UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC
20549
FORM 10-Q
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended October
31, 2025
OR
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 001-40483
ALZAMEND NEURO, INC.
(Exact name of registrant as specified in its
charter)
Delaware
81-1822909
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification Number)
3480 Peachtree Road NE , Second Floor Suite 103 , Atlanta , GA
30326
( 844 ) 722-6303
(Address of principal executive offices)
(Zip Code)
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b)
of the Act:
Title of Each Class
Trading Symbol
Name of each exchange on which registered
Common Stock, $0.0001 par value per share
ALZN
NASDAQ Capital Market
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding
12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer
¨
Accelerated filer ¨
Non-accelerated filer
x
Smaller reporting company x
Emerging growth company
x
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
As of December 9, 2025 there were 3,801,604 shares of registrant’s
common stock, $0.0001 par value per share, outstanding.
Table of Contents
Page
PART I.
FINANCIAL INFORMATION
3
Item 1.
Financial Statements (unaudited)
3
Condensed Balance Sheets
3
Condensed Statements of Operations
4
Condensed Statements of Stockholders’ Equity
5
Condensed Statements of Cash Flows
9
Notes to Condensed Financial Statements
11
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
20
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
30
Item 4.
Controls and Procedures
30
PART II.
OTHER INFORMATION
31
Item 1.
Legal Proceedings
31
Item 1A.
Risk Factors
31
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
31
Item 3.
Defaults Upon Senior Securities
31
Item 4.
Mine Safety Disclosures
31
Item 5.
Other Information
31
Item 6.
Exhibits
31
Signatures
33
2
PART I – FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Alzamend Neuro, Inc.
Condensed Balance Sheets
October 31, 2025
April 30, 2025
(Unaudited)
(Audited)
ASSETS
CURRENT ASSETS
Cash
$ 4,449,433
$ 3,948,658
Prepaid expenses and other current assets
272,015
228,719
TOTAL CURRENT ASSETS
4,721,448
4,177,377
Property, plant and equipment, net
370,236
425,606
TOTAL ASSETS
$ 5,091,684
$ 4,602,983
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$ 717,488
$ 634,761
TOTAL LIABILITIES, ALL CURRENT
717,488
634,761
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY
Series B Convertible Preferred Stock; nil 0
designated and nil 0
issued and outstanding as of October 31, 2025 and 6,000 shares designated, $ 1,000
stated value per share, and 2,100
issued and outstanding as of April 30, 2025
-
-
Common stock, $ 0.0001 par value: 300,000,000 shares authorized; 3,801,604 and 778,733 issued and outstanding as of October 31,
2025 and April 30, 2025, respectively
380
78
Additional paid-in capital
66,612,519
62,503,405
Accumulated deficit
( 62,238,703 )
( 58,535,261 )
TOTAL STOCKHOLDERS’ EQUITY
4,374,196
3,968,222
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 5,091,684
$ 4,602,983
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,
2025
2024
2025
2024
OPERATING EXPENSES
Research and development
$ 176,283
$ 311,088
$ 1,917,150
$ 517,659
General and administrative
821,826
1,046,980
1,781,160
1,802,814
Total operating expenses
998,109
1,358,068
3,698,310
2,320,473
Loss from operations
( 998,109 )
( 1,358,068 )
( 3,698,310 )
( 2,320,473 )
OTHER EXPENSE, NET
Interest expense
( 2,649 )
( 3,495 )
( 5,132 )
( 15,501 )
Total other expense, net
( 2,649 )
( 3,495 )
( 5,132 )
( 15,501 )
NET LOSS
( 1,000,758 )
( 1,361,563 )
( 3,703,442 )
( 2,335,974 )
Dividends on preferred shares
-
( 53,651 )
-
( 53,651 )
NET LOSS AVAILABLE TO COMMON SHARES
$ ( 1,000,758 )
$ ( 1,415,214 )
$ ( 3,703,442 )
$ ( 2,389,625 )
Basic and diluted net loss per common share
$ ( 0.30 )
$ ( 3.61 )
$ ( 1.33 )
$ ( 9.98 )
Basic and diluted weighted average common shares outstanding
3,380,968
392,411
2,777,867
239,417
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 October 31, 2025
(Unaudited)
Series B Convertible
Additional
Preferred
Stock
Common
Stock
Paid-In
Accumulated
Shares
Amount
Shares
Amount
Capital
Deficit
Total
BALANCES, July 31, 2025 -
1,535
$ - -
3,139,861
$ 314
$ 66,581,071
$ ( 61,237,945 )
$ 5,343,440
Conversion of preferred stock to common stock
( 1,535 )
-
661,743
66
( 66 )
-
-
Stock-based compensation to employees and consultants
-
-
-
-
31,514
-
31,514
Net loss -
-
- -
-
-
-
( 1,000,758 )
( 1,000,758 )
BALANCES, October 31, 2025 -
-
$ - -
3,801,604
$ 380
$ 66,612,519
$ ( 62,238,703 )
$ 4,374,196
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 October 31, 2024
(Unaudited)
Series A Convertible
Series B Convertible
Additional
Preferred
Stock
Preferred
Stock
Common
Stock
Paid-In
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Total
BALANCES, July 31, 2024
188
$ -
2,100
$ -
95,703
$ 10
$ 53,782,490
$ ( 54,994,819 )
$ ( 1,212,319 )
Issuance of common stock for cash, net of issuance costs
-
-
-
-
83,987
8
1,174,216
-
1,174,224
Issuance of common stock for restricted stock awards
-
-
-
-
9
-
-
-
-
Issuance of preferred stock for cash, net of issuance costs
550
-
-
-
-
-
5,125,000
-
5,125,000
Conversion of preferred stock to common stock
( 650 )
-
-
-
401,550
40
( 40 )
-
-
Stock-based compensation to employees and consultants
-
-
-
-
-
-
81,277
-
81,277
Net loss
-
-
-
-
-
-
-
( 1,415,214 )
( 1,415,214 )
BALANCES, October 31, 2024
88
$ -
2,100
$ -
581,249
$ 58
$ 60,162,943
$ ( 56,410,033 )
$ 3,752,968
The accompanying notes are an integral part of
these unaudited condensed financial statements.
6
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’
Equity
For the Six Months Ended October 31, 2025
(Unaudited)
Series B Convertible
Series C Convertible
Additional
Preferred
Stock
Preferred
Stock
Common
Stock
Paid-In
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Total
BALANCES, April 30, 2025
2,100
$ -
150
$ -
778,733
$ 78
$ 62,503,405
$ ( 58,535,261 )
$ 3,968,222
Issuance of preferred stock for cash, net of issuance
costs
-
-
425
-
-
-
4,035,000
-
4,035,000
Conversion of preferred stock to common stock
( 2,100 )
-
( 575 )
-
3,022,871
302
( 302 )
-
-
Stock-based compensation to employees and consultants
-
-
-
-
-
-
74,416
-
74,416
Net loss
-
-
-
-
-
-
-
( 3,703,442 )
( 3,703,442 )
BALANCES, October 31, 2025
-
$ -
-
$ -
3,801,604
$ 380
$ 66,612,519
$ ( 62,238,703 )
$ 4,374,196
The accompanying notes are an integral part of
these unaudited condensed financial statements.
7
Alzamend Neuro, Inc.
Condensed Statements of Stockholders’
Deficit
For the Six Months Ended October 31, 2024
(Unaudited)
Series A Convertible
Series B Convertible
Additional
Preferred
Stock
Preferred
Stock
Common
Stock
Paid-In
Accumulated
Shares
Amount
Shares
Amount
Shares
Amount
Capital
Deficit
Total
BALANCES, April 30, 2024
-
$ -
2,100
$ -
76,444
$ 8
$ 51,426,215
$ ( 54,020,408 )
$ ( 2,594,185 )
Issuance of common stock for cash, net of issuance
costs
-
-
-
-
83,987
8
1,174,216
-
1,174,224
Issuance of preferred stock for cash
800
-
-
-
-
-
7,088,644
-
7,088,644
Issuance of common stock for restricted stock awards
-
-
-
-
9
-
-
-
-
Conversion of note payable and interest to preferred
stock
-
-
-
-
-
-
311,356
-
311,356
Conversion of preferred stock to common stock
( 712 )
-
-
-
420,809
42
( 42 )
-
-
Stock-based compensation to employees and consultants
-
-
-
-
-
-
162,554
-
162,554
Net loss
-
-
-
-
-
-
-
( 2,389,625 )
( 2,389,625 )
BALANCES, October 31, 2024
88
$ -
2,100
$ -
581,249
$ 58
$ 60,162,943
$ ( 56,410,033 )
$ 3,752,968
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,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 3,703,442 )
$ ( 2,389,625 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense
55,370
25,370
Interest expense - debt discount
-
9,286
Stock-based compensation to employees and consultants
74,416
162,554
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 43,296 )
( 594,475 )
Accounts payable and accrued liabilities
82,727
( 1,668,953 )
Net cash used in operating activities
( 3,534,225 )
( 4,455,843 )
Cash flows from investing activities:
Purchase of equipment
-
( 90,000 )
Net cash used in investing activities
-
( 90,000 )
Cash flows from financing activities:
Net proceeds from the issuance of common stock
-
1,174,224
Net proceeds from the issuance of preferred stock
4,035,000
7,088,644
Net cash provided by financing activities
4,035,000
8,262,868
Net increase in cash
500,775
3,717,025
Cash at beginning of period
3,948,658
376,048
Cash at end of period
$ 4,449,433
$ 4,093,073
Supplemental disclosures of cash flow information:
Non-cash financing activities:
Conversion of Series A convertible preferred stock
$ -
$ 7,120,133
Conversion of Series B convertible preferred stock
$ 2,100,000
$ -
Conversion of Series C convertible preferred stock
$ 5,757,176
$ -
Fair value of warrants issued in connection with Series A convertible preferred stock
$ -
$ 1,635,489
Conversion of note payable and accrued interest into Series B convertible preferred stock
$ -
$ 311,356
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 Licensor.
The Company devotes
substantially all its efforts towards research and development of its two product candidates and raising capital. The Company has
not generated any product revenue to date. The Company has financed its operations to date primarily through debt financings and
through the sale of its common stock, par value $ 0.0001
per share (“Common Stock”) and its preferred stock, par value $ 0.0001
per share. The Company expects to continue to incur net losses in the foreseeable future.
Reverse Stock Split
On
July 10, 2024, pursuant to the authorization provided by the Company’s stockholders at its annual 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-ten (the “First Reverse Split”). The First 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 First Reverse Split, each ten shares
of Common Stock issued and outstanding prior to the First Reverse Split were converted into one share of Common Stock. The First Reverse
Split became effective in the State of Delaware on July 16, 2024. All share amounts in these condensed financial statements have been
updated for all periods presented to reflect the First Reverse Split.
On
May 6, 2025, pursuant to the authorization provided by the Company’s stockholders at its annual 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-nine (the “Second Reverse Split”). The Second 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 Second Reverse Split, each
nine shares of Common Stock issued and outstanding prior to the Second Reverse Split were converted into one share of Common Stock. The
Second Reverse Split became effective in the State of Delaware on May 12, 2025. All share amounts in these condensed financial statements
have been updated for all periods presented to reflect the Second 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,
2025, the Company had cash of $ 4.4 million, working
capital of $ 4.0 million, an
accumulated deficit of $ 62.2
million and stockholders’ equity of $ 4.4
million. For the three and six months ended October 31, 2025, the Company had net losses of $ 1.0
million and $ 3.7 million, respectively. For the six months ended October 31, 2025, cash used in operating activities was
$ 3.5 million.
Historically, the Company has financed its operations principally through issuances of equity and debt instruments.
Management 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 during the twelve-month period subsequent to the issuance of the financial
statements included in this Quarterly Report. These factors create substantial doubt about our ability
to continue as a going concern . In order to continue as a going concern, the Company will need to raise additional funds. The Company
plans to seek additional funding through public equity, private equity and debt financings. 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 Annual Report on Form 10-K for the year ended April 30,
2025, filed with the SEC on July 22, 2025. 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, 2025 has been derived from the audited balance sheet at April 30, 2025 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, 2025
and April 30, 2025, 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.
Property and Equipment,
Net
Property and equipment are
stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful life
of five years. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred.
Research and Development
Expenses
Research and development costs
are expensed as incurred. Research and development costs consist of scientific consulting fees, clinical trial fees and lab supplies,
as well as fees paid to other entities that conduct certain research and development activities on behalf of the Company.
The Company has acquired and
may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire
license, products or rights, as well as any future milestone payments, are immediately recognized as research and development expenses,
provided that there is no alternative future use of the rights in other research and development projects.
11
Stock-Based Compensation
The Company recognizes stock-based
compensation expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they
occur. The Company’s stock-based compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes
option pricing model. To the extent any stock option grants are made subject to the achievement of a performance-based milestone, management
evaluates when the achievement of any such performance-based milestone is probable based on the relative satisfaction of the performance
conditions as of the reporting date.
The Company recognizes stock-based
compensation expense for restricted stock units on a straight-line basis over the requisite service period and account for forfeitures
as they occur. The Company’s stock-based compensation for restricted stocks is based upon the estimated fair value of the Common
Stock.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. Certain of such assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and the
Company uses significantly different assumptions or estimates, the Company’s stock-based compensation could be materially different.
Warrants
The Company accounts for stock
warrants as either equity instruments, derivative liabilities, or liabilities in accordance with FASB ASC 480, Distinguishing
Liabilities from Equity and FASB ASC 815, Derivatives and Hedging (“ASC 815”) , depending on the
specific terms of the warrant agreement.
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.
Based on the terms of the
Company’s warrant agreements, the Company accounted for the warrants as equity instruments as the warrants were indexed to the Common
Stock, required settlement in shares and would be classified as equity under ASC 815.
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 Three Months Ended October 31,
2025
2024
Stock options (1)
12,854
12,998
Restricted stock units
-
9
Warrants
137,051
97,050
149,905
110,057
(1) The Company has excluded 1,111 stock options for the six months ended October 31, 2024, with an exercise
price of $0.54, 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
Preferred Stock Classification
Management analyzes the terms
of its preferred stock using ASC Topic No. 480, Distinguishing Liabilities from Equity , to determine whether the Company’s
preferred stock should be classified as a liability or equity, and if classified as equity, permanent or temporary. Common criteria management
considers are redemption provisions, conversion options, mandatory fixed dividends, discretionary dividends based on earnings, voting
rights and collateral requirements.
Segment Reporting
In the fiscal year ended April
30, 2025, the Company adopted Accounting Standard Update No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment
Disclosures. The Company operates as a single operating and reportable segment, which reflects the manner in which the Chief Operating
Decision Maker, the Company’s Chief Executive Officer, manages the business and allocates resources. The Company is a clinical-stage
biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD, with key operational
decisions based on cash availability, development milestones, and return on investment associated with future manufacturing and commercialization
opportunities.
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.
Management has considered
all other recently issued accounting standards and does not believe the adoption of such standards will have a material impact on the
Company’s condensed financial statements.
4. 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, 2025
April 30, 2025
Prepaid clinical trial expenses
$ 92,370
$ 178,922
Prepaid insurance
159,806
42,584
Other prepaid expenses
19,839
7,213
Total prepaid expenses and other current assets
$ 272,015
$ 228,719
Prepaid clinical trial expenses
at October 31, 2025, represented the unamortized portion of prepaid clinical trial expense and will be amortized as used over the next
six months.
On June 14, 2025, the Company
purchased directors’ and officers’ insurance for 12 months in the amount of $ 220,000 . Prepaid insurance at October 31, 2025
represented the unamortized portion of directors’ and officers’ insurance.
5. 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 9,259 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 5,556 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 7,407 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.
Restricted Stock. In
May 2021, the Company issued restricted stock awards pursuant to the 2021 Plan to one employee and four independent Board members. The
restricted stock award vests over 48 months. The award requires continued service to the Company during the vesting period. The vesting
provisions of individual awards may vary as approved by the Board. Compensation expense for restricted stock is generally recorded based
on its market value on the date of grant and recognized ratably over the associated service and performance period.
Stock Options. 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 calculated using the simplified method. 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, 2025 is presented below:
Schedule of stock 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, 2025
6,889
9,406
$ 1,802.18
4.80
$ -
Options granted
-
-
$ -
-
Options exercised
-
-
$ -
-
Options expired
-
-
$ -
-
Balance at October 31, 2025
6,889
9,406
$ 1,802.18
4.30
$ -
Options vested and expected to vest at October 31, 2025
9,406
$ 1,802.18
4.30
$ -
Options exercisable at October 31, 2025
8,642
$ 1,820.61
4.05
$ -
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.
Performance Contingent
Stock Options Granted to Employee
On November 26, 2019, the
Board granted 3,148 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 $2,025.00 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 ranged from $13,500 per share to $54,000 per share. In the event
any of the stock price milestones are not achieved within three years, the unvested portion of the performance options will be reduced
by 25%.
On November 22, 2022, the
Compensation Committee of the Board modified the performance criteria for these awards. The target price range is now $13,500 per share
to $27,000 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 October 31, 2025, the Company’s management 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 1,481 performance-based stock options to the Chief Executive Officer at an exercise price
of $1,579.50 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. During the year ended April 30, 2023, the
Company management 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, 2025, the Company’s management 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.
14
Stock-Based Compensation
Expense
The Company’s results
of operations, which included expenses relating to stock-based compensation for three and six months ended October 31, 2025 and 2024,
were comprised as follows:
Schedule of stock-based compensation
For the Three Months Ended October 31,
For the Six Months Ended October 31,
2025
2024
2025
2024
General and administrative
$ 31,514
$ 81,277
$ 74,416
$ 162,554
As of October 31, 2025, total
unamortized stock-based compensation expense related to unvested employee and non-employee awards that were expected to vest was $ 16,000 .
The weighted-average period over which such stock-based compensation expense will be recognized was approximately 0.1 years.
6. WARRANTS
Warrant activity for the
six months ended October 31, 2025 is presented below:
Schedule of warrant activity
Number
Outstanding
Weighted Average
Exercise Price
Outstanding at April 30, 2025
137,051
$ 103.56
Cancelled/Expired
( 80 )
$ 4,050.00
Outstanding at October 31, 2025
136,971
$ 101.26
The following table summarizes
information about Common Stock warrants outstanding and exercisable at October 31, 2025:
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
$ 8.29
111,111
4.3
$ 8.29
111,111
$ 8.29
$ 108.00
23,334
3.8
$ 108.00
23,334
$ 108.00
$ 4,050.00
2,481
0.9
$ 4,050.00
2,481
$ 4,050.00
$ 8,437.50
45
0.6
$ 8,437.50
45
$ 8,437.50
$ 8.29 - $ 8,437.50
136,971
4.2
$ 103.56
136,971
$ 103.56
7. 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.
15
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 1,650 shares of Common Stock. Minimum royalties for
AL001 License Agreements are $ 40,000 on the first anniversary of the first commercial sale, $ 80,000 on the second anniversary
of the first commercial sale and $ 100,000 on the third anniversary of the first commercial sale and every year thereafter, for the
life of the AL001 License Agreements.
On
May 1, 2016, the Company entered into a Standard Exclusive License Agreement with Sublicensing Terms for ALZN002 with the Licensor (the
“ALZN002 License”), pursuant to which the Licensor granted the Company a royalty bearing exclusive worldwide license limited
to the field of Alzheimer’s Immunotherapy and Diagnostics, under United States Patent No. 8,188,046, entitled “Amyloid Beta
Peptides and Methods of Use”, filed April 7, 2009 and granted May 29, 2012. On August 18, 2017, the Company entered into the First
Amendment to the ALZN002 License, on May 7, 2018, the Company entered into the Second Amendment to the ALZN002 License, on January 31,
2019, the Company entered into the Third Amendment to the ALZN002 License, on January 24, 2020, the Company entered into the Fourth Amendment
to the ALZN002 License, on March 30, 2021, the Company entered into the Fifth Amendment to the ALZN002 License, on April 17, 2023, the
Company entered into the Sixth Amendment to the ALZN002 License and on December 11, 2023, the Company entered into the Seventh Amendment
to the ALZN002 License (collectively, the “ALZN002 License Agreement”). The Seventh Amendment to the ALZN002 License modified
the timing of the payments for the license fees.
The
ALZN002 License Agreement requires the Company to pay royalty payments of 4 % on net sales of products developed from the licensed
technology for ALZN002. The Company has already paid an initial license fee of $ 200,000 for ALZN002. As an additional licensing
fee for the license of ALZN002, the Licensor received 2,668 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
$
50,000 *
Pre-IND Meeting - Completed September 2019
$
65,000 *
IND application filing - Completed June 2021
$
190,000 *
Upon first dosing of patient in a clinical trial - Completed December 2021
$
500,000 *
Upon completion of first clinical trial - Completed March 2022
$
1,250,000
Upon first patient treated in a Phase III clinical trial
$
10,000,000
Upon FDA NDA approval
* Milestone met and completed
16
ALZN002 License:
Payment
Due Date
$
50,000 *
Upon IND application - Completed January 2022
$
50,000
Upon first dosing of patient in first Phase I clinical trial
$
500,000
Upon completion of first Phase IIB clinical trial
$
1,000,000
Upon first patient treated in a Phase III clinical trial
$
10,000,000
Upon first commercial sale
* Milestone met and completed
Additional AL001 Licenses:
Payment
Due Date
$
2,000,000
Upon first patient treated in a Phase III clinical trial
$
16,000,000
First commercial sale
8. EQUITY TRANSACTIONS
The
Company is authorized to issue 10,000,000 shares of Preferred Stock, $ 0.0001 par value. As of October 31, 2025, the rights, preferences,
privileges and restrictions 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.
On
July 9, 2025, the Company filed a Certificate of Elimination to eliminate the Company’s Series A Convertible Preferred Stock. The
shares that were designated as Series A Convertible Preferred Stock were returned to the status of authorized but unissued.
On
October 14, 2025, the Company filed a Certificate of Elimination to eliminate the Company’s Series B Convertible Preferred Stock.
The shares that were designated as Series B Convertible Preferred Stock were returned to the status of authorized but unissued.
On
October 14, 2025, the Company filed a Certificate of Elimination to eliminate the Company’s Series C Convertible Preferred Stock.
The shares that were designated as Series C Convertible Preferred Stock were returned to the status of authorized but unissued.
Series B Convertible
Preferred Stock
On January 31, 2024, the Company
and Ault Lending, LLC (“Ault Lending”), a related party due to common management, entered into a securities purchase agreement
(the “AL SPA”) for the purchase of up to 6,000 shares of Series B Convertible Preferred Stock and warrants to purchase shares
up to 66,667 shares of Common Stock. The AL SPA provided that Ault Lending could have purchased up to $6 million of Series B Convertible
Preferred Stock in one or more closings. Ault Lending had the right to purchase up to $2 million of Series B Convertible Preferred Stock,
on or before March 31, 2024, and the right to purchase up to $4 million of Series B Convertible Preferred Stock after March 31, 2024,
but on or before March 31, 2025 (the “Termination Date”). The final closing did not occur prior to the Termination Date and
the AL SPA automatically terminated.
On January 31, 2024, the Company
sold 1,220 shares of Series B Convertible Preferred Stock and warrants to purchase 13,556 shares of Common Stock with an exercise price
of $ 108.00 , for a total purchase price of $ 1.22 million. The purchase price was paid by the cancellation of $ 1.15 million of cash advances
made by Ault Lending to the Company between November 9, 2023 and January 31, 2024 and a subscription receivable of $ 70,000 .
On March 26, 2024, the Company
sold 780 shares of Series B Convertible Preferred Stock and warrants to purchase 8,667 shares of Common Stock with an exercise price of
$ 108.00 , for a total purchase price of $ 780,000 .
On April 29, 2024, the Company
sold 100 shares of Series B Convertible Preferred Stock and warrants to purchase 1,111 shares of Common Stock with an exercise price of
$ 108.00 , for a total purchase price of $ 100,000 .
17
The Series B Convertible Preferred
Stock has a stated value of $1,000 per share (“Stated Value”) and does not accrue dividends. Each share of Series B Convertible
Preferred Stock is convertible into a number of shares of Common Stock determined by dividing the Stated Value by $90.00 (the “Conversion
Price”). The Conversion Price is subject to adjustment in the event of an issuance of Common Stock at a price per share lower than
the Conversion Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The holders
of the Series B Convertible Preferred Stock are entitled to vote with the Common Stock as a single class on an as-converted basis, subject
to applicable law provisions of the Delaware General Company Law and Nasdaq, provided however, that for purposes of complying with Nasdaq
regulations, the conversion price, for purposes of determining the number of votes the holder of Series B Convertible Preferred Stock
is entitled to cast, shall not be lower than $78.57 (the “Voting Floor Price”), which represents the closing sale price of
the Common Stock on the trading day immediately prior to the Execution Date. The Voting Floor Price shall be adjusted for stock dividends,
stock splits, stock combinations and other similar transactions. Upon a liquidation event the holders of Series B Convertible Preferred
Stock receive a liquidation preference ahead of common stockholders.
The warrants have an exercise
price of $108.00 (the “Exercise Price”) and became exercisable on the first business day after the six-month anniversary of
issuance (the “Initial Exercise Date”) and have a five-year term, expiring on the fifth anniversary of the Initial Exercise
Date. The Exercise Price is subject to adjustment in the event of an issuance of Common Stock at a price per share lower than the Exercise
Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events.
During the six months ended
October 31, 2025, Ault Lending converted 2,100 shares of Series B Convertible Preferred Stock into 905,172 shares of Common Stock.
Series
C Convertible Preferred Stock
On
February 28, 2025, the Company and Orchid Finance, LLC (“Orchid”) entered into the Securities Purchase and Exchange
Agreement (the “Orchid SPEA”) for the purchase of up to 500 shares of Series C Convertible Preferred Stock in several tranche
closings and warrants to purchase shares up to 111,111 shares of Common Stock with an exercise price of $ 8.29 (the “ Series
C Exercise Price”) and are exercisable upon issuance and have a five-year term, expiring on the fifth anniversary of issuance.
The Series C Exercise Price is subject to adjustment in the event of an issuance of Common
Stock at a price per share lower than the Series C Exercise Price then in effect, as well
as upon customary stock splits, stock dividends, combinations or similar events. In addition, 97.7511 shares of Series A Convertible Preferred
Stock were exchanged for 97.7511 shares of Series C Convertible Preferred Stock. The fair market value of the warrants on the date of
issuance was $ 577,073 .
Between April 28, 2025, and
June 13, 2025, the Company sold 500 shares of Series C Convertible Preferred Stock for a total purchase price of $ 5.0 million. Effective
June 13, 2025, the Orchid SPEA was terminated as all the shares of Series C Convertible Preferred Stock were sold.
The
registration statement registering for resale the shares of Common Stock issuable upon conversion of the Series C Convertible Preferred
Stock and exercise of the warrants was declared effective on April 8, 2025. In addition, the Company agreed to use its best efforts to
hold a meeting of its stockholders within 90 days of the execution date of the Orchid SPEA for purposes of seeking stockholder approval
of the issuance of all the shares of Common Stock issuable upon conversion of the Series C Convertible Preferred Stock and the exercise
of the warrants in excess of the “Nasdaq Limit,” which is 19.99% of the shares of Common Stock issued and outstanding on the
execution date of the Orchid SPEA. The Company held its annual meeting of stockholders on April 25, 2025, at which time, the stockholders
approved the issuance of all the shares of Common Stock issuable upon conversion of the Series C Convertible Preferred Stock and the exercise
of the warrants in excess of the Nasdaq Limit.
The
Series C Convertible Preferred Stock has a stated value of $10,000 per share (“Series
C Stated Value”) and accrued dividends at the rate of 15% per annum, payable quarterly in arrears in cash or paid-in-kind
shares, in Orchid’s sole discretion. Each share of Series C Convertible Preferred Stock is convertible into a number of shares of
Common Stock determined by dividing the Series C Stated Value by (y)
the greater of (i) $0.90 per share (“Series C Floor Price”) and (ii) the lesser of (A) $135.00 and (B) 80% of the lowest closing
price of our Common Stock during the three trading days immediately prior to the date of conversion into conversion shares (the “ Series
C Conversion Price”). The Series C Conversion Price was subject to adjustment
in the event of an issuance of Common Stock at a price per share lower than the Series C Conversion
Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The holders of the Series
C Convertible Preferred Stock were entitled to vote with the Common Stock as a single class on an as-converted basis, subject to applicable
law provisions of the Delaware General Corporation Law and Nasdaq, provided however, that for purposes of complying with Nasdaq regulations,
the conversion price, for purposes of determining the number of votes the holder of Series C Convertible Preferred Stock is entitled to
cast, shall not be lower than $7.5375 (the “Series C Voting Floor Price”), which represents the closing sale price of the
Common Stock on the trading day immediately prior to the date of execution of the Orchid SPEA. The Series C Voting Floor Price shall be
adjusted for stock dividends, stock splits, stock combinations and other similar transactions.
During the six months ended
October 31, 2025, Orchid converted 575.7176 shares of Series C Convertible Preferred Stock into 2,117,699 shares of Common Stock.
18
9. SUBSEQUENT EVENTS
2025 Stock Incentive Plan and Option Grants
On November 13, 2025, the
Company’s Board of Directors approved and adopted the Company’s 2025 Stock Incentive Plan (“2025 Plan”). The 2025
Plan provides for the issuance of a maximum of 1.6 million shares of Common Stock to be offered 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. The 2025 Plan is subject to stockholders’ approval and will be submitted to stockholders at a meeting
of stockholders for their approval and adoption.
On November 13, 2025, the
Board also approved grants of 1.59 million options to purchase shares of Common Stock at an exercise price of $ 2.32 , which includes grants
of 1.21 million options to directors and executive officers, subject to the approval of the 2025 Plan by stockholders. Vesting for all
1.59 million grants is 50% upon stockholder approval and 50% in equal monthly installments thereafter over the next 24 months.
19
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following
management’s discussion and analysis of financial condition and results of operations in conjunction with our unaudited condensed
financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial
statements and related notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included
in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or the SEC, on July 22, 2025.
NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form
10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities
Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). This section should
be read in conjunction with our unaudited condensed financial statements and related notes included in Part I, Item 1 of this report.
The statements contained in this report that are not purely historical are forward-looking statements within the meaning of Section 27A
of the Securities Act and Section 21E of the Exchange Act.
These statements relate to
future events or our future financial performance. We have attempted to identify forward-looking statements by terminology including “anticipates,”
“believes,” “expects,” “can,” “continue,” “could,” “estimates,”
“expects,” “intends,” “may,” “plans,” “potential,” “predict,”
“should” or “will” or the negative of these terms or other comparable terminology. These statements are only predictions;
uncertainties and other factors may cause our actual results, levels of activity, performance or achievements to be materially different
from any future results, levels or activity, performance or achievements expressed or implied by these forward-looking statements. Although
we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels
of activity, performance or achievements.
In this Quarterly Report,
unless the context requires otherwise, references to the “Company,” “Alzamend,” “we,” “our company”
and “us” refer to Alzamend Neuro, Inc., a Delaware corporation.
Overview
We
were incorporated on February 26, 2016, as Alzamend Neuro, Inc. under the laws of the State of Delaware. We were formed to acquire and
commercialize patented intellectual property and know-how to prevent, treat and potentially cure the crippling and deadly Alzheimer’s
disease (“Alzheimer’s”). With our two product candidates, we aim to bring treatment or cures not only for Alzheimer’s,
but also bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”).
Existing Alzheimer’s treatments only temporarily relieve symptoms but do not, to our knowledge, slow or halt the underlying progression
of the disease. We have developed a novel approach to combat Alzheimer’s through immunotherapy.
Critical Accounting Policies and Estimates
Stock-Based Compensation. We
maintain a stock-based compensation plan as a long-term incentive for employees, non-employee directors and consultants. The plan allows
for the issuance of incentive stock options, non-qualified stock options, restricted stock units, and other forms of equity awards.
We recognize stock-based compensation
expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they occur. Our stock-based
compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes option pricing model. To the
extent any stock option grants are made subject to the achievement of a performance-based milestone, management evaluates when the achievement
of any such performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting
date.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. These assumptions include:
· Risk-Free Interest Rate. The risk-free interest rate is based on the U.S. Treasury
zero coupon issues in effect at the time of grant for periods corresponding with the expected term of the option.
· Expected Volatility. Because we do not have a sufficient trading history for our common
stock (“Common Stock”), the expected volatility was estimated based on the average volatility for comparable publicly traded
life sciences companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based
on the similar size, stage in life cycle or area of specialty. We will continue to apply this process until a sufficient amount of historical
information regarding the volatility of our own stock price becomes available.
20
· Expected Term. The expected term represents the period that the stock-based awards
are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the
end of the contractual term), as we do not have sufficient historical data to use any other method to estimate expected term.
· Expected Dividend Yield. We have never paid dividends on our Common Stock and have
no plans to pay dividends on our Common Stock. Therefore, we used an expected dividend yield of zero.
Certain of these assumptions
involve inherent uncertainties and the application of significant judgment. As a result, if factors or expected outcomes change and we
use significantly different assumptions or estimates, our stock-based compensation could be materially different.
Preferred Stock Classification.
We analyze the terms of our preferred stock using Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities
from Equity , to determine whether our preferred stock should be classified as a liability or equity, and if classified as equity,
permanent or temporary. Common criteria we consider are redemption provisions, conversion options, cumulative of mandatory fixed dividends,
discretionary dividends based on earnings, voting rights and collateral requirements.
Plan of Operations
We
intend to develop and commercialize therapeutics and vaccines that are better than existing treatments and have the potential to significantly
improve the lives of individuals afflicted by Alzheimer’s, BD, MDD and PTSD. To achieve these goals, we are pursuing the following
key business strategies:
· Advance clinical development of AL001 for Alzheimer’s, BD, MDD and PTSD treatment;
· Advance clinical development of ALZN002 for Alzheimer’s treatment;
· Expand our pipeline of pharmaceuticals to include additional indications for AL001 and delivery methods;
· Focus on translational and functional endpoints to efficiently develop product candidates; and
· Optimize the value of AL001 and ALZN002 in major markets.
Our
pipeline consists of two novel therapeutic drug candidates:
· AL001 - A patented ionic cocrystal technology delivering a therapeutic combination of lithium, salicylate
and proline through three royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and
· ALZN002 - A patented method using a mutant peptide sensitized cell as a cell-based therapeutic vaccine
that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s through a royalty-bearing exclusive
worldwide license from the Licensor.
Our
most advanced product candidate (lead product) licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium
for the treatment of Alzheimer’s, BD, MDD and PTSD. Based on our preclinical data involving mice models, AL001 treatment prevented
cognitive deficits, depression and irritability and is superior in improving associative learning and memory and irritability compared
with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s, BD, MDD
and PTSD in humans. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized,
potentially mitigating the regulatory burden for safety data.
On
May 5, 2022, we initiated a multiple-dose, steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic clinical trial
of AL001 in patients with mild to moderate Alzheimer’s and healthy subjects. We completed the Phase IIA clinical trial in March
2023 and announced positive topline data in June 2023, followed by the full data set in October 2024.
We
announced that we successfully identified a maximum tolerated dose (“MTD”) for development of AL001 from a multiple-ascending
dose study as assessed by an independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose
of 240 mg 3-times daily (“TID”), is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”).
Also, this MTD is risk-mitigated for the purpose of treating fragile populations, such as Alzheimer’s patients.
21
Lithium is a commonly prescribed
drug for manic episodes in BD type 1 as well as maintenance therapy of BD in patients with a history of manic episodes. Lithium is also
prescribed off-label for MDD, BD and treatment of PTSD, among other disorders. Lithium was the first mood stabilizer approved by the U.S.
Food and Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”)
but is underutilized perhaps because of the need for TDM. Lithium was the first drug that required TDM by regulatory authorities in product
labelling because the effective and safe range of therapeutic drug blood concentrations is narrow and well defined for treatment of BD
when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness. Existing lithium drugs suffer
from chronic toxicity, poor physicochemical properties, and poor brain bioavailability. Alzamend’s novel AL001 formulation, a lithium-salicylate/L-proline
engineered ionic cocrystal, is designed to overcome the toxicities associated with conventional lithium salts, promising a next-generation
lithium treatment with an enhanced safety profile and advantageous distribution to brain and brain structures.
Based on the results from our Phase IIA MAD study, we plan to initiate
five clinical trials to determine relative increased lithium levels in the brain compared to a marketed lithium salt for healthy subject
and patients diagnosed with mild to moderate Alzheimer’s, BD, MDD and PTSD, based on published mouse studies that predict that lithium
can be given at lower doses for equivalent therapeutic benefit when treating with AL001. For example, the goal is to replace the amount
of lithium needed for maintenance treatment of BD with a clinically relevant, lower AL001 lithium carbonate equivalent lithium dose. Such
lithium dose mitigation could redefine the landscape of neuropsychiatric, neurodegenerative, and neurological treatment practices. In
August 2024, we announced that we had partnered with Massachusetts General Hospital to serve as the contract research organization (“CRO”)
for these clinical trials.
On
November 19, 2024, we announced a final full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001
and lithium carbonate in Alzheimer’s transgenic mice. The study was conducted at the University of South Florida and the bioanalytical
procedures for determination of lithium concentration in the brain and plasma samples were conducted under good laboratory practice standards
by Sannova Analytical LLC. The study involved administering AL001, a good manufacturing practices-quality active pharmaceutical ingredient
(“API”) to 5XFAD mice, a recognized model for Alzheimer’s research, to compare its effects against lithium carbonate,
an FDA approved and marketed API. Mice received either high or low doses scaled to humans of both AL001 and lithium carbonate over a 14-day
period to observe pharmacokinetic steady-state drug conditions. On the 15th day, the mice were analyzed to assess how the treatments affected
lithium concentrations in different brain regions and in their plasma.
Based on the study, both treatments
had no negative impact on the mice's body weight or clinical signs during the treatment period. AL001 showed lower plasma lithium levels
than lithium carbonate, reducing the risk of adverse systemic effects, suggesting an expansion for safety of lithium’s therapeutic
index. Further, AL001 showed consistently higher lithium concentrations in brain tissues, particularly at lower doses, compared to lithium
carbonate. Finally, the study found that different brain regions absorb and retain lithium differently. This means treatments can potentially
be tailored to target specific brain areas, allowing for more precise treatment of various brain-related conditions when applied in human
studies.
These
results highlight the potential clinical advantages of AL001 for conditions like Alzheimer’s, BD, MDD and PTSD at low doses. By
reducing the systemic burden, AL001 could lessen the risk of side effects such as thyroid and kidney complications often associated with
extant lithium therapies. This positions AL001 as a promising candidate for safer long-term treatment options, without the need for TDM.
This innovation is specifically designed to address the needs of fragile populations, such as elderly and Alzheimer’s patients,
by offering a potentially more efficient and safer alternative to existing treatments.
The dosing level identified
as optimal in this robust nonclinical study will serve as the foundation for advancing the evaluation of AL001 in the comprehensive ‘Lithium
in Brain’ Phase II clinical trials. These trials, conducted in collaboration with Massachusetts General Hospital, will encompass
a diverse cohort of both healthy subjects and patients diagnosed with mild to moderate Alzheimer’s disease, BD, MDD and PTSD. In
May 2025, we began the trial and dosed the first healthy subject. In November 2025, we announced that we completed the clinical portion
of the Phase II study in healthy human subjects and expect to report topline data
in the first quarter of 2026.
On
September 28, 2022, we submitted an IND application to the FDA for ALZN002 and received a “study may proceed” letter on October
31, 2022. The product candidate is an immunotherapy vaccine designed to treat mild to moderate dementia of the Alzheimer’s type.
ALZN002 is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system.
It consists of autologous DCs that are activated white blood cells taken from each individual patient so that they can be engineered outside
of the body to attack Alzheimer’s-related amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed
to bolster the ability of the patient’s immune system to combat Alzheimer’s, with the goal being to foster tolerance to treatment
for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced
Alzheimer’s signs and symptoms. Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal
antibodies), active immunization with ALZN002 is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid.
This could provide a safer approach due to its reliance on autologous immune components, using each individual patient’s own white
blood cells rather than foreign cells and/or blood products.
On April 3, 2023, we announced the initiation of a Phase I/IIA clinical
trial for ALZN002 to treat mild to moderate dementia of the Alzheimer’s type. The purpose of this trial is to assess the safety,
tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of a placebo in 20-30 subjects with mild to moderate
morbidity. The primary goal of this clinical trial is to determine an appropriate dose of ALZN002 for treatment of patients with Alzheimer’s
in a larger Phase IIB efficacy and safety clinical trial. On February 13, 2024, we received notice from the company we engaged as CRO,
Biorasi, LLC (“Biorasi”) that Biorasi was terminating our contract with them. We are currently pursuing the engagement of
a replacement CRO.
22
The
continuation of our current plan of operations with respect to initiating and conducting the series of human clinical trials for each
of our therapeutics requires us to raise additional capital to fund our operations.
Because
our working capital requirements depend upon numerous factors, including the progress of our preclinical and clinical testing, timing
and cost of obtaining regulatory approvals, changes in levels of resources that we devote to the development of manufacturing and marketing
capabilities, competitive and technological advances, status of competitors, and our ability to establish collaborative arrangements with
other organizations, we will require additional financing to fund future operations.
Results of Operations
Results of Operations for the Three Months Ended October 31,
2025 and 2024
The following table summarizes
the results of our operations for the three months ended October 31, 2025 and 2024:
For the Three Months Ended October 31,
2025
2024
$ Change
% Change
OPERATING EXPENSES
Research and development
$ 176,283
$ 311,088
$ (134,805 )
-43 %
General and administrative
821,826
1,046,980
(225,154 )
-22 %
Total operating expenses
998,109
1,358,068
(359,959 )
-27 %
Loss from operations
(998,109 )
(1,358,068 )
359,959
-27 %
OTHER INCOME (EXPENSE), NET
Interest expense
(2,649 )
(3,495 )
846
-24 %
Total other expense, net
(2,649 )
(3,495 )
846
-24 %
NET LOSS
(1,000,758 )
(1,361,563 )
360,805
-26 %
Dividends on preferred shares
-
(53,651 )
53,651
*
NET LOSS AVAILABLE TO COMMON SHARES
(1,000,758 )
(1,415,214 )
414,456
29 %
Basic and diluted net loss per common share
$ (0.30 )
$ (3.61 )
$ 3.31
*
Basic and diluted weighted average common shares outstanding
3,380,968
392,411
*
* Not meaningful
Revenue
We
currently have only two product candidates, AL001 and ALZN002. These products are in the clinical stage of development and will require
extensive clinical study, review and evaluation, regulatory review and approval, significant marketing efforts and substantial investment
before either or both of them, and any respective successors, will provide us with any revenue. We did not generate any revenues
during the three months ended October 31, 2025 and 2024, and we do not anticipate that we will generate revenue for the foreseeable future.
Research and Development Expenses
Research and development expenses
for the three months ended October 31, 2025 and 2024 were $176,000 and $311,000, respectively. As reflected in the table below, research
and development expenses primarily consisted of professional fees and clinical trial fees:
For the Three Months Ended October 31,
2025
2024
$ Change
% Change
Professional fees
$ 131,041
$ 181,233
$ (50,192 )
-28 %
Clinical trial fees
39,342
124,123
(84,781 )
-68 %
Other research and development expenses
5,900
5,732
168
3 %
Total research and development expenses
$ 176,283
$ 311,088
$ (134,805 )
-43 %
* Not meaningful
23
Professional Fees
During the three months ended
October 31, 2025 and 2024, we incurred professional fees of $131,000 and $181,000, respectively, which were primarily comprised of professional
fees attributed to various types of scientific services, including FDA consulting services. The decrease relates to lower professional
fees required to support the previous and upcoming clinical trial activities.
Clinical Trial Fees
During the three months ended
October 31, 2025 and 2024, we incurred clinical trial fees of $39,000 and $124,000, respectively. The decrease in clinical trial fees
relates to the timing of our Phase IIA brain imaging study with Massachusetts General Hospital.
Other Research and Development Expenses
During the three months ended
October 31, 2025 and 2024, we incurred other fees of $6,000, which were primarily comprised of scientific materials required for our clinical
trials.
General and Administrative Expenses
General and administrative
expenses for the three months ended October 31, 2025 and 2024 were $822,000 and $1.0 million, respectively. As reflected in the table
below, general and administrative expenses primarily consisted of the following expense categories: salaries and benefits; professional
fees; insurance; stock-based compensation expense; marketing fees; and board of director fees. For the three months ended October 31,
2025 and 2024, the remaining general and administrative expenses of $85,000 and $83,000, respectively, primarily consisted of payments
for filing fees, transfer agent fees, travel and entertainment and other office expenses, none of which was significant individually.
For the Three Months Ended October 31,
2025
2024
$ Change
% Change
Salary and benefits
$ 223,782
$ 325,764
$ (101,982 )
-31 %
Professional fees
379,035
148,669
230,366
155 %
Insurance
58,737
60,239
(1,502 )
-2 %
Stock-based compensation expense
31,514
81,277
(49,763 )
-61 %
Marketing fees
-
304,000
(304,000 )
-100 %
Board of director fees
43,750
43,750
-
0 %
Other general and administrative expenses
85,008
83,281
1,727
2 %
Total general and administrative expenses
$ 821,826
$ 1,046,980
$ (225,154 )
-22 %
Salaries and Benefits
During the three months ended
October 31, 2025 and 2024, we incurred salaries and benefits of $224,000 and $326,000, respectively. The decrease in salaries and benefits
was due mainly to lower bonuses. As of October 31, 2025, we had four full-time and three part-time employees.
Professional Fees
During the three months ended
October 31, 2025 and 2024, we incurred professional fees of $379,000 and $149,000, respectively. During the three months ended October
31, 2025, we incurred $340,000 in legal fees, $24,000 in audit fees, $20,000 in tax preparation fees and $5,000 in consulting fees, offset
by $10,000 in investor relation fees due to a refund. During the three months ended October 31, 2024, we incurred $96,000 in audit fees,
$35,000 in legal fees, $14,000 in tax preparation fees and $2,000 in consulting fees. The increase in professional fees was due mainly
to higher legal and tax preparation fees, partially offset by lower audit and investor relations fees. The increase in legal fees, which
accounted for a significant proportion of the increase, was a result of actions by the CRO from the termination of our ALZN002 clinical
trial.
24
Insurance Expense
During the three months ended
October 31, 2025 and 2024, we incurred insurance expense of $59,000 and $60,000, respectively, which was primarily directors’ and
officers’ insurance.
Stock-Based Compensation Expense
During the three months ended
October 31, 2025 and 2024, we incurred general and administrative stock-based compensation expense of $32,000 and $81,000, respectively,
related to stock option grants and restricted stock grants to executives, employees and consultants. The decrease in stock-based compensation
expense for the three months ended October 31, 2025, was a result of fewer stock options vesting during the period compared to the prior
year period.
Marketing Fees
During the three months ended October 31, 2024, we incurred marketing
fees of $304,000, related to the marketing and branding of our company. We did not incur any marketing fees for the three months ended
October 31, 2025.
Results of Operations for the Six Months Ended October 31,
2025 and 2024
The following table summarizes
the results of our operations for the six months ended October 31, 2025 and 2024:
For the Six Months Ended October 31,
2025
2024
$ Change
% Change
OPERATING EXPENSES
Research and development
$ 1,917,150
$ 517,659
$ 1,399,491
270 %
General and administrative
1,781,160
1,802,814
(21,654 )
-1 %
Total operating expenses
3,698,310
2,320,473
1,377,837
59 %
Loss from operations
(3,698,310 )
(2,320,473 )
(1,377,837 )
59 %
OTHER EXPENSE, NET
Interest expense
(5,132 )
(15,501 )
10,369
-67 %
Total other expense, net
(5,132 )
(15,501 )
10,369
-67 %
NET LOSS
(3,703,442 )
(2,335,974 )
(1,367,468 )
59 %
Dividends on preferred shares
-
(53,651 )
53,651
*
NET LOSS AVAILABLE TO COMMON SHARES
(3,703,442 )
(2,389,625 )
(1,313,817 )
55 %
Basic and diluted net loss per common share
$ (1.33 )
$ (9.98 )
$ 8.65
*
Basic and diluted weighted average common shares outstanding
2,777,867
239,417
*
* Not meaningful
Revenue
We
currently have only two product candidates, AL001 and ALZN002. These products are in the clinical stage of development and will require
extensive clinical study, review and evaluation, regulatory review and approval, significant marketing efforts and substantial investment
before either or both of them, and any respective successors, will provide us with any revenue. We did not generate any revenues
during the six months ended October 31, 2025 and 2024, and we do not anticipate that we will generate revenue for the foreseeable future.
25
Research and Development Expenses
Research and development expenses
for the six months ended October 31, 2025 and 2024 were $1.9 million and $518,000, respectively. As reflected in the table below, research
and development expenses primarily consisted of professional fees and clinical trial fees:
For the Six Months Ended October 31,
2025
2024
$ Change
% Change
Professional fees
$ 204,850
$ 365,398
$ (160,548 )
-44 %
Clinical trials
1,700,726
124,123
1,576,603
1,270 %
Other research and development expenses
11,574
28,138
(16,564 )
-59 %
Total research and development expenses
$ 1,917,150
$ 517,659
$ 1,399,491
270 %
Professional Fees
During the six months ended
October 31, 2025 and 2024, we incurred professional fees of $205,000 and $365,000, respectively, which were primarily comprised of professional
fees attributed to various types of scientific services, including FDA consulting services. The decrease relates to lower professional
fees required to support the previous and upcoming clinical trial activities.
Clinical Trial Fees
During the six months ended
October 31, 2025 and 2024, we incurred clinical trial fees of $1.7 million and $124,000, respectively. The increase in clinical trial
fees relates to the timing of our Phase IIA brain imaging study with Massachusetts General Hospital.
Other Research and Development Expenses
During the six months ended
October 31, 2025 and 2024, we incurred other fees of $12,000 and $28,000, respectively, which were primarily comprised of scientific materials
required for our clinical trials.
General and Administrative Expenses
General and administrative
expenses for the six months ended October 31, 2025 and 2024 were $1.8 million. As reflected in the table below, general and administrative
expenses primarily consisted of the following expense categories: salaries and benefits; professional fees; insurance; stock-based compensation
expense; marketing fees; and board of director fees. For the six months ended October 31, 2025 and 2024, the remaining general and administrative
expenses of $187,000 and $145,000, respectively, primarily consisted of payments for filing fees, transfer agent fees, travel and entertainment
and other office expenses, none of which was significant individually.
For the Six Months Ended October 31,
2025
2024
$ Change
% Change
Salaries and benefits
$ 451,712
$ 553,559
$ (101,847 )
-18 %
Professional fees
712,426
371,096
341,330
92 %
Insurance
118,445
138,634
(20,189 )
-15 %
Stock-based compensation expense
74,416
162,554
(88,138 )
-54 %
Marketing fees
150,000
344,000
(194,000 )
-56 %
Board of director fees
87,500
87,500
-
0 %
Other general and administrative expenses
186,661
145,471
41,190
28 %
Total general and administrative expenses
$ 1,781,160
$ 1,802,814
$ (21,654 )
-1 %
Salaries and Benefits
During the six months ended
October 31, 2025 and 2024, we incurred salaries and benefits of $452,000 and $554,000, respectively. The decrease in salaries and benefits
was due mainly to lower bonuses. As of October 31, 2025, we had four full-time and three part-time employees.
Professional Fees
During the six months ended
October 31, 2025 and 2024, we incurred professional fees of $712,000 and $371,000, respectively. During the six months ended October 31,
2025, we incurred $522,000 in legal fees, $102,000 in audit fees, $50,000 in investor relation fees, $32,000 in tax preparation fees and
$6,000 in consulting fees. During the six months ended October 31, 2024, we incurred $151,000 in audit fees, $110,000 in legal fees, $86,000
in investor relation fees, $22,000 in tax preparation fees and $2,000 in consulting fees. The increase in professional fees was due mainly
to higher legal and tax preparation fees, partially offset by lower audit and investor relations fees. The increase in legal fees, which
accounted for a significant proportion of the increase, was a result of actions by the CRO from the termination of our ALZN002 clinical
trial.
26
Insurance Expense
During the six months ended
October 31, 2025 and 2024, we incurred insurance expense of $118,000 and $139,000, respectively, which was primarily directors’
and officers’ insurance.
Stock-Based Compensation Expense
During the six months ended
October 31, 2025 and 2024, we incurred general and administrative stock-based compensation expense of $74,000 and $163,000, respectively,
related to stock option grants and restricted stock grants to executives, employees and consultants. The decrease in stock-based compensation
expense for the six months ended October 31, 2025, was a result of fewer stock options vesting during the period compared to the prior
year period.
Marketing Fees
During the six months ended October 31, 2025 and 2024, we incurred
marketing fees of $150,000 and $344,000, respectively, related to the marketing and branding of our company.
Liquidity and Capital Resources
The accompanying condensed
financial statements have been prepared assuming that we will continue as a going concern. We have incurred recurring net losses and operations
have not provided sufficient cash flows. We believe that we will continue to incur operating and net losses each quarter until at least
the time we begin significant deliveries of our products. We believe our current cash on hand is
insufficient to fund our planned operations through one year after the date the condensed financial statements are issued. These factors
create substantial doubt about our ability to continue as a going concern for at least one year after the date that our condensed financial
statements are issued.
Our inability to continue as
a going concern could have a negative impact on our company, particularly if we are unable to obtain needed financing.
We intend to finance our future development activities and our working capital needs largely through the sale of equity securities with
some additional funding from other sources, including debt financing, until such time as funds provided by operations are sufficient to
fund working capital requirements. Our condensed financial statements do not include any
adjustments relating to the recoverability and classification of recorded assets, or the amounts and classifications of liabilities that
might be necessary should we be unable to continue as a going concern. As of October 31, 2025, we had cash of $4.4 million, working capital
of $4.0 million, stockholders’ equity of $4.4 million and an accumulated deficit of $62.2 million. We have incurred recurring losses
and reported losses for the three and six months ended October 31, 2025 totaling $1.0 million and $3.7 million, respectively. In the past,
we have financed our operations principally through sales of equity securities and debt instruments.
We will need to obtain substantial
additional funding in the future for our clinical development activities and continuing operations. If we are unable to raise capital
when needed or on favorable terms, we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization
efforts. Our future capital requirements will depend on many factors, including:
· successful enrollment in and completion of clinical trials;
· our ability to establish agreements with third-party manufacturers for clinical supply for our clinical
trials and, if our product candidates are approved, commercial manufacturing;
· our ability to maintain our current research and development programs and establish new research and development
programs;
· addition and retention of key research and development personnel;
· our efforts to enhance operational, financial, and information management systems, and hire additional
personnel, including personnel to support development of our product candidates;
· negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter
and performing our obligations in such collaborations;
· the timing and amount of milestone and other payments we may receive under our collaboration arrangements;
· our eventual commercialization plans for our product candidates;
27
· the costs involved in prosecuting, defending, and enforcing patent claims and other intellectual property
claims; and
· the costs and timing of regulatory approvals.
A change in the outcome of
any of these or other variables with respect to the development of any of our product candidates could significantly change the costs
and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we
may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Series C Preferred Financing
See
Note 8 Equity Transactions in the notes to the financial statements for a description of our latest fundraising activities.
Cash Flows
The following table summarizes
our cash flows for the six months ended October 31, 2025 and 2024:
For
the Six Months Ended October 31,
2025
2024
Net cash provided by (used in):
Operating activities
$ (3,534,225 )
$ (4,455,843 )
Investing activities
-
(90,000 )
Financing activities
4,035,000
8,262,868
Net increase in cash and cash equivalents
$ 500,775
$ 3,717,025
Operating Activities
During the six months ended
October 31, 2025, net cash used in operating activities was $3.5 million. This consisted primarily of a net loss of $3.7 million, partially
offset by an increase in our net operating assets and liabilities of $39,000 and by non-cash charges of $130,000. The non-cash charges
consisted of stock-based compensation expense and depreciation expense. The increase in our net operating assets and liabilities was due
to an increase in accounts payable and accrued liabilities and an increase in prepaid expenses and other current assets.
Investing Activities
During the six months ended
October 31, 2025, there was no net cash used in investing activities.
Financing Activities
During the six months ended
October 31, 2025, net cash provided by financing activities was $4.0 million from the sale of Series C Convertible Preferred Stock.
Contractual Obligations
On July 2, 2018, we entered
into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and its affiliate, the University of
South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses
limited to the field of Alzheimer’s, under U.S. Patent Nos. (i) 9,840,521, entitled “Organic Anion Lithium Ionic Cocrystal
Compounds and Compositions,” filed September 24, 2015 and granted December 12, 2017, and (ii) 9,603,869, entitled “Lithium
Co-Crystals for Treatment of Neuropsychiatric Disorders,” filed May 21, 2016 and granted March 28, 2017. On February 1, 2019, we
entered into the First Amendments to the AL001 Licenses, on March 30, 2021, we entered into the Second Amendments to the AL001 Licenses
and on June 8, 2023, we entered into the Third Amendments to the AL001 Licenses (collectively, the “AL001 License Agreements”).
The Third Amendments to the AL001 Licenses modified the timing of the payments for the license fees.
The AL001 License Agreements
require that we pay combined royalty payments of 4.5% on net sales of products developed from the licensed technology for AL001. We have
already paid an initial license fee of $200,000 for AL001. As an additional licensing fee for the license of the AL001 technologies, the
Licensor received 1,650 shares of our common stock. Minimum royalties for AL001 License Agreements are $40,000 on the first anniversary
of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and $100,000 on the third anniversary of
the first commercial sale and every year thereafter, for the life of the AL001 License Agreements.
28
On May 1, 2016, we entered
into a Standard Exclusive License Agreement with Sublicensing Terms for ALZN002 with the Licensor (the “ALZN002 License”),
pursuant to which the Licensor granted us a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy
and Diagnostics, under U.S. Patent No. 8,188,046, entitled “Amyloid Beta Peptides and Methods of Use”, filed April 7, 2009
and granted May 29, 2012. On August 18, 2017, we entered into the First Amendment to the ALZN002 License, on May 7, 2018, we entered into
the Second Amendment to the ALZN002 License, on January 31, 2019, we entered into the Third Amendment to the ALZN002 License, on January
24, 2020, we entered into the Fourth Amendment to the ALZN002 License, on March 30, 2021, we entered into the Fifth Amendment to the ALZN002
License, on April 17, 2023, we entered into the Sixth Amendment to the ALZN002 License and on December 11, 2023, we entered into the Seventh
Amendment to the ALZN002 License (collectively, the “ALZN002 License Agreement”). The Seventh Amendment to the ALZN002 License
modified the timing of the payments for the license fees.
The ALZN002 License Agreement
requires us to pay royalty payments of 4% on net sales of products developed from the licensed technology for ALZN002. We have already
paid an initial license fee of $200,000 for ALZN002. As an additional licensing fee for the license of ALZN002, the Licensor received
2,668 shares of our common stock. Minimum royalties for ALZN002 are $20,000 on the first anniversary of the first commercial sale, $40,000
on the second anniversary of the first commercial sale and $50,000 on the third anniversary of the first commercial sale and every year
thereafter, for the life of the ALZN002 License Agreement.
On November 19, 2019, we entered
into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications of AL001 with the Licensor (the
“November AL001 License”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide license limited
to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric diseases and disorders. On March 30,
2021, we entered into the First Amendments to the November AL001 License and on April 17, 2023, we entered into the Second Amendments
to the November AL001 License (collectively, the “November AL001 License Agreements”). The Second Amendments to the November
AL001 License modified the timing of the payments for the license fees.
The November AL001 License
Agreements require us to pay royalty payments of 3% on net sales of products developed from the licensed technology for AL001 in those
fields. We paid an initial license fee of $20,000 for the additional indications. Minimum royalties for November AL001 License Agreements
are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and
$100,000 on the third anniversary of the first commercial sale and every year thereafter, for the life of the November AL001 License Agreements.
These license agreements have
an indefinite term that continue until the later of the date that no licensed patent under the applicable agreement remains a pending
application or enforceable patent, the end date of any period of market exclusivity granted by a governmental regulatory body, or the
date on which the licensee’s obligations to pay royalties expire under the applicable license agreement. Under our various license
agreements, if we fail to meet a milestone by its specified date, Licensor may terminate the license agreement. The Licensor was also
granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by us while the Licensor
remains the owner of any equity securities of our company.
Additionally, we are required
to pay milestone payments on the due dates to the Licensor for the license of the AL001 technologies and for the ALZN002 technology, as
follows:
Original AL001 Licenses:
Payment
Due Date
$
50,000*
Pre-IND Meeting - Completed September 2019
$
65,000*
IND application filing - Completed June 2021
$
190,000*
Upon first dosing of patient in a clinical trial - Completed December 2021
$
500,000*
Upon completion of first clinical trial - Completed March 2022
$
1,250,000
Upon first patient treated in a Phase III clinical trial
$
10,000,000
Upon FDA NDA approval
* Milestone met and completed
ALZN002 License:
Payment
Due Date
$
50,000*
Upon IND application - Completed January 2022
$
50,000
Upon first dosing of patient in first Phase I clinical trial
$
500,000
Upon completion of first Phase IIB clinical trial
$
1,000,000
Upon first patient treated in a Phase III clinical trial
$
10,000,000
Upon first commercial sale
* Milestone met and completed
29
Additional AL001 Licenses:
Payment
Due Date
$
2,000,000
Upon first patient treated in a Phase III clinical trial
$
16,000,000
First commercial sale
Recent Accounting Standards
None.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Because we are a smaller reporting
company, this section is not applicable.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure
Controls and Procedures
We have established disclosure
controls and procedures designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange
Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and is accumulated and communicated
to management, including the principal executive officer and principal financial officer, to allow timely decisions regarding required
disclosure.
Our principal executive officer
and principal financial officer, with the assistance of other members of the Company’s management, have evaluated the effectiveness
of the design and operation of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under
the Exchange Act) as of the end of the period covered by this quarterly report. Based upon our evaluation, each of our principal executive
officer and principal financial officer has concluded that the Company’s internal control over financial reporting was not effective
as of the end of the period covered by this Quarterly Report on Form 10-Q because the Company has not yet completed its remediation of
the material weakness previously identified and disclosed in the Company’s Annual Report on Form 10-K for the year ended April 30,
2025, the end of its most recent fiscal year.
Specifically, management has
identified the following material weakness:
We do not have sufficient
resources in our accounting department, which restricts our ability to perform sufficient reviews and approval of manual journal entries
posted to the general ledger and to consistently execute review procedures over general ledger account reconciliations, financial statement
preparation and accounting for non-routine transactions.
A material weakness is a control
deficiency or combination of control deficiencies that result in more than a remote likelihood that a material misstatement of the annual
or interim financial statements will not be prevented or detected.
Planned Remediation
We are implementing measures
designed to improve our internal control over financial reporting to remediate material weaknesses, including continuing to formalize
our internal control documentation and strengthening supervisory reviews by our management.
Management will continue to
implement measures to remediate material weaknesses, such that these controls are designed, implemented, and operating effectively. Given
our limited resources, we will need to increase our accounting department in the future to fully remediate our current weakness. The material
weakness will not be considered to be remediated until the applicable remediated controls are operating for a sufficient period of time
and management has concluded, through testing, that these controls are operating effectively.
Despite the existence of our
control deficiency, we believe that the condensed financial statements included in the period covered by this Quarterly Report on Form
10-Q fairly present, in all material respects, our financial condition, results of operations and cash flows for the periods presented
in conformity with U.S. generally accepted accounting principles.
Changes in Internal Control
During the quarter ended October
31, 2025, there was no change in our internal control over financial reporting that materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
30
PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we may
be subject to legal proceedings. We are not currently a party to or aware of any proceedings that we believe will have, individually or
in the aggregate, a material adverse effect on our business, financial condition or results of operations. Regardless of the outcome,
litigation can have an adverse impact on us because of defense and settlement costs, diversion of management resources, and other factors.
ITEM 1A. RISK FACTORS
The risks described in Part
I, Item 1A, “Risk Factors,” in our 2025 Annual Report on Form 10-K, could materially and adversely affect our business,
financial condition and results of operations, and the trading price of our Common Stock could decline. These risk factors do not identify
all risks that we face; our operations could also be affected by factors that are not presently known to us or that we currently consider
to be immaterial to our operations. Due to risks and uncertainties, known and unknown, our past financial results may not be a reliable
indicator of future performance and historical trends should not be used to anticipate results or trends in future periods. The Risk Factors
section of our 2025 Annual Report on Form 10-K remains current in all material respects.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
None of the Company’s
directors and officers adopted , modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during
the Company's fiscal quarter ended October 31, 2025 (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of
1934, as amended).
ITEM 6. EXHIBITS
Exhibit
No.
Exhibit Description
3.1
Certificate of Incorporation (incorporated by reference to Exhibit 2.1 of Form DOS filed with the SEC on August 19, 2016).
3.2
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on June 10, 2016 (incorporated by reference to Exhibit 3.2 of the Quarterly Report on Form 10-Q filed with the SEC on December 15, 2023).
3.3
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on December 22, 2020 (incorporated by reference to Exhibit 3.3 of the Quarterly Report on Form 10-Q filed with the SEC on December 15, 2023).
3.4
Certificate of Amendment to the Certificate of Incorporation, filed with the Delaware Secretary of State on October 27, 2023 (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K filed with the SEC on October 30, 2023).
3.8
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the registration statement on Form S-1 filed with the SEC on May 10, 2021).
3.9
First Amendment to the Amended and Restated Bylaws (incorporated by reference to Exhibit 3.1 of the Current Report on Form 8-K filed with the SEC on March 3, 2025).
31.1*
Certification of Chief Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a).
31.2*
Certification of Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a).
32.1**
Certification of Chief Executive and Financial Officer required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code.
101.INS*
XBRL Instance Document. The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH*
Inline XBRL Taxonomy Extension Schema Document.
101.CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
31
101.DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
*Filed herewith.
** This certification will not be deemed “filed”
for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section. Such certification will not be
deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the
extent specifically incorporated by reference into such filing.
32
SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
ALZAMEND NEURO, INC.
Date: December 9, 2025
By:
/s/ Stephan Jackman
Stephan Jackman
Chief Executive Officer (principal executive officer)
Date: December 9, 2025
By:
/s/ David J. Katzoff
David J. Katzoff
Chief Financial Officer (principal financial and accounting officer)
33
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.