Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Alzamend Neuro, Inc.
Condensed Balance Sheets
(Unaudited)
January 31,
2024
April 30,
2023
ASSETS
CURRENT ASSETS
Cash
$ 282,867
$ 5,140,859
Prepaid expenses and other current assets
310,738
447,589
Prepaid expenses - related party
-
247,334
TOTAL CURRENT ASSETS
593,605
5,835,782
Property, plant and equipment, net
189,031
79,843
TOTAL ASSETS
$ 782,636
$ 5,915,625
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$ 3,826,457
$ 2,870,122
TOTAL CURRENT LIABILITIES
3,826,457
2,870,122
LONG-TERM LIABILITIES
Warrant liability
742,263
-
TOTAL LIABILITIES
4,568,720
2,870,122
COMMITMENTS AND CONTINGENCIES
MEZZANINE EQUITY
Series B Convertible Preferred Stock, $ 0.0001
stated value per share, 6,000
shares designated; 1,220
and nil 0 issued and outstanding as of January 31, 2024 and April 30, 2023, respectively
477,737
-
STOCKHOLDERS’ (DEFICIT) EQUITY
Series A Convertible Preferred Stock, $ 0.0001
stated value per share, 1,360,000
shares designated; nil 0 issued and outstanding as of January 31, 2024 and April 30, 2023
-
-
Common stock, $ 0.0001 par value: 300,000,000 shares authorized; 6,618,766 and 6,462,675 issued and outstanding as of January 31, 2024 and April 30, 2023, respectively
662
646
Additional paid-in capital
48,974,396
62,000,814
Note receivable for common stock – related party
-
( 14,883,295 )
Subscription receivable for preferred stock – related party
( 70,000 )
-
Accumulated deficit
( 53,168,879 )
( 44,072,662 )
TOTAL STOCKHOLDERS’ (DEFICIT) EQUITY
( 4,263,821 )
3,045,503
TOTAL LIABILITIES MEZZANINE AND STOCKHOLDERS’ (DEFICIT)
EQUITY
$ 782,636
$ 5,915,625
The accompanying notes are an integral part of these unaudited
condensed financial statements.
3
Alzamend Neuro, Inc.
Condensed Statements of Operations
(Unaudited)
For the Three Months Ended January 31,
For the Nine Months Ended January 31,
2024
2023
2024
2023
OPERATING EXPENSES
Research and development
$ 1,908,757
$ 2,888,847
$ 6,271,677
$ 5,797,789
General and administrative
751,173
2,534,665
2,815,904
5,767,668
Total operating expenses
2,659,930
5,423,512
9,087,581
11,565,457
Loss from operations
( 2,659,930 )
( 5,423,512 )
( 9,087,581 )
( 11,565,457 )
OTHER EXPENSE, NET
Interest expense
( 2,488 )
( 2,062 )
( 8,636 )
( 7,182 )
Total other expense, net
( 2,488 )
( 2,062 )
( 8,636 )
( 7,182 )
NET LOSS
$ ( 2,662,418 )
$ ( 5,425,574 )
$ ( 9,096,217 )
$ ( 11,572,639 )
Basic and diluted net loss per common share
$ ( 0.38 )
$ ( 0.83 )
$ ( 1.35 )
$ ( 1.78 )
Basic and diluted weighted average common shares outstanding
7,054,319
6,555,078
6,726,926
6,517,698
The accompanying notes are an integral part of these unaudited
condensed financial statements.
4
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’ Deficit
For the Three Months Ended January 31, 2024
(Unaudited)
Series A Convertible
Additional
Note Receivable for
Subscription Receivable
Preferred Stock
Common Stock
Paid-In
Common Stock -
for Preferred Stock -
Accumulated
Shares
Amount
Shares
Amount
Capital
Related Party
Related Party
Deficit
Total
BALANCES, October 31, 2023
-
$ - -
6,469,657
$ 647
$ 62,699,614
$ ( 14,876,293 )
$ -
$ ( 50,506,461 )
$ ( 2,682,493 )
Issuance of common stock for cash
-
-
810,277
81
964,369
-
-
964,450
Subscription receivable for issuance of preferred stock - related party
-
-
-
-
-
-
( 70,000 )
-
( 70,000 )
Return of common stock for note receivable - related party
-
-
( 661,168 )
( 66 )
( 14,876,227 )
14,876,293
-
-
-
Stock-based compensation to employees and consultants
-
-
-
-
186,640
-
-
-
186,640
Net loss
-
- -
-
-
-
-
-
( 2,662,418 )
( 2,662,418 )
BALANCES, January 31, 2024
-
$ - -
6,618,766
$ 662
$ 48,974,396
$ -
$ ( 70,000 )
$ ( 53,168,879 )
$ ( 4,263,821 )
The accompanying notes are an integral part of these unaudited
condensed financial statements.
5
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’ Equity
For the Three Months Ended January 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, October 31, 2022
-
$ -
6,366,286
$ 637
$ 59,011,641
$ ( 14,883,295 )
$ ( 35,341,560 )
$ 8,787,423
Issuance of common stock for related party payable
-
-
62,222
6
989,328
-
-
989,334
Stock-based compensation to employees and consultants
-
-
-
-
1,508,322
-
-
1,508,322
Net loss
-
-
-
-
-
-
( 5,425,574 )
( 5,425,574 )
BALANCES, January 31, 2023
-
$ -
6,428,508
$ 643
$ 61,509,291
$ ( 14,883,295 )
$ ( 40,767,134 )
$ 5,859,505
The accompanying notes are an integral part of these unaudited
condensed financial statements.
6
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’ (Deficit) Equity
For the Nine Months Ended January 31, 2024
(Unaudited)
Series A Convertible
Additional
Note Receivable for
Subscription Receivable
Preferred Stock
Common Stock
Paid-In
Common Stock -
for Preferred Stock -
Accumulated
Shares
Amount
Shares
Amount
Capital
Related Party
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
-
-
816,426
82
982,455
-
-
-
982,537
Issuance of common stock for restricted stock awards
-
-
833
-
-
-
-
-
-
Subscription receivable for issuance of preferred stock – related party
-
-
-
-
-
-
( 70,000 )
-
( 70,000 )
Subscription receivable payment received – related party
-
-
-
-
( 7,002 )
7,002
-
-
-
Return of common stock for note receivable – related party
-
-
( 661,168 )
( 66 )
( 14,876,227 )
14,876,293
-
-
-
Stock-based compensation to employees and consultants
-
-
-
-
874,356
-
-
-
874,356
Net loss
-
-
-
-
-
-
-
( 9,096,217 )
( 9,096,217 )
BALANCES, January 31, 2024
-
$ -
6,618,766
$ 662
$ 48,974,396
$ -
$ ( 70,000 )
$ ( 53,168,879 )
$ ( 4,263,821 )
The accompanying notes are an integral part of these unaudited
condensed financial statements.
7
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’ Equity
For the Nine Months Ended January 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, 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
-
-
-
-
-
Stock-based compensation to employees and consultants
-
-
-
-
3,091,299
-
-
3,091,299
Issuance of common stock for related party payable
-
-
62,222
6
989,328
-
-
989,334
Net loss
-
-
-
-
-
-
( 11,572,639 )
( 11,572,639 )
BALANCES, January 31, 2023
-
$ -
6,428,508
$ 643
$ 61,509,291
$ ( 14,883,295 )
$ ( 40,767,134 )
$ 5,859,505
The accompanying notes are an integral part of these unaudited
condensed financial statements.
8
Alzamend Neuro, Inc.
Condensed Statements of Cash Flows
(Unaudited)
For the Nine Months Ended January 31,
2024
2023
Cash flows from operating activities:
Net loss
$ ( 9,096,217 )
$ ( 11,572,639 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
38,055
17,743
Stock-based compensation to employees and consultants
874,356
3,091,299
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
136,851
( 196,580 )
Prepaid expenses - related party
247,334
492,584
Accounts payable and accrued liabilities
956,335
1,479,623
Net cash used in operating activities
( 6,843,286 )
( 6,687,970 )
Cash flows from investing activities:
Purchase of machinery
( 147,243 )
-
Net cash used in investing activities
( 147,243 )
-
Cash flows from financing activities:
Proceeds from the issuance of common stock, net
982,537
-
Proceeds from the issuance of preferred stock - related party
1,150,000
-
Net cash provided by financing activities
2,132,537
-
Net decrease in cash
( 4,857,992 )
( 6,687,970 )
Cash at beginning of period
5,140,859
14,063,811
Cash at end of period
$ 282,867
$ 7,375,841
Supplemental disclosures of cash flow information:
Non-cash financing activities:
Return of common stock for note receivable – related party
$ ( 14,883,295 )
$ -
Issuance of preferred stock for subscription receivable - related party
$ 70,000
$ -
Fair value of warrants issued in connection with preferred stock –
related party
$ 742,263
$ -
Issuance of common stock for related party payable
$ -
$ 989,334
The accompanying notes are an integral part of these unaudited
condensed financial statements.
9
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”) and its preferred stock, par value $ 0.0001 per share. 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 January 31, 2024, the Company had cash of $ 283,000 ,
a working capital deficiency of $ 3.2 million, an accumulated deficit of $ 53.2 million and stockholders’ deficit of $ 4.3 million.
For the three and nine months ended January 31, 2024, the Company had net losses of $ 2.7 million and $ 9.1 million, respectively. For the
nine months ended January 31, 2024, cash used in operating activities was $ 6.8 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 its 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). 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. As previously disclosed the Company had anticipated beginning Phase II clinical trials for AL001
additional indications in the first quarter of calendar 2024. Due to the Company’s inability to obtain significant additional financing,
the Company has been unable to initiate those clinical trials and reduce its capital deficiency.
10
During
the period between February 1, 2024 through March 22, 2024, the Company sold an aggregate of 248,080 shares of Common Stock pursuant
to an “at the market offering” (the “ATM Offering”), as defined in Rule 415 under the Securities Act of
1933, as amended (the “Securities Act”), for gross proceeds of $ 266,000 (Note 9).
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 January 31, 2024 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.
11
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 (“ASC 815”) , 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 Nine Months Ended January 31,
2024
2023
Stock options (1)
1,210,554
1,210,554
Restricted stock units
2,500
4,167
Warrants
1,563,316
676,649
2,776,370
1,891,370
(1) The Company has excluded 100,000 stock options for the nine months ended January 31, 2024 and 2023, 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.
12
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 (“ALSF Warrants”). 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 was secured
by a pledge of the purchased shares. As the note receivable from ALSF was related to the issuance of Common Stock, it was recorded as
an offset to additional paid-in capital. ALSF is wholly owned by Ault Life Sciences, Inc. (“ALSI”). ALSI is majority owned
by Ault & Company, Inc. (“Ault & Co.”). Messrs. Ault, Horne and Nisser, directors of the Company, are also directors
of Ault & Co.
On January 19, 2024, the Company and ALSF
entered into a settlement agreement and release of claims whereby ALSF returned to the Company 661,168 shares of Common Stock and the
ALSF Warrants for settlement of the outstanding balance of the note receivable in the amount of $ 14,876,293 .
5. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets
were as follows:
Schedule of prepaid expenses and other current assets
January 31, 2024
April 30, 2023
Prepaid clinical trial fees
$ 149,595
$ 352,635
Prepaid insurance
148,049
92,154
Other prepaid expenses
13,094
2,800
Total prepaid expenses and other current assets
$ 310,738
$ 447,589
Prepaid clinical trial fees at January 31,
2024 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 January 31, 2024 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.
13
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
nine months ended January 31, 2024 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 January 31, 2024
620,000
980,000
$ 18.96
5.47
$ 85,400
Options vested and expected to vest at January 31, 2024
913,334
$ 17.83
5.22
$ 85,400
Options exercisable at January 31, 2024
897,523
$ 17.62
5.17
$ 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 nine
months ended January 31, 2024 is presented below:
Schedule of nonvested restricted stock units activity
Shares
Weighted Average
Grant Date Fair Value
Unvested at April 30, 2023
3,333
$ 2.50
Granted
-
-
Vested
( 833 )
2.50
Cancelled
-
-
Unvested at January 31, 2024
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%.
14
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 January 31, 2024, 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 January 31, 2024, 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 January 31, 2024, 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 nine months ended January 31,
2024, the Company filed INDs for BD and MDD and received a “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. During the three months ended January 31, 2024, the Company filed an IND for PTSD and received
a “Study May Proceed” letter. As a result, 25% of the performance grant vested and the Company recognized stock-based compensation
related to the vesting of achieving the PTSD criteria. As of January 31, 2024, 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 ALZN002 – Alzheimer’s disease.
15
Stock-Based Compensation Expense
The Company’s results of operations
included expenses relating to stock-based compensation for three and nine months ended January 31, 2024 and 2023 comprised as follows:
Schedule of stock-based
compensation
For the Three Months Ended January 31,
For the Nine Months Ended January 31,
2024
2023
2024
2023
Research and development
$ 71,302
$ ( 42,589 )
$ 213,905
$ ( 42,589 )
General and administrative
115,338
1,550,911
660,451
3,133,888
Total
$ 186,640
$ 1,508,322
$ 874,356
$ 3,091,299
As of January 31, 2024, total unamortized
stock-based compensation expense related to unvested employee and non-employee awards that are expected to vest was $ 418,000 . The weighted-average
period over which such stock-based compensation expense will be recognized was approximately 1.6 years.
7. WARRANTS
On January 31, 2024, the Company issued a warrant to purchase 1,220,000
shares of Common Stock at an exercise price of $1.20 in connection with the sale of convertible preferred stock to Ault Lending for $1,220,000.
Based on the terms of the Company’s warrant agreement, the Company accounted for the warrant as a liability.
The following table summarizes information
about Common Stock warrants outstanding and exercisable at January 31, 2024:
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
$ 1.20
1,220,000
5.5
$ 1.20
-
-
$ 15.00
33,333
0.1
$ 15.00
33,333
$ 15.00
$ 26.25
10,756
0.8
$ 26.25
10,756
$ 26.25
$ 45.00
295,144
2.1
$ 45.00
295,144
$ 45.00
$ 93.75
4,083
2.4
$ 93.75
4,083
$ 93.75
$ 1.20 - $ 93.75
1,563,316
4.7
$ 10.18
343,316
$ 10.18
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.
16
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
17
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
9. 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 Series
A Convertible Preferred Stock and 6,000 shares as Series B Convertible Preferred Stock. The rights, preferences, privileges and restrictions
on the remaining authorized 8,634,000 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 January 31, 2024, there
were no shares of Series A Convertible Preferred Stock issued or outstanding.
Series B Convertible
Preferred Stock
On January 31, 2024, the
Company and Ault Lending, entered into a securities purchase agreement (the “AL SPA”) for the purchase of up to 6,000 shares
of Series B Convertible Preferred Stock and warrants to purchase shares up to 6,000,000 shares of the Company’s Common Stock. The
AL SPA provides that Ault Lending may purchase up to $6 million of Series B Convertible Preferred Stock in one or more closings. Ault
Lending has the right to purchase up to $2 million of Series B Convertible Preferred Stock, on or before March 31, 2024, and the right
to purchase up to $4 million of Series B Convertible Preferred Stock after March 31, 2024, but on or before March 31, 2025 (the “Termination
Date”). The Agreement will automatically terminate if the final closing has not occurred prior to the Termination Date.
On January 31, 2024, the Company
sold 1,220 shares of Series B Convertible Preferred Stock and warrants to purchase 1,220,000 shares of Common Stock with an exercise price
of $ 1.20 , for a total purchase price of $ 1.22 million. The purchase price was paid by the cancellation
of $ 1.15 million of cash advances made by Ault Lending to the Company between November 9, 2023 and January 31, 2024 and a subscription
receivable of $ 70,000 .
The Series B Convertible
Preferred Stock has a stated value of $1,000 per share (“Stated Value”) and does not
accrue dividends. Each share of Series B Convertible Preferred Stock is convertible into a number of shares of Common Stock determined
by dividing the Stated Value by $1.00 (the “Conversion Price”). The Conversion Price is subject to adjustment in the
event of an issuance of Common Stock at a price per share lower than the Conversion Price then in effect, as well as upon customary stock
splits, stock dividends, combinations or similar events. The holders of the Series B Convertible Preferred Stock are entitled to vote
with the Common Stock as a single class on an as-converted basis, subject to applicable law provisions of the Delaware General Company
Law and Nasdaq, provided however, that for purposes of complying with Nasdaq regulations, the conversion price, for purposes of determining
the number of votes the holder of Series B Convertible Preferred Stock is entitled to cast, shall not be lower than $0.873 (the “Voting
Floor Price”), which represents the closing sale price of the Common Stock on the trading day immediately prior to the Execution
Date. The Voting Floor Price shall be adjusted for stock dividends, stock splits, stock combinations and other similar transactions. Upon
a liquidation event the holders of Series B Convertible Preferred Stock receive a liquidation preference ahead of Common Stock holders.
18
The warrants have an exercise
price of $1.20 (the “Exercise Price”) and become exercisable on the first business day after the six-month anniversary of
issuance (the “Initial Exercise Date”) and have a five-year term, expiring on the fifth anniversary of the Initial Exercise
Date. The Exercise Price is subject to adjustment in the event of an issuance of Common Stock at a price per share lower than the Exercise
Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events.
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 was secured by a pledge of the purchased shares. Pursuant to the SPA, ALSF was 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 was secured by a pledge of the purchased shares. On January
19, 2024, the Company and ALSF entered into a settlement agreement and release of claims whereby ALSF returned to the Company 661,168
shares of Common Stock and the ALSF Warrants for settlement of the outstanding balance of the note receivable in the amount of $ 14,876,293 .
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 the ATM Offering. 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 nine months ended January 31,
2024, the Company sold an aggregate of 816,426 shares of Common Stock pursuant to the ATM Offering for gross proceeds of $1.0 million
and net proceeds of $ 983,000 .
In accordance with Nasdaq
listing rule 5810(c)(3)(A), the Company has 180 calendar days, or until July 30, 2024, to regain compliance. The Deficiency Letter states
that to regain compliance, the bid price for the Common Stock must close at $1.00 per share or more (the “Minimum Bid Price”)
for a minimum of 10 consecutive business days during the compliance period ending July 30, 2024. In the event that the Company does not
regain compliance within this 180-day period, the Company may be eligible to seek an additional compliance period of 180 calendar days
if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the
Nasdaq Capital Market, with the exception of the Minimum Bid Price, and provides written notice to Nasdaq of its intent to cure the deficiency
during this second compliance period, by effecting a reverse stock split, if necessary. However, if it appears to the Nasdaq Staff that
the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice to the Company
that its Common Stock will be subject to delisting. At that time, the Company may appeal any such delisting determination to a Nasdaq
hearings panel.
The Deficiency Letter has
no immediate effect on the listing of the Common Stock, and the Common Stock continues to trade on the Nasdaq Capital Market under the
symbol “ALZN.”
The Company intends to actively
monitor the closing bid price for the Common Stock between now and July 30, 2024, and may, if appropriate, evaluate available options
to resolve the deficiency and regain compliance with the Minimum Bid Price requirement. While the Company is exercising diligent efforts
to maintain the listing of its Common Stock on Nasdaq, there can be no assurance that the Company will be able to regain compliance with
the Minimum Bid Price or maintain compliance with the other Nasdaq listing standards.
19
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 January 31, 2024, the balance of related party prepaid
expenses was zero.
11. SUBSEQUENT EVENTS
During
the period between February 1, 2024 through March 22, 2024, the Company sold an aggregate of 248,080 shares of Common Stock pursuant
to the ATM Offering for gross proceeds of $ 266,000 .
On March 21, 2024, the Company amended its Amended and Restated Certificate
of Designations for its Series B Convertible Preferred Stock to remove certain change of control language.
On March 21, 2024, the Company and Ault Lending amended the warrant
issued to Ault Lending as part of the AL SPA to remove certain anti-dilution language.
20
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.