Equity and FASB ASC 815, Derivatives and Hedging, depending on the specific terms of the warrant
agreement.
|
Loss per Common Share |
Loss
per Common Share
The Company utilizes FASB
ASC 260, Earnings per Share. Basic loss per share is computed by dividing loss available to common stockholders by the weighted-average
number of common shares outstanding. Diluted loss per share is computed similar to basic loss per share except that the denominator is
increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued
and if the additional common shares were dilutive. Diluted loss per common share reflects the potential dilution that could occur if convertible
preferred stock, options and warrants were to be exercised or converted or otherwise resulted in the issuance of Common Stock that then
shared in the earnings of the entity.
Since the effects of outstanding
stock options, restricted stock units and warrants are anti-dilutive in the periods presented, shares of Common Stock underlying these
instruments have been excluded from the computation of loss per common share.
The following sets forth the
number of shares of Common Stock underlying outstanding stock options, restricted stock units and warrants that have been excluded from
the computation of loss per common share:
Schedule of antidilutive securities excluded from computation of earnings per share | |
| | | |
| | |
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | |
Stock options (1) | |
| 1,210,554 | | |
| 1,687,209 | |
Restricted stock units | |
| 2,500 | | |
| 4,167 | |
Warrants | |
| 676,649 | | |
| 676,649 | |
| |
| 1,889,703 | | |
| 2,368,025 | |
| (1) | The Company has excluded 100,000 and 333,333 stock options for the six months ended October 31, 2023 and
2022, respectively, with an exercise price of $0.006, from its anti-dilutive securities as these shares have been included in our determination
of basic loss per share as they represent shares issuable for little or no cash consideration upon the satisfaction of certain conditions
pursuant to FASB ASC 260-10-45-14. |
|
Recent Accounting Standards |
Recent Accounting Standards
From time to time, new accounting
pronouncements are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact
of recently issued standards that are not yet effective are not expected to have a material impact on the Company’s financial position
or results of operations upon adoption.
The Company has considered all other recently issued accounting standards
and does not believe the adoption of such standards will have a material impact on its condensed financial statements.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Oct. 31, 2023 |
Accounting Policies [Abstract] |
|
Schedule of antidilutive securities excluded from computation of earnings per share |
Schedule of antidilutive securities excluded from computation of earnings per share | |
| | | |
| | |
| |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | |
Stock options (1) | |
| 1,210,554 | | |
| 1,687,209 | |
Restricted stock units | |
| 2,500 | | |
| 4,167 | |
Warrants | |
| 676,649 | | |
| 676,649 | |
| |
| 1,889,703 | | |
| 2,368,025 | |
| (1) | The Company has excluded 100,000 and 333,333 stock options for the six months ended October 31, 2023 and
2022, respectively, with an exercise price of $0.006, from its anti-dilutive securities as these shares have been included in our determination
of basic loss per share as they represent shares issuable for little or no cash consideration upon the satisfaction of certain conditions
pursuant to FASB ASC 260-10-45-14. |
|
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v3.23.3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)
|
6 Months Ended |
Oct. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
Schedule of prepaid expenses and other current assets |
Schedule of prepaid expenses and other current assets | |
| | | |
| | |
| |
October 31, 2023 | | |
April 30, 2023 | |
Prepaid clinical trial fees | |
$ | 326,211 | | |
$ | 352,635 | |
Prepaid insurance | |
| 235,576 | | |
| 92,154 | |
Other prepaid expenses | |
| 20,015 | | |
| 2,800 | |
Total prepaid expenses and other current assets | |
$ | 581,802 | | |
$ | 447,589 | |
|
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v3.23.3
STOCK-BASED COMPENSATION (Tables)
|
6 Months Ended |
Oct. 31, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of share-based payment arrangement, option, activity |
Schedule of share-based payment arrangement, option, activity | |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | | |
Outstanding Options | |
| |
Shares Available for Grant | | |
Number of Shares | | |
Weighted Average Exercise Price | | |
Weighted Average Remaining Contractual Life (years) | | |
Aggregate Intrinsic Value | |
Balance at April 30, 2023 | |
| 612,778 | | |
| 987,222 | | |
$ | 18.96 | | |
| 6.18 | | |
$ | 819,900 | |
Options granted | |
| - | | |
| - | | |
$ | - | | |
| - | | |
| | |
Options exercised | |
| - | | |
| - | | |
$ | - | | |
| - | | |
| | |
Options expired | |
| 7,222 | | |
| (7,222 | ) | |
$ | 75.00 | | |
| - | | |
| | |
Balance at October 31, 2023 | |
| 620,000 | | |
| 980,000 | | |
$ | 18.96 | | |
| 5.72 | | |
$ | 174,500 | |
Options vested and expected to vest at October 31, 2023 | | |
| 913,334 | | |
$ | 17.83 | | |
| 5.47 | | |
$ | 174,500 | |
Options exercisable at October 31, 2023 | |
| | | |
| 895,679 | | |
$ | 17.39 | | |
| 4.37 | | |
$ | 174,500 | |
|
Schedule of Nonvested Restricted Stock Units Activity [Table Text Block] |
| | |
| | | |
| | |
| | |
Shares | | |
Weighted Average
Grant Date Fair Value | |
Unvested at April 30, 2023 | | |
| 3,333 | | |
$ | 2.50 | |
Granted | | |
| - | | |
| - | |
Vested | | |
| (833 | ) | |
| 2.50 | |
Cancelled | | |
| - | | |
| - | |
Unvested at October 31, 2023 | | |
| 2,500 | | |
$ | 2.50 | |
|
Schedule of stock-based compensation |
Schedule of stock-based compensation | |
| | |
| | |
| | |
| |
| |
For the Three Months Ended October 31, | | |
For the Six Months Ended October 31, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Research and development | |
$ | 142,603 | | |
$ | - | | |
$ | 142,603 | | |
$ | - | |
General and administrative | |
| 175,733 | | |
| 715,639 | | |
| 545,113 | | |
| 1,582,977 | |
Total stock-based compensation | |
$ | 318,336 | | |
$ | 715,639 | | |
$ | 687,716 | | |
$ | 1,582,977 | |
|
X |
- DefinitionTabular disclosure of share-based payment arrangement.
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v3.23.3
WARRANTS (Tables)
|
6 Months Ended |
Oct. 31, 2023 |
Warrants |
|
Schedule of common stock warrants outstanding |
Schedule of common stock warrants outstanding | |
| | | |
| | | |
| | |
| | | |
| | |
Outstanding | |
Exercisable | |
| |
| | |
Weighted | | |
| |
| | |
| |
| |
| | |
Average | | |
Weighted | |
| | |
Weighted | |
| |
| | |
Remaining | | |
Average | |
| | |
Average | |
Exercise | |
Number | | |
Contractual | | |
Exercise | |
Number | | |
Exercise | |
Price | |
Outstanding | | |
Life (years) | | |
Price | |
Exercisable | | |
Price | |
$15.00 | |
| 33,333 | | |
| 0.3 | | |
$ | 15.00 | |
| 33,333 | | |
$ | 15.00 | |
$26.25 | |
| 10,756 | | |
| 1.0 | | |
$ | 26.25 | |
| 10,756 | | |
$ | 26.25 | |
$45.00 | |
| 628,477 | | |
| 1.4 | | |
$ | 45.00 | |
| 628,477 | | |
$ | 45.00 | |
$93.75 | |
| 4,083 | | |
| 2.6 | | |
$ | 93.75 | |
| 4,083 | | |
$ | 93.75 | |
| |
| | | |
| | | |
| | |
| | | |
| | |
$15.00 - $93.75 | |
| 676,649 | | |
| 1.4 | | |
$ | 43.52 | |
| 676,649 | | |
$ | 43.52 | |
|
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v3.23.3
COMMITMENTS AND CONTINGENCIES (Tables)
|
6 Months Ended |
Oct. 31, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Schedule of contractual obligation, fiscal year maturity |
|
Schedule of contractual obligation, fiscal year maturity |
|
|
|
|
Payment |
|
Due Date |
|
Event |
$ |
50,000 |
* |
Completed September 2019 |
|
Pre-IND meeting |
|
|
|
|
|
|
$ |
65,000 |
* |
Completed June 2021 |
|
IND application filing |
|
|
|
|
|
|
$ |
190,000 |
* |
Completed December 2021 |
|
Upon first dosing of patient in a clinical trial |
|
|
|
|
|
|
$ |
500,000 |
* |
Completed March 2022 |
|
Upon completion of first clinical trial |
|
|
|
|
|
|
$ |
1,250,000 |
|
March 2025 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
10,000,000 |
|
8 years from the effective date of the agreement |
|
Upon FDA approval |
| * | Milestone met and completed |
ALZN002 License:
Payment |
|
Due Date |
$ |
50,000 |
* |
Completed January 2022 |
|
|
|
|
$ |
50,000 |
|
Upon first dosing of patient in first Phase I clinical trial |
|
|
|
|
$ |
500,000 |
|
Upon completion of first Phase IIb clinical trial |
|
|
|
|
$ |
1,000,000 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
$ |
10,000,000 |
|
Upon first commercial sale |
| * | Milestone met and completed |
Additional
AL001 Licenses:
Payment |
|
Due Date |
|
Event |
$ |
2,000,000 |
|
March 2026 |
|
Upon first patient treated in a Phase III clinical trial |
|
|
|
|
|
|
$ |
16,000,000 |
|
August 1, 2029 |
|
First commercial sale |
|
X |
- DefinitionTabular disclosure of contractual obligation by timing of payment due. Includes, but is not limited to, long-term debt obligation, lease obligation, and purchase obligation.
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v3.23.3
SIGNIFICANT ACCOUNTING POLICIES (Details) - shares
|
6 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
|
1,889,703
|
2,368,025
|
Equity Option [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
[1] |
1,210,554
|
1,687,209
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
|
2,500
|
4,167
|
Warrant [Member] |
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
|
676,649
|
676,649
|
|
|
X |
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v3.23.3
NOTE RECEIVABLE FOR COMMON STOCK, RELATED PARTY (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
|
Apr. 30, 2019 |
Oct. 31, 2023 |
Oct. 31, 2022 |
Oct. 31, 2023 |
Oct. 31, 2022 |
Apr. 30, 2023 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Number of shares purchase |
|
|
|
|
|
|
Warrant terms |
|
1 year 4 months 24 days
|
|
1 year 4 months 24 days
|
|
|
Outstanding receivable amount |
|
$ 14,876,293
|
|
$ 14,876,293
|
|
$ 14,883,295
|
Ault Life Sciences Fund L L C [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Number of shares purchase (in shares) |
666,666
|
|
|
|
|
|
Number of shares purchase |
$ 15,000,000
|
|
|
|
|
|
Ault Life Sciences Fund L L C [Member] | Securities Purchase Agreement [Member] | Warrant [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Number of warrants granted |
333,333
|
|
|
|
|
|
Warrant terms |
5 years
|
|
|
|
|
|
Exercise price (in dollars per share) |
$ 45.00
|
|
|
|
|
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v3.23.3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)
|
Oct. 31, 2023 |
Apr. 30, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid clinical trial fees |
$ 326,211
|
$ 352,635
|
Prepaid insurance |
235,576
|
92,154
|
Other prepaid expenses |
20,015
|
2,800
|
Total prepaid expenses and other current assets |
$ 581,802
|
$ 447,589
|
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v3.23.3
STOCK-BASED COMPENSATION (Details)
|
6 Months Ended |
Oct. 31, 2023
USD ($)
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Shares available for grant begining (in shares) |
612,778
|
Number of shares begining (in shares) |
987,222
|
Weighted average exercise price begining (in dollars per share) | $ / shares |
$ 18.96
|
Weighted average remaining contractual life begining (years) |
6 years 2 months 4 days
|
Aggregate intrinsic value begining | $ |
$ 819,900
|
Shares available for grant, Options granted |
|
Number of shares, Options granted |
|
Weighted average exercise price, Options granted | $ / shares |
|
Shares available for grant, Options exercised |
|
Number of shares, Options exercised |
|
Weighted average exercise price, Options exercised | $ / shares |
|
Shares available for grant, Options expired |
7,222
|
Number of shares, Options expired |
(7,222)
|
Weighted average exercise price, Options expired | $ / shares |
$ 75.00
|
Shares available for grant end (in shares) |
620,000
|
Number of shares end (in shares) |
980,000
|
Weighted average exercise price end (in dollars per share) | $ / shares |
$ 18.96
|
Weighted average remaining contractual life end (years) |
5 years 8 months 19 days
|
Aggregate intrinsic value end | $ |
$ 174,500
|
Number of shares, Options vested and expected to vest at end |
913,334
|
Weighted average exercise price, Options vested and expected to vest at end | $ / shares |
$ 17.83
|
Weighted average remaining contractual life, Options vested and expected to vest at end |
5 years 5 months 19 days
|
Aggregate intrinsic value, Options vested and expected to vest at end | $ |
$ 174,500
|
Number of shares, Options exercisable at end |
895,679
|
Weighted average exercise price, Options exercisable at end | $ / shares |
$ 17.39
|
Weighted average remaining contractual life, Options exercisable at end |
4 years 4 months 13 days
|
Aggregate intrinsic value, Options exercisable at end | $ |
$ 174,500
|
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v3.23.3
STOCK-BASED COMPENSATION (Details 1)
|
6 Months Ended |
Oct. 31, 2023
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Unvested shares, Beginning balance | shares |
3,333
|
Unvested Weighted Average Grant Date Fair Value, Beginning balance | $ / shares |
$ 2.50
|
Unvested shares, Granted | shares |
|
Unvested Weighted Average Grant Date Fair Value, Granted | $ / shares |
|
Unvested shares, Vested | shares |
(833)
|
Unvested Weighted Average Grant Date Fair Value, Vested | $ / shares |
$ 2.50
|
Unvested shares, Cancelled | shares |
|
Unvested Weighted Average Grant Date Fair Value, Cancelled | $ / shares |
|
Unvested shares, Ending balance | shares |
2,500
|
Unvested Weighted Average Grant Date Fair Value, Ending balance | $ / shares |
$ 2.50
|
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- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period.
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v3.23.3
STOCK-BASED COMPENSATION (Details 2) - USD ($)
|
3 Months Ended |
6 Months Ended |
Oct. 31, 2023 |
Oct. 31, 2022 |
Oct. 31, 2023 |
Oct. 31, 2022 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Stock-based compensation expense |
$ 318,336
|
$ 715,639
|
$ 687,716
|
$ 1,582,977
|
Research and Development Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Stock-based compensation expense |
142,603
|
|
142,603
|
|
General and Administrative Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Stock-based compensation expense |
$ 175,733
|
$ 715,639
|
$ 545,113
|
$ 1,582,977
|
X |
- DefinitionAmount of expense for award under share-based payment arrangement. Excludes amount capitalized.
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v3.23.3
STOCK-BASED COMPENSATION (Details Narrative) - shares
|
|
|
|
|
6 Months Ended |
Oct. 14, 2021 |
Nov. 26, 2019 |
Mar. 01, 2019 |
Apr. 30, 2016 |
Oct. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Options granted |
|
|
|
|
|
Perfromance Contingent Stock Options [Member] | Key Employees and Director [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Options granted |
|
283,333
|
|
|
|
Terms of award |
|
In the event any of
the stock price milestones are not achieved within three years
|
|
|
|
Perfromance Contingent Stock Options [Member] | Two Consultants [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Options granted |
13,333
|
|
|
|
|
Stock Incentive Plan2016 [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Share-based compensation arrangement by share-based payment award, number of shares authorized |
|
|
|
833,333
|
|
Share-based compensation arrangement by share-based payment award, number of additional shares authorized |
|
|
500,000
|
|
|
Stock Incentive Plan2016 [Member] | Maximum [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Share-based compensation arrangement by share-based payment award, expiration period |
|
|
|
10 years
|
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v3.23.3
WARRANTS (Details)
|
Oct. 31, 2023
$ / shares
shares
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Number warrant outstanding | shares |
676,649
|
Weighted average remaining contractual life (years) |
1 year 4 months 24 days
|
Warrant outstanding, weighted average exercise price (in dollars per share) |
$ 43.52
|
Number of warrant exercisable | shares |
676,649
|
Warrant exercisable, weighted average exercise price (in dollars per share) |
$ 43.52
|
Minimum [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercse price (in dollars per share) |
15.00
|
Maximum [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercse price (in dollars per share) |
93.75
|
15.00 [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercse price (in dollars per share) |
$ 15.00
|
Number warrant outstanding | shares |
33,333
|
Weighted average remaining contractual life (years) |
3 months 18 days
|
Warrant outstanding, weighted average exercise price (in dollars per share) |
$ 15.00
|
Number of warrant exercisable | shares |
33,333
|
Warrant exercisable, weighted average exercise price (in dollars per share) |
$ 15.00
|
26.25 [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercse price (in dollars per share) |
$ 26.25
|
Number warrant outstanding | shares |
10,756
|
Weighted average remaining contractual life (years) |
1 year
|
Warrant outstanding, weighted average exercise price (in dollars per share) |
$ 26.25
|
Number of warrant exercisable | shares |
10,756
|
Warrant exercisable, weighted average exercise price (in dollars per share) |
$ 26.25
|
45.00 [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercse price (in dollars per share) |
$ 45.00
|
Number warrant outstanding | shares |
628,477
|
Weighted average remaining contractual life (years) |
1 year 4 months 24 days
|
Warrant outstanding, weighted average exercise price (in dollars per share) |
$ 45.00
|
Number of warrant exercisable | shares |
628,477
|
Warrant exercisable, weighted average exercise price (in dollars per share) |
$ 45.00
|
93.75 [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Exercse price (in dollars per share) |
$ 93.75
|
Number warrant outstanding | shares |
4,083
|
Weighted average remaining contractual life (years) |
2 years 7 months 6 days
|
Warrant outstanding, weighted average exercise price (in dollars per share) |
$ 93.75
|
Number of warrant exercisable | shares |
4,083
|
Warrant exercisable, weighted average exercise price (in dollars per share) |
$ 93.75
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v3.23.3
COMMITMENTS AND CONTINGENCIES (Details)
|
6 Months Ended |
Oct. 31, 2023
USD ($)
|
Pre Ind Meeting [Member] | A L001 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 50,000
|
|
Due date |
Completed September 2019
|
[1] |
Ind Application Filing [Member] | A L001 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 65,000
|
|
Due date |
Completed June 2021
|
[1] |
Upon First Dosing of Patient in Clinical Trial [Member] | A L001 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 190,000
|
|
Due date |
Completed December 2021
|
[1] |
Upon Completion of First Clinical Trial [Member] | A L001 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 500,000
|
|
Due date |
Completed March 2022
|
[1] |
Upon First Patient Treated In A Phase III Clinical [Member] | A L001 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 1,250,000
|
|
Due date |
March 2025
|
|
Upon First Patient Treated In A Phase III Clinical [Member] | Additional A L001 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 2,000,000
|
|
Due date |
March 2026
|
|
Upon Fda Approval [Member] | A L001 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 10,000,000
|
|
Due date |
8 years from the effective date of the agreement
|
|
Upon IND Application Filing [Member] | ALZN002 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 50,000
|
|
Due date |
Completed January 2022
|
[2] |
Upon First Dosing Of Patient In First Phase I Clinical Trial [Member] | ALZN002 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 50,000
|
|
Due date |
Upon first dosing of patient in first Phase I clinical trial
|
|
Upon Completion Of First Phase II Clinical Trial [Member] | ALZN002 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 500,000
|
|
Due date |
Upon completion of first Phase IIb clinical trial
|
|
Upon First Patient Treated In Phase III Clinical Trial [Member] | ALZN002 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 1,000,000
|
|
Due date |
Upon first patient treated in a Phase III clinical trial
|
|
Upon FDA BLA Approval [Member] | ALZN002 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 10,000,000
|
|
Due date |
Upon first commercial sale
|
|
First Commercial Sale [Member] | Additional A L001 License [Member] |
|
|
Product Liability Contingency [Line Items] |
|
|
Payment |
$ 16,000,000
|
|
Due date |
August 1, 2029
|
|
|
|
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- DefinitionAmount of contractual obligation, including, but not limited to, long-term debt, lease obligation, purchase obligation, and other commitments.
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v3.23.3
EQUITY TRANSACTIONS (Details Narrative) - USD ($)
|
Apr. 30, 2019 |
Oct. 31, 2023 |
Apr. 30, 2023 |
Class of Stock [Line Items] |
|
|
|
Preferred stock, shares authorized |
|
10,000,000
|
10,000,000
|
Preferred stock, par value (in dollars per share) |
|
$ 0.0001
|
$ 0.0001
|
Warrant terms |
|
1 year 4 months 24 days
|
|
ALSF [Member] |
|
|
|
Class of Stock [Line Items] |
|
|
|
Shares purchase price |
$ 15,000,000
|
|
|
Warrant terms |
12 months
|
|
|
Securities Purchase Agreements [Member] | ALSF [Member] |
|
|
|
Class of Stock [Line Items] |
|
|
|
Number of shares purchase |
666,667
|
|
|
Shares purchase price |
$ 15,000,000
|
|
|
Shares purchase price (in dollars per share) |
$ 22.50
|
|
|
Securities Purchase Agreements [Member] | ALSF [Member] | Warrant [Member] |
|
|
|
Class of Stock [Line Items] |
|
|
|
Number of shares purchase |
333,333
|
|
|
Warrant terms |
5 years
|
|
|
Exercise price (in dollars per share) |
$ 45.00
|
|
|
Series A Preferred Stock [Member] |
|
|
|
Class of Stock [Line Items] |
|
|
|
Preferred stock, shares authorized |
|
8,640,000
|
|
Preferred stock, par value (in dollars per share) |
|
$ 0.0001
|
$ 0.0001
|
Preferred stock shares designated |
|
1,360,000
|
1,360,000
|
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v3.23.3
OTHER RELATED PARTY TRANSACTIONS (Details Narrative)
|
Nov. 30, 2022 |
Bitnile [Member] | Brand Development Agreement [Member] |
|
Related Party Transaction [Line Items] |
|
Related Party Transaction, Description of Transaction |
In November 2022, the Company
entered into a marketing and brand development agreement with Ault Alliance, Inc. (“AULT”), effective August 1, 2022, whereby
AULT will provide various marketing services over twelve months valued at $1.4 million. The Company had the right to pay the fee in cash
or shares of its common stock with a value of $22.50 per share. On November 11, 2022, the Company elected to pay the fee with 62,222 shares
of its common stock. The Company recorded the value of the agreement using the closing price of the Company’s common stock on November
11, 2022, and amortizes the expense over twelve months beginning in August 2022.
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