Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS
Alzamend Neuro, Inc.
Condensed Balance Sheets
(Unaudited)
January 31, 2023
April 30, 2022
ASSETS
CURRENT ASSETS
Cash
$ 7,375,841
$ 14,063,811
Prepaid expenses and other current assets
546,303
349,723
Prepaid expenses - related party
494,668
-
TOTAL CURRENT ASSETS
8,416,812
14,413,534
Property, plant and equipment, net
85,166
102,909
TOTAL ASSETS
$ 8,501,978
$ 14,516,443
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$ 2,642,473
$ 1,162,850
Related party payable
-
2,082
TOTAL CURRENT LIABILITIES
2,642,473
1,164,932
TOTAL LIABILITIES
2,642,473
1,164,932
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ 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 January 31, 2023 and April 30, 2022
-
-
Common stock, $ 0.0001 par value: 300,000,000 shares authorized; 96,427,624 and 95,481,790 shares issued and outstanding as of
January 31, 2023 and April 30, 2022, respectively
9,642
9,548
Additional paid-in capital
61,500,292
57,419,753
Note receivable for common stock – related party
( 14,883,295 )
( 14,883,295 )
Accumulated deficit
( 40,767,134 )
( 29,194,495 )
TOTAL STOCKHOLDERS’ EQUITY
5,859,505
13,351,511
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 8,501,978
$ 14,516,443
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,
2023
2022
2023
2022
OPERATING EXPENSES
Research and development
$ 2,888,847
$ 873,653
$ 5,797,789
$ 3,540,111
General and administrative
2,534,665
1,682,913
5,767,668
4,906,628
Total operating expenses
5,423,512
2,556,566
11,565,457
8,446,739
Loss from operations
( 5,423,512 )
( 2,556,566 )
( 11,565,457 )
( 8,446,739 )
OTHER EXPENSE, NET
Interest expense
( 2,062 )
( 16,299 )
( 7,182 )
( 45,922 )
Total other expense, net
( 2,062 )
( 16,299 )
( 7,182 )
( 45,922 )
NET LOSS
$ ( 5,425,574 )
$ ( 2,572,865 )
$ ( 11,572,639 )
$ ( 8,492,661 )
Basic and diluted net loss per common share
$ ( 0.06 )
$ ( 0.03 )
$ ( 0.12 )
$ ( 0.09 )
Basic and diluted weighted average common shares outstanding
98,326,175
94,165,225
97,765,471
89,484,601
The accompanying notes are an integral part of these unaudited
condensed financial statements.
4
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
-
$ -
95,494,290
$ 9,549
$ 59,002,729
$ ( 14,883,295 )
$ ( 35,341,560 )
$ 8,787,423
Stock-based compensation to employees and consultants
-
-
-
-
1,508,322
-
-
1,508,322
Issuance of common stock for related party payable
-
-
933,334
93
989,241
-
-
989,334
Net loss
-
-
-
-
-
-
( 5,425,574 )
( 5,425,574 )
BALANCES, January 31, 2023
-
$ -
96,427,624
$ 9,642
$ 61,500,292
$ ( 14,883,295 )
$ ( 40,767,134 )
$ 5,859,505
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, 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, October 31, 2021
-
$ -
88,850,358
$ 8,885
$ 50,652,054
$ ( 14,883,295 )
$ ( 22,752,233 )
$ 13,025,411
Stock-based compensation to employees and consultants
-
-
-
-
1,130,795
-
-
1,130,795
Proceeds from stock option exercise
-
-
1,000,000
100
300
-
-
400
Issuance of share of common stock for conversion of debt
-
-
252,265
25
378,373
-
-
378,398
Net loss
-
-
-
-
-
-
( 2,572,865 )
( 2,572,865 )
BALANCES, January 31, 2022
-
$ -
90,102,623
$ 9,010
$ 52,161,522
$ ( 14,883,295 )
$ ( 25,325,098 )
$ 11,962,139
The accompanying notes are an integral part of these unaudited
condensed financial statements.
6
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
-
$ -
95,481,790
$ 9,548
$ 57,419,753
$ ( 14,883,295 )
$ ( 29,194,495 )
$ 13,351,511
Issuance of common stock for restricted stock awards
-
-
12,500
1
( 1 )
-
-
-
Stock-based compensation to employees and consultants
-
-
-
-
3,091,299
-
-
3,091,299
Issuance of common stock for related party payable
-
-
933,334
93
989,241
-
-
989,334
Net loss
-
-
-
-
-
-
( 11,572,639 )
( 11,572,639 )
BALANCES, January 31, 2023
-
$ -
96,427,624
$ 9,642
$ 61,500,292
$ ( 14,883,295 )
$ ( 40,767,134 )
$ 5,859,505
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, 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, 2021
750,000
$ 75
67,429,525
$ 6,743
$ 33,721,859
$ ( 14,883,295 )
$ ( 16,832,437 )
$ 2,012,945
Issuance of common stock for restricted stock awards
-
-
212,500
21
( 21 )
-
-
-
Stock-based compensation to employees and consultants
-
-
-
-
3,150,801
-
-
3,150,801
Proceeds from sale of common stocks & warrants-related party
-
-
1,333,333
133
1,999,867
-
-
2,000,000
Proceeds from stock option exercise
-
-
3,000,000
300
900
-
-
1,200
Proceeds from initial public offering, net of underwriters' discounts and commissions and issuance costs of $1.5 million
-
-
2,875,000
288
12,911,168
-
-
12,911,456
Issuance of shares of common stock for conversion of debt
-
-
252,265
25
378,373
378,398
Conversion of Series A convertible stock
( 750,000 )
( 75 )
15,000,000
1,500
( 1,425 )
-
-
-
Net loss
-
-
-
-
-
-
( 8,492,661 )
( 8,492,661 )
BALANCES, January 31, 2022
-
$ -
90,102,623
$ 9,010
$ 52,161,522
$ ( 14,883,295 )
$ ( 25,325,098 )
$ 11,962,139
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,
2023
2022
Cash flows from operating activities:
Net loss
$ ( 11,572,639 )
$ ( 8,492,661 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
17,743
-
Interest expense - debt discount
-
12,770
Stock-based compensation to employees and consultants
3,091,299
3,150,801
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 196,580 )
344,493
Prepaid expenses related party
492,584
-
Accounts payable and accrued expenses
1,479,623
( 67,040 )
Net cash used in operating activities
( 6,687,970 )
( 5,051,637 )
Cash flows from financing activities:
Proceeds from the issuance of common stock and warrants - related party, net
-
2,000,000
Proceeds from stock option exercise
-
1,200
Proceeds from initial public offering, net of underwriters’ discounts and commissions and issuance costs
-
12,911,456
Net cash provided by financing activities
-
14,912,656
Net (decrease) increase in cash
( 6,687,970 )
9,861,019
Cash at beginning of period
14,063,811
1,929,270
Cash at end of period
$ 7,375,841
$ 11,790,289
Supplemental disclosures of cash flow information:
Non-cash financing activities:
Fair value of warrants issued in connection with March 2021 securities purchase agreement, related party
$ -
$ 4,799,742
Fair value of warrants issued in connection with IPO
$ -
$ 461,877
Issuance of common stock on conversion of note
$ -
$ 378,373
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 an early 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 the Company’s two current product candidates, Alzamend aims to bring
treatments or cures to market as quickly as possible. The Company’s current pipeline consists of two novel therapeutic drug candidates
(collectively, the “Technology”): (i) a patented ionic cocrystal technology delivering a therapeutic combination of lithium,
proline and salicylate, for the treatment of Alzheimer’s BD, MDD and PTSD, 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 Technology. 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.
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, 2023, the Company had cash of $ 7.4
million and an accumulated deficit of $ 40.8 million. The Company incurred losses for the three and nine months ended January 31, 2023
totaling $ 5.4 million and $ 11.6 million, respectively. Historically, the Company has financed its operations principally through issuances
of equity and debt instruments.
The Company expects to continue to
incur losses for the foreseeable future and needs to raise additional capital until it is able to generate revenues from operations sufficient
to fund its development and commercial operations. However, based on the Company’s current business plan, management believes that
the Company’s cash at January 31, 2023 is sufficient to meet the Company’s anticipated cash requirements during the twelve-month
period subsequent to the issuance of the financial statements included in this Quarterly Report.
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 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, 2022, filed with the SEC on July 19, 2022. In
the opinion of management, the accompanying condensed interim financial statements include all adjustments necessary in order to make
the 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 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, 2022 has been derived from the audited balance sheet
at April 30, 2022 contained in such Form 10-K.
10
Accounting Estimates
The preparation of 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 financial statements and the reported amounts of expenses during
the reporting period. The Company’s critical 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, 2023 and April 30,
2022, 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 conversion option and warrants and the risk free
interest rate based on the implied yield available on U.S. Treasury Securities with a maturity equivalent to the warrants’ contractual
life.
Property and Equipment, Net
Property and equipment are stated at cost,
net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life of five years.
Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred.
Research and Development Expenses
Research and development costs are expensed
as incurred. Research and development costs consist of scientific consulting fees 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.
11
The Company recognizes stock-based compensation
expense for restricted stocks 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 ASC 480, Distinguishing Liabilities from
Equity and 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 options,
warrants, convertible preferred stock and convertible notes 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 options 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,
2023
2022
Stock options (1)
18,158,329
13,500,000
Warrants
10,149,788
8,830,785
28,308,117
22,330,785
(1) The Company has excluded 2,000,000 and 4,500,000 stock options for the nine months ended January 31, 2023
and 2022, respectively, with an exercise price of $ 0.0004 , 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 ASC 260-10-45-14.
Recent Accounting Standards
From time to time, new accounting pronouncements
are issued by the FASB and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently
issued standards that are not yet effective are not expected to have a material impact on the Company’s financial position or results
of operations upon adoption.
The Company has considered all other recently
issued accounting standards and does not believe the adoption of such standards will have a material impact on its 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 10,000,000 shares of Common
Stock for a total purchase price of $ 15,000,000 , or $1.50 per share with 5,000,000 warrants with a 5 -year life and an exercise price of
$ 3.00 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 January 31, 2023 and April 30, 2022, the outstanding balance of the note receivable was $ 14,883,295 . 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.
12
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, 2023
April 30, 2022
Prepaid clinical trial fees
$ 315,987
$ -
Prepaid insurance
222,742
155,880
Other prepaid expenses
7,574
7,176
Prepaid consulting fees
-
186,667
Total prepaid expenses and other current assets
$ 546,303
$ 349,723
On January 5, 2023, the Company prepaid
$ 437,466 for clinical trial fees related to AL002.
Prepaid clinical trial fees at January 31, 2023, represented the unused portion of the prepaid clinical fees. On June 16, 2022, the Company
purchased directors and officers (“D&O”) insurance for 12 months in the amount of $ 492,000 .
Prepaid insurance at January 31, 2023 represented the unamortized portion of the annual insurance premium.
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 12,500,000
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 7,500,000
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 5 and 10
years from the date of grant. Restricted stock awards granted under the Plan are subject to a vesting period determined at the date
of grant.
2021 Stock Incentive Plan
In February 2021, the Company’s board
of directors (the “Board”) adopted, and the stockholders approved, the Alzamend Neuro, Inc. 2021 Stock Incentive Plan (the
“2021 Plan”). The 2021 Plan authorizes the grant to eligible individuals of (1) stock options (incentive and non-statutory),
(2) restricted stock, (3) stock appreciation rights, or SARs, (4) restricted stock units, and (5) other stock-based compensation.
Stock Subject to the 2021 Plan. The
maximum number of shares of Common Stock that may be issued under the 2021 Plan is 10,000,000 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.
13
A summary of stock option activity for
the nine months ended January 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, 2022
8,800,000
15,700,000
$
1.16
6.32
$
2,219,700
Options granted
( 2,000,000 )
2,000,000
$
1.17
9.83
Options exercised
-
-
$
-
-
Options expired
2,391,671
( 2,391,671
)
$
1.34
-
Balance at January 31, 2023
9,191,671
15,308,329
$
1.18
6.32
$
1,327,200
Options vested and expected to vest at January 31, 2023
14,308,329
$
1.18
6.07
$
1,327,200
Options exercisable at January 31, 2023
13,172,907
$
1.11
5.91
$
1,327,200
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.
Stock Options Granted to Employees and Consultants
The estimated fair value of stock options
granted to employees and consultants during the nine months ended January 31, 2023 and 2022 were calculated using the Black-Scholes option-pricing
model using the following assumptions:
Schedule of stock options granted to employees and consultants
For the Nine Months Ended January 31,
2023
2022
Expected term (in years)
6.25
3.50 – 6.25
Volatility
88.94 %
85.53 % - 87.10 %
Risk-free interest rate
3.89 %
1.01 %- 1.07 %
Dividend yield
0.0 %
0.0 %
Expected Term: The expected
term represents the period that the options granted are expected to be outstanding and is determined using the simplified method (based
on the mid-point between the vesting date and the end of the contractual term).
Expected Volatility: The Company
uses an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry
that were deemed to be representative of future stock price trends as the Company did not have sufficient trading history for its Common
Stock at January 31, 2023 and 2022. The Company will continue to apply this process until a sufficient amount of historical information
regarding the volatility of its own stock price becomes available.
Risk-Free Interest Rate: The
Company based the risk-free interest rate over the expected term of the options based on the constant maturity rate of U.S. Treasury securities
with similar maturities as of the date of the grant.
Expected Dividend: The Company
has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected dividend yield was zero.
Stock-based compensation to employees and
consultants from stock option grants for the nine months ended January 31, 2023 and 2022, was $ 3.1 million and $ 3.2 million, respectively.
Performance Contingent Stock Options
Granted to Employee
On November 26, 2019, the Board granted
4,250,000 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 $1.50 per share. These awards have multiple separate market triggers for vesting based upon either
(i) the successful achievement of stepped 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) stepped target prices
for a change in control transaction. The target prices range from $10 per share to $40 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 $10 per share to $20 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
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, 2023, the Company believes that the achievement of the requisite performance conditions is
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
2,000,000 performance-based stock option to the Chief Executive Officer at an exercise price of $1.17 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 II clinical trial
of ALZN002 within four years from the grant date. As of January 31, 2023, the Company believes that it is probable that the performance
condition of the completion and announcement of topline data from the Company’s Phase II clinical trial of AL001 will be achieved
and has recognized the related stock-based compensation. As of January 31, 2023, the Company believes that the achievement of the second
performance condition is not probable and, as a result, no compensation cost has been recognized related to Phase II of ALZN002.
Performance Contingent Stock Options
Granted to TAMM Net
On March 23, 2021, the Company issued performance-based
stock options to the certain team members at TAMM Net, Inc. (“TAMM Net”) to purchase an aggregate of 450,000 shares of Common
Stock at a per share exercise price of $1.50 per share, of which 50% vest upon the completion of Phase I of AL001 by March 31, 2022, and
the remaining 50% vest upon completion of Phase I 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 for ALZN002, as of January 31, 2023, the Company believes that the achievement of
the requisite performance conditions is 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 200,000 shares of Common Stock with an exercise price of
$2.42 per share, of which 50,000 vest upon completion of each of the Phase II clinical trials of AL001 for a Bipolar indication, AL001
for a PTSD indication, AL001 for a depression 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 for the
additional 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.
As of January 31, 2023, the Company believes
that the achievement of the requisite performance conditions is not probable and, as a result, no compensation cost has been recognized
for these awards related to Phase II of AL001 and ALZN002.
Stock-Based Compensation Expense
The Company’s results of operations
include expenses relating to stock-based compensation for three and nine months ended January 31, 2023 and 2022, that were comprised
as follows:
Schedule of stock-based compensation
For the Three Months Ended January 31,
For the Nine Months Ended January 31,
2023
2022
2023
2022
Research and development
$ ( 42,589 )
$ 106,102
$ ( 42,589 )
$ 359,286
General and administrative
1,550,911
1,024,693
3,133,888
2,791,515
Total
$ 1,508,322
$ 1,130,795
$ 3,091,299
$ 3,150,801
15
As of January 31, 2023, total unamortized
stock-based compensation expense related to unvested employee and non-employee awards that are expected to vest was $ 1.5
million. The weighted-average period over which such stock-based compensation expense will be recognized is approximately 1.8
years.
7. WARRANTS
The following table summarizes information
about Common Stock warrants outstanding and exercisable at January 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
$
1.00
500,000
1.1
$
1.00
500,000
$
1.00
$
1.75
161,342
1.8
$
1.75
161,342
$
1.75
$
3.00
9,427,196
2.2
$
3.00
9,427,196
$
3.00
$
6.25
61,250
3.4
$
6.25
61,250
$
6.25
$ 1.00 - $ 6.25
10,149,788
2.4
$
2.90
10,149,788
$
2.90
The estimated fair value of warrants granted during the nine
months ended January 31, 2022 were calculated using the Black-Scholes option-pricing model using the following assumptions:
Schedule of assumptions used
For the Nine Months
Ended January 31, 2022
Expected term (in years)
5.00
Volatility
86.31 %
Risk-free interest rate
0.87 % - 0.90 %
Dividend yield
0.0 %
Expected Term: The expected
term represents the period that the warrants granted are expected to be outstanding.
Expected Volatility: The Company
uses an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry
that were deemed to be representative of future stock price trends as the Company did not have sufficient trading history for its Common
Stock at January 31, 2022. The Company will continue to apply this process until a sufficient amount of historical information regarding
the volatility of its own stock price becomes available.
Risk-Free Interest Rate: The
Company based the risk-free interest rate over the expected term of the warrants based on the constant maturity rate of U.S. Treasury
securities with similar maturities as of the date of the grant.
Expected Dividend: The Company
has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected dividend yield was zero.
8. OTHER RELATED PARTY TRANSACTIONS
In March 2021, the Company entered into
a securities purchase agreement with Ault Lending, LLC (“AL”) pursuant to which the Company sold an aggregate of 6,666,667
shares of Common Stock for an aggregate of $ 10 million, or $1.50 per share, which sales were made in tranches. On March 9, 2021, AL paid
$ 4 million, less the $1.8 million in prior advances and the surrender for cancellation of a $50,000 convertible promissory note held by
Ault Alliance, Inc. (formerly, BitNile Holdings, Inc.) (“Ault Alliance”), the parent company of AL, for an aggregate of 2,666,667
shares of Common Stock. Under the terms of the securities purchase agreement, AL (i) purchased an additional 1,333,333 shares of Common
Stock upon approval of the IND for Phase IA clinical trials for AL001 for a purchase price of $2 million, and (ii) purchased 2,666,667
shares of Common Stock upon the completion of Phase IA clinical trials for AL001 for a purchase price of $4 million. The Company issued
to AL warrants to purchase 3,333,333 shares of Common Stock at an exercise price of $3.00 per share. Finally, the Company agreed that
for a period of 18 months following the date of the payment of the final tranche of $4 million, AL will have the right to invest an additional
$10 million on the same terms, except that no specific milestones have been determined with respect to the additional $10 million as of
the date of this Quarterly Report.
In November 2022, the Company entered into
a marketing and brand development agreement with Ault Alliance, effective August 1, 2022, whereby Ault Alliance 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 $1.50 per share. On November 11, 2022, the Company elected to pay the fee with 933,334 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 will amortize
the expense over twelve months beginning in August 2022. At January 31, 2023, the balance of related party prepaid expenses was $ 495,000 .
16
9. COMMITMENTS AND CONTINGENCIES
Contractual Obligations
On May 1, 2016, the Company entered into
a Standard Exclusive License Agreement for ALZN002 with Sublicensing Terms with Licensor, pursuant to which 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.
There
are certain initial license fees and milestone payments required to be paid by the Company to the Licensor pursuant to the terms of license
agreements. The license agreements for ALZN002 require the Company to pay royalty payments of 4 % on net sales of products developed
from the licensed technology for ALZN002 while the license agreements for AL001 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 ALZN002 and an initial license fee of $200,000 for AL001. As an additional licensing fee for the license of
ALZN002, the Licensor received 3,601,809 shares of common stock. As an additional licensing fee for the license of the AL001 technologies,
the Licensor received 2,227,923 shares of common stock. Minimum royalties for AL001 are $25,000 in 2023, $45,000 in 2024 and $70,000 in
2025 and every year thereafter, for the life of the agreement. Minimum royalties for ALZN002 are $20,000 in 2022, $40,000 in 2023 and
$50,000 in 2024 and every year thereafter, for the life of the respective agreement. 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 License:
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
12 months from completion of the first Phase II clinical trial
Upon first patient treated in a Phase III clinical trial
$
10,000,000
8 years from the effective date of the agreement
Upon U.S. Food and Drug Administration (“FDA”) approval
* Milestone met and completed
ALZN002 License:
Payment
Due Date
Event
$
50,000
*
Completed September 2022
Upon IND application filing
$
50,000
12 months from IND application filing date
Upon first dosing of patient in first Phase I clinical trial
$
175,000
12 months from first patient dosed in Phase I
Upon completion of first Phase I clinical trial
$
500,000
24 months from completion of first Phase I clinical trial
Upon completion of first Phase II clinical trial
$
1,000,000
12 months from completion of the first Phase II clinical trial
Upon first patient treated in a Phase III clinical trial
$
10,000,000
7 years from the effective date of the agreement
Upon FDA BLA approval
* Milestone met and completed
The
Company has met the pre-IND meeting, IND application filing, and successfully completed the Phase I clinical trial milestones encompassing
AL001 and the IND application filing milestone for ALZN002. If the Company fails to meet a milestone by its specified date, the Licensor
may terminate the license agreement.
17
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 Licensor remains the owner of any equity securities of the Company.
On
June 10, 2020, the Company obtained two (2) additional royalty-bearing exclusive worldwide licenses from the Licensor to a therapy
named AL001. One of the additional licenses is for the treatment of neurodegenerative diseases excluding Alzheimer’s and the other
license is for the treatment of psychiatric diseases and disorders. There are certain license fees and milestone payments required to
be paid pursuant to the terms of the Standard Exclusive License Agreements with Sublicensing Terms, both dated June 10, 2020 and
effective as of November 1, 2019, with the Licensor and the University of South Florida (the “June AL001 License Agreements”).
Under each of the June AL001 License Agreements, a royalty payment of 3 % is required on net sales of products developed from the
licensed technology. For the two (2) additional AL001 licenses, in the aggregate, the Company has paid initial license fees of $ 20,000 .
Additionally, under each of the June AL001 License Agreements, the Company is required to pay milestone payments on the due dates to the
Licensor for the license of the technology, as follows:
Additional AL001 Licenses:
Payment
Due Date
Event
$
50,000
Upon IND application filing
IND application filing
$
150,000
12 months from IND filing date
Upon first dosing of patient in a clinical trial
$
400,000
12 months from first patient dosing
Upon Completion of first clinical trial
$
1,000,000
36 months from completion of the first Phase II clinical trial
Upon first patient treated in a Phase III clinical trial
$
8,000,000
8 years from the effective date of the agreement
First commercial sale
10. 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
Preferred Shares. 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 Preferred Shares
As of January 31, 2023, there were no Series
A Preferred Shares or any other shares of Preferred Stock issued or outstanding.
Common Stock
On April 30, 2019, the Company and ALSF
entered into a SPA for the purchase of 10,000,000 shares of Common Stock for a total purchase price of $ 15,000,000 , or $ 1.50 per share
with 5,000,000 warrants with a 5 -year life and an exercise price of $ 3.00 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.
In March 2021, the Company entered into
a securities purchase agreement with AL pursuant to which the Company agreed to sell an aggregate of 6,666,667 shares of Common Stock
for an aggregate of $ 10 million, or $ 1.50 per share, which sales were made in tranches. On March 9, 2021, AL paid $ 4 million, less
the $ 1.8 million in prior advances and the surrender for cancellation of a $ 50,000 convertible promissory note held by Ault Alliance,
for an aggregate of 2,666,667 shares of Common Stock. Under the terms of the securities purchase agreement, AL (i) purchased an additional
1,333,333 shares of Common Stock upon approval by the FDA of the Company’s IND for its Phase IA clinical trials for AL001 for a
purchase price of $2 million, and (ii) purchased 2,666,667 shares of Common Stock upon the completion of these Phase IA clinical trials
for AL001 for a purchase price of $4 million. The Company further agreed to issue to AL warrants to purchase 3,333,333 shares of Common
Stock at an exercise price of $3.00 per share.
Finally, the Company agreed that for a period
of 18 months following the date of the payment of the final tranche of $4 million, on April 28, 2022, AL will have the right to invest
an additional $10 million on the same terms, except that no specific milestones have been determined with respect to the additional $ 10
million as of the date of this Quarterly Report.
18
11. SUBSEQUENT EVENTS
The Company has evaluated subsequent events
through the date the financial statements were issued. The Company has determined that there are no such events that warrant disclosure
or recognition in the condensed financial statements presented herein.
19
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.