Item 1. Financial Statements
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.
3
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.
4
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.
5
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.
6
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
Issuance of common stock for restricted stock awards
-
-
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 )
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.
7
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.
8
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.
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”). 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.
10
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.
11
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.
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. 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.
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 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%.
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 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
15
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.
7. WARRANTS
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.
16
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
17
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 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.
11. 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.
18
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.