ALZN 10-Q
Alzamend Neuro, Inc. (ALZN)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number:
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
| ( | ||
| (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 |
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.
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).
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 ¨ |
| x | Smaller reporting company | |
| Emerging growth company |
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 ¨
As of September 10, 2026 there were 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 | 7 | |
| Notes to Condensed Financial Statements | 8 | |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 17 |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 24 |
| Item 4. | Controls and Procedures | 24 |
| PART II. | OTHER INFORMATION | 26 |
| Item 1. | Legal Proceedings | 26 |
| Item 1A. | Risk Factors | 26 |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 26 |
| Item 3. | Defaults Upon Senior Securities | 26 |
| Item 4. | Mine Safety Disclosures | 26 |
| Item 5. | Other Information | 26 |
| Item 6. | Exhibits | 26 |
| Signatures | 28 |
| 2 |
PART I – FINANCIAL INFORMATION
| ITEM 1. | FINANCIAL STATEMENTS |
Alzamend Neuro, Inc.
Condensed Balance Sheets
| July 31, 2026 | April 30, 2026 | |||||||
| ASSETS | (Unaudited) | (Audited) | ||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| TOTAL CURRENT ASSETS | ||||||||
| Property, plant and equipment, net | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | $ | ||||||
| TOTAL LIABILITIES, ALL CURRENT | ||||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| STOCKHOLDERS’ EQUITY | ||||||||
| Series D Convertible Preferred Stock, $ par value, $ stated value per share, and nil shares designated; and nil issued and outstanding as of July 31, 2026 and April 30, 2026, respectively | ||||||||
| Common stock, $ par value: shares authorized; and issued and outstanding as of July 31, 2026 and April 30, 2026, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| TOTAL STOCKHOLDERS’ EQUITY | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | ||||||
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 July 31, | ||||||||
| 2026 | 2025 | |||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | $ | ||||||
| General and administrative | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| OTHER EXPENSE, NET | ||||||||
| Interest income | ||||||||
| Interest expense | ( | ) | ( | ) | ||||
| Total other expense, net | ( | ) | ( | ) | ||||
| NET LOSS | $ | ( | ) | $ | ( | ) | ||
| Basic and diluted net loss per common share | $ | ) | $ | ) | ||||
| Basic and diluted weighted average common shares outstanding | ||||||||
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 July 31, 2026
(Unaudited)
| Series D Convertible | Additional | |||||||||||||||||||||||||||
| Preferred Stock | Common Stock | Paid-In | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||
| BALANCES, April 30, 2026 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Issuance of common stock for cash, net of issuance costs | ||||||||||||||||||||||||||||
| Issuance of preferred stock for cash, net of issuance costs | - | |||||||||||||||||||||||||||
| Stock-based compensation to employees, directors and consultants | - | - | ||||||||||||||||||||||||||
| Net loss | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| BALANCES, July 31, 2026 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
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 July 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 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||
| Issuance of preferred stock for cash, net of issuance costs | - | - | ||||||||||||||||||||||||||||||||||
| Conversion of preferred stock to common stock | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Stock-based compensation to employees and consultants | - | - | - | |||||||||||||||||||||||||||||||||
| Net loss | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||
| BALANCES, July 31, 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
| 6 |
Alzamend Neuro, Inc.
Condensed Statements of Cash Flows
(Unaudited)
| For the Three Months Ended July 31, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation expense | ||||||||
| Stock-based compensation to employees, directors and consultants | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Accounts payable and accrued liabilities | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Net proceeds from the issuance of common stock | ||||||||
| Net proceeds from the issuance of preferred stock, net | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase in cash | ||||||||
| Cash at beginning of period | ||||||||
| Cash at end of period | $ | $ | ||||||
| Supplemental disclosures of cash flow information: | ||||||||
| Non-cash financing activities: | ||||||||
| Conversion of Series B convertible preferred stock to common stock | $ | $ | ||||||
| Conversion of Series C convertible preferred stock to common stock | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed financial statements.
| 7 |
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 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 to 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 $ per share (“Common Stock”) and its preferred stock, par value $ per share. The Company expects to continue to incur net losses for the foreseeable future.
Reverse Stock 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 “Reverse Split”). The Reverse Split did not affect the number of authorized shares of Common Stock, preferred stock or their respective par value per share. As a result of the Reverse Split, each nine shares of Common Stock issued and outstanding prior to the Reverse Split were converted into one share of Common Stock. The Reverse Split became effective in the State of Delaware on May 12, 2025. All share amounts in these condensed financial statements have been updated for all periods presented to reflect the Reverse Split.
| 2. | LIQUIDITY AND GOING CONCERN |
The accompanying condensed
financial statements have been prepared on the basis that the Company will continue as a going concern. As of July 31, 2026, the Company
had cash of $
The Company expects to continue to incur losses for the foreseeable future and will need to continue raising 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 the Company’s 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 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 and future prospects.
| 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, 2026, filed with the SEC on July 22, 2026. 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, 2026 has been derived from the audited balance sheet at April 30, 2026 contained in such Form 10-K.
| 8 |
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 July 31, 2026
and April 30, 2026, the Company had
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.
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.
| 9 |
The Company recognizes stock-based compensation expense for restricted stock units on a straight-line basis over the requisite service period and accounts for forfeitures as they occur. The Company’s stock-based compensation for issuances of restricted stock is based upon the estimated fair value of the Common Stock.
The Black-Scholes option pricing model utilizes inputs that 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 impacted.
Warrants
The Company accounts for 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.
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 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 warrants, 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.
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 similarly 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:
| For the Three Months Ended July 31, | ||||||||
| 2026 | 2025 | |||||||
| Stock options | ||||||||
| Warrants | ||||||||
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.
| 10 |
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 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:
| July 31, 2026 | April 30, 2026 | |||||||
| Prepaid clinical trial expenses | $ | $ | ||||||
| Prepaid insurance | ||||||||
| Other prepaid expenses | ||||||||
| Total prepaid expenses and other current assets | $ | $ | ||||||
Prepaid clinical trial expenses at July 31, 2026, represented the unamortized portion of prepaid clinical trial expense and will be amortized as used, which the Company’s management estimated to be over the next six months.
On June 9, 2026, the Company
purchased directors’ and officers’ insurance for 12 months in the amount of $
| 5. | STOCK-BASED COMPENSATION |
2021 Stock Incentive Plan
In February 2021, the Company’s stockholders approved the Company’s 2021 Stock Incentive Plan (the “2021 Plan”). The 2021 Plan provides for the issuance of a maximum of shares of Common Stock to be offered to the Company’s directors, officers, employees, and consultants. Options granted under the 2021 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 years from the date of grant.
2025 Stock Incentive Plan
In April 2026, the Company’s stockholders approved the Company’s 2025 Stock Incentive Plan (the “2025 Plan”). The 2025 Plan authorizes the grant to eligible individuals of (1) stock options (incentive and non-statutory), (2) restricted stock, (3) stock appreciation rights, or SARs, (4) restricted stock units, and (5) other stock-based compensation.
Stock Subject to the 2025 Plan. The maximum number of shares of Common Stock that may be issued under the 2025 Plan is 1,600,000 shares, which number will be increased to the extent that compensation granted under the 2025 Plan is forfeited, expires or is settled for cash (except as otherwise provided in the 2025 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 2025 Plan, nor will shares subject to a substitute award be added to the shares available for issuance or transfer under the 2025 Plan.
| 11 |
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 of the average of the vesting period and the term of the option. 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 three months ended July 31, 2026 is presented below:
| 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, 2026 | $ | $ | ||||||||||||||||||
| Options granted | $ | - | ||||||||||||||||||
| Options exercised | $ | - | ||||||||||||||||||
| Options expired | $ | - | ||||||||||||||||||
| Balance at July 31, 2026 | $ | $ | ||||||||||||||||||
| Options vested and expected to vest at July 31, 2026 | $ | $ | ||||||||||||||||||
| Options exercisable at July 31, 2026 | $ | $ | ||||||||||||||||||
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 Company’s board of directors (the “Board”) granted 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.
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 July 31, 2026, 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 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 July 31, 2026, 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.
| 12 |
Stock-Based Compensation Expense
The Company’s results of operations, which included expenses relating to stock-based compensation for three months ended July 31, 2026 and 2025, were comprised as follows:
| For the Three Months Ended July 31, | ||||||||
| 2026 | 2025 | |||||||
| Research and development | $ | $ | ||||||
| General and administrative | ||||||||
| Total | $ | $ | ||||||
As of July 31, 2026, total unamortized stock-based compensation expense related to unvested employee and non-employee awards that were expected to vest was $. The weighted-average period over which such stock-based compensation expense will be recognized was approximately years.
| 6. | WARRANTS |
Warrant activity for the three months ended July 31, 2026 is presented below:
|
Number Outstanding |
Weighted Average Exercise Price |
||||||
| Outstanding at April 30, 2026 | $ |
||||||
| Cancelled/Expired | ) | $ | |||||
| Outstanding at July 31, 2026 | $ |
||||||
The following table summarizes information about Common Stock warrants outstanding and exercisable at July 31, 2026:
| Outstanding | Exercisable | ||||||||||||||||||||
| Weighted | |||||||||||||||||||||
| Average | Weighted | Weighted | |||||||||||||||||||
| Remaining | Average | Average | |||||||||||||||||||
| Exercise | Number | Contractual | Exercise | Number | Exercise | ||||||||||||||||
| Price | Outstanding | Life (years) | Price | Exercisable | Price | ||||||||||||||||
| $ | $ | $ | |||||||||||||||||||
| $ | $ | $ | |||||||||||||||||||
| $ | $ | $ | |||||||||||||||||||
| $ | $ | $ | |||||||||||||||||||
| 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.
| 13 |
The
AL001 License Agreements require that the Company pay combined royalty payments of
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
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
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:
| Payment | Due Date | |
| $ | ||
| $ | ||
| $ | ||
| $ | ||
| $ | ||
| $ | ||
| * |
| 14 |
ALZN002 License:
| Payment | Due Date | |
| $ | ||
| $ | ||
| $ | ||
| $ | ||
| $ | ||
| * |
Additional AL001 Licenses:
| Payment | Due Date | |
| $ | ||
| $ | ||
| 8. | EQUITY TRANSACTIONS |
The Company is authorized to issue shares of Preferred Stock, $ par value. The Board has designated shares as Series D Convertible Preferred Stock. The rights, preferences, privileges and restrictions of the remaining authorized 9,975,000 shares of Preferred Stock have not been determined. The Board is authorized to create a new series of preferred shares and determine the number of shares, as well as the rights, preferences, privileges and restrictions granted to or imposed upon any series of preferred shares.
Series D Convertible Preferred Stock
On July 31, 2026, 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 shares of Series D convertible preferred stock (“Series D Preferred
Stock”). The AL SPA provides that Ault Lending shall, subject to certain conditions, purchase up to $
On July 31, 2026, the Company
sold shares of Series D Preferred Stock for a total purchase price of $
Pursuant to the AL SPA,
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The Series D Preferred Stock has a stated value of $1,000 per share (“Stated Value”) and does not accrue dividends. Each share of Series D Preferred Stock is convertible into a number of shares of Common Stock determined by dividing the Stated Value by the greater of (i) $0.2668 (the “Floor Price”) and (ii) 80% of the lowest closing bid price of the Common Stock during the five (5) trading days immediately prior to the date of conversion into Conversion Shares, but not greater than $2.00 per share (the “Maximum Price”) (“the Conversion Price”). The Conversion Price is subject to adjustment in the event of issuances 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 D 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 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 D Preferred Stock is entitled to cast, shall not be lower than $1.4175 (the “Voting Floor Price”), which represents the closing sale price of the Common Stock on the trading day immediately prior to the Execution Date, $1.35, multiplied by 1.05. 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 D Preferred Stock will receive a liquidation preference ahead of common stockholders.
The Company agreed to use its best efforts to file a registration statement, registering for resale the shares of Common Stock issuable upon conversion of the Series D Preferred Stock (the “Initial Required Registration Amount “) with the SEC by August 15, 2026 (the “Filing Deadline”). The Company also agreed that if: (i) the registration statement is not filed on or prior to its Filing Deadline, or (ii) a registration statement registering for resale all of the Initial Required Registration Amount is not declared effective by the SEC by the 60th calendar day following the Filing Deadline (or, in the event of a “full review” by the SEC, the 90th calendar day following the Filing Deadline) of the registration statement (any such failure or breach being referred to as an “Registration Default”), and on any date such a Registration Default has occurred (a “Registration Default Date”), then, in addition to any other rights Ault Lending may have under the AL SPA, its related transaction documents or under applicable law, on each such Registration Default Date and on each monthly anniversary of each such Registration Default Date (if the applicable Registration Default shall not have been cured by such date) until the applicable Registration Default is cured, the Company shall pay to Ault Lending, as partial liquidated damages and not as a penalty, an amount in cash equal to two percent (2%) of the Stated Value of the Series D Preferred Stock held, not to exceed fifteen percent (15%) in the aggregate. The Company has received a waiver of the late filing penalties from Ault Lending.
In addition, the Company agreed to use its best efforts to file a preliminary proxy statement no later than 15 days after the Execution Date and thereafter use its reasonable best efforts to file a definitive proxy statement related to a special meeting of the Company’s stockholders within 45 days of the Execution Date for purposes of seeking stockholder approval of the issuance of all the Conversion Shares in excess of the “Nasdaq Limit,” which is 19.99% of the shares of Common Stock issued and outstanding on the Execution Date. The special meeting shall occur no later than seventy-five (75) days after the Execution Date.
Common Stock
On March 6, 2026, the Company entered into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC as sales agent to sell shares of its Common Stock, having an aggregate offering price of up to approximately $3.0 million (the “2026 Shares”) from time to time, through an “at the market offering” (the “2026 ATM”) as defined in Rule 415 under the Securities Act. On March 6, 2026, the Company filed a prospectus supplement with the SEC relating to the offer and sale of the 2026 Shares in the 2026 ATM.
The offer and sale of the 2026 Shares was made pursuant to the Company’s effective “shelf” registration statement on Form S-3 and an accompanying base prospectus contained therein (Registration Statement No. 333-273610) filed with the SEC on August 2, 2023 and declared effective by the SEC on August 10, 2023.
During the three months ended
July 31, 2026, the Company sold an aggregate of shares of Common Stock pursuant to the 2026 ATM for proceeds of $
The 2026 ATM was terminated on August 10, 2026, with the expiration of Registration Statement No. 333-276610.
| 9. | SUBSEQUENT EVENTS |
Management has evaluated subsequent events through the date the financial statements were issued. Management has determined that there are no such events that warrant disclosure or recognition in the condensed financial statements presented herein.
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| 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, 2026.
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. |
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| · | 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 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.
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.
| 18 |
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 a partnership with Massachusetts General Hospital (“MGH”) and Harvard Medical School to conduct five Phase II imaging clinical trials. The purpose of these trials is to assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among healthy subjects and patients afflicted with Alzheimer’s, BD, MDD and PTSD.
In November 2024, we announced a full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer’s transgenic mice. This study was a precursor to the five clinical trials and showed that AL001 exhibited consistently higher lithium concentrations in brain tissues, particularly at lower doses, compared to lithium carbonate.
For these clinical trials, we partnered with Tesla Dynamic Coils BV to create a head coil to enable whole-brain imaging of lithium with remarkable resolution, allowing precise quantification within brain structures. The coil will be used to help identify the disease-specific target doses of AL001 that improve the balance of safety and efficacy compared to lithium carbonate. The coil will also be used to scan the entire brain, helping us clearly identify the different structures and important areas necessary for understanding how lithium works and moves within the brain. We announced completion of the head coil in February 2025.
In May 2025, we announced the initiation, enrollment and dosing of the first patient for the healthy human patients. This clinical trial has the following objectives:
| · | To assess lithium brain/plasma pharmacokinetics (“PK”) of the AL001 oral capsule relative to a marketed lithium carbonate capsule in healthy adult subjects for the purpose of determining potential clinically safe and effective AL001 dosing in future studies; |
| · | To characterize AL001 lithium and salicylate steady-state plasma PK, and lithium relative to a marketed lithium carbonate capsule; |
| · | To characterize differences in brain and brain structure(s) PK behaviors such as absorption and persistence between AL001 capsule and a marketed lithium carbonate capsule; and |
| · | To characterize safety and tolerability of the tested formulations under the conditions of this study (38% below the pre-determined MTD for AL001, at a half-dose of a usual lithium starting dose of lithium carbonate for treatment of BD, equivalent to 150 mg lithium carbonate TID). |
In November 2025, we announced the completion of the clinical portion of this study and reported pharmacokinetics topline data in March 2026, with the following results: (1) Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium carbonate; (2) Superior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain regions, including whole brain; and (3) Faster Brain Uptake: AL001 reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonate. In April 2026, we announced pharmacodynamic topline data of the healthy human subjects with the following results:
| · | Potentially Distinct Brain Profile: Across multiple brain regions, AL001 and lithium carbonate appeared to trend in opposite directions in brain chemistry measures, suggesting that AL001 may interact with the brain in a distinct manner and generate a lower neurochemical footprint than lithium carbonate; |
| · | Expected Trends for Myo-Inositol Reduction: Both AL001 and lithium carbonate showed a trend toward reducing myo-inositol, potentially supporting the hypothesis that AL001 retains lithium's core mechanism of action; and |
| · | Potentially Preserved Glutamate Balance: Lithium carbonate showed large effects across all brain regions whereas AL001 showed minimal glutamate effect in most brain regions, which may suggest better long-term tolerability. |
Full pharmacokinetic and pharmacodynamic results are expected in the fourth quarter of 2026.
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In March 2026, we announced the initiation of the Phase II Clinical Trial of AL001 “Lithium in Brain” Study in Patients with BD and expect to report topline data in the fourth quarter of 2026. The clinical trials for treatment of patients with MDD and PTSD are expected to commence in the fourth quarter of 2026, followed by Alzheimer’s in the first quarter of 2027. These projected timelines reflect our commitment to advancing our clinical development programs across multiple neuropsychiatric and neurodegenerative indications.
On September 28, 2022, we submitted an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (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 Biorasi, LLC (“Biorasi”), the company formerly engaged as our contract research organization (“CRO”), terminating our contract with Biorasi. We are currently pursuing the engagement of a replacement CRO. Due to the scientific and operational complexities of the ALZN002 trial, along with the limited number of CROs with the expertise and capacity to complete the trial, we have experienced a delay in engaging a new CRO. We do not expect to restart this trial until the second quarter of 2027.
The continuation of our current plan of operations with respect to completing our IND applications 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 July 31, 2026 and 2025
The following table summarizes the results of our operations for the three months ended July 31, 2026 and 2025:
| For the Three Months Ended July 31, | ||||||||||||||||
| 2026 | 2025 | $ Change | % Change | |||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and development | $ | 1,085,998 | $ | 1,740,867 | $ | (654,869 | ) | -38 | % | |||||||
| General and administrative | 1,939,398 | 959,334 | 980,064 | 102 | % | |||||||||||
| Total operating expenses | 3,025,396 | 2,700,201 | 325,195 | 12 | % | |||||||||||
| Loss from operations | (3,025,396 | ) | (2,700,201 | ) | (325,195 | ) | 12 | % | ||||||||
| OTHER INCOME (EXPENSE), NET | ||||||||||||||||
| Interest income | 399 | - | 399 | * | ||||||||||||
| Interest expense | (2,005 | ) | (2,483 | ) | 478 | -19 | % | |||||||||
| Total other expense, net | (1,606 | ) | (2,483 | ) | 877 | -35 | % | |||||||||
| NET LOSS | $ | (3,027,002 | ) | $ | (2,702,684 | ) | $ | (324,318 | ) | -12 | % | |||||
| Basic and diluted net loss per common share | $ | (0.68 | ) | $ | (1.28 | ) | $ | 0.60 | * | |||||||
| Basic and diluted weighted average common shares outstanding | 4,478,709 | 2,106,036 | * | |||||||||||||
| * | Not meaningful |
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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, whether we or a third party conducts such 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 July 31, 2026 and 2025, 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 July 31, 2026 and 2025 were $1.1 million and $1.7 million, 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 July 31, | ||||||||||||||||
| 2026 | 2025 | $ Change | % Change | |||||||||||||
| Professional fees | $ | 146,093 | $ | 73,809 | $ | 72,284 | 98 | % | ||||||||
| Stock-based compensation expense | 5,826 | - | 5,826 | * | ||||||||||||
| Clinical trial fees | 929,385 | 1,661,384 | (731,999 | ) | -44 | % | ||||||||||
| Other research and development expenses | 4,694 | 5,674 | (980 | ) | -17 | % | ||||||||||
| Total research and development expenses | $ | 1,085,998 | $ | 1,740,867 | $ | (654,869 | ) | -38 | % | |||||||
| * | Not meaningful |
Professional Fees
During the three months ended July 31, 2026 and 2025, we incurred professional fees of $146,000 and $74,000, respectively, which were primarily comprised of professional fees attributed to various types of scientific services, including FDA consulting services. The increase relates to higher professional fees required to support the current and upcoming clinical trial activities.
Stock-Based Compensation Expense
During the three months ended July 31, 2026, we incurred $6,000 of research and development stock-based compensation expense related to stock option grants to consultants. No such expense was incurred during the three months ended July 31, 2025. The increase in research and development stock-based compensation expense for the three months ended July 31, 2026 was a result of the vesting of stock options.
Clinical Trial Fees
During the three months ended July 31, 2026 and 2025, we incurred clinical trial fees of $929,000 and $1.7 million, respectively. Clinical trial fees for the three months ended July 31, 2026 were for our Phase IIB clinical study on BD subjects conducted with MGH, which we expect to complete in September 2026. Clinical trial fees for the three months ended July 31, 2025 were for our Phase IIA brain imaging study with MGH which completed during the three months ended July 31, 2025.
Other Research and Development Expenses
During the three months ended July 31, 2026 and 2025, we incurred other fees of $5,000 and $6,000, respectively, which were primarily comprised of scientific materials required for our clinical trials.
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General and Administrative Expenses
General and administrative expenses for the three months ended July 31, 2026 and 2025 were $1.9 million and $959,000, 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 July 31, 2026 and 2025, the remaining general and administrative expenses of $162,000 and $102,000, 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 July 31, | ||||||||||||||||
| 2026 | 2025 | $ Change | % Change | |||||||||||||
| Salary and benefits | $ | 222,369 | $ | 227,930 | $ | (5,561 | ) | -2 | % | |||||||
| Professional fees | 1,377,153 | 333,391 | 1,043,762 | 313 | % | |||||||||||
| Insurance | 56,392 | 59,708 | (3,316 | ) | -6 | % | ||||||||||
| Stock-based compensation expense | 71,373 | 42,902 | 28,471 | 66 | % | |||||||||||
| Marketing fees | - | 150,000 | (150,000 | ) | * | |||||||||||
| Board of director fees | 50,000 | 43,750 | 6,250 | 14 | % | |||||||||||
| Other general and administrative expenses | 162,111 | 101,653 | 60,458 | 59 | % | |||||||||||
| Total general and administrative expenses | $ | 1,939,398 | $ | 959,334 | $ | 980,064 | 102 | % | ||||||||
Salaries and Benefits
During each of the three months ended July 31, 2026 and 2025, we incurred salaries and benefits of $222,000 and $228,000, respectively. We reduced our headcount by one part-time employee. As of July 31, 2026, we had four full-time and two part-time employees.
Professional Fees
During the three months ended July 31, 2026 and 2025, we incurred professional fees of $1.4 million and $333,000, respectively. During the three months ended July 31, 2026, we incurred $1.3 million in legal fees, $85,000 in audit fees, $19,000 in tax preparation fees and $6,000 in investor relations fees. During the three months ended July 31, 2025, we incurred $183,000 in legal fees, $78,000 in audit fees, $60,000 in investor relations fees and $12,000 in tax preparation fees. The increase in professional fees was due mainly to higher legal, audit and tax preparation fees, partially offset by lower investor relations fees. The increase in legal fees was a result of increased activity in our lawsuit against Biorasi for terminating their agreement. The trial in that lawsuit has commenced and is expected to be completed by the end of December 2026.
Insurance Expense
During the three months ended July 31, 2026 and 2025, we incurred insurance expenses of $56,000 and $60,000, respectively, which were primarily directors’ and officers’ insurance.
Stock-Based Compensation Expense
During the three months ended July 31, 2026 and 2025, we incurred general and administrative stock-based compensation expense of $71,000 and $43,000, respectively, related to stock option grants to executives, employees and consultants. The increase in stock-based compensation expense for the three months ended July 31, 2026 was a result of a greater number of stock option vesting.
Marketing Fees
During the three months ended July 31, 2025, we incurred marketing fees of $150,000, which primarily represented expenses related to the marketing and branding of our company. We did not incur any marketing fees during the three months ended July 31, 2026.
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 our operations have not generated any 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.
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Our inability to continue as a going concern could have a negative impact on our company, particularly if we are unable to obtain the requisite 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 July 31, 2026, we had cash of $7.6 million and an accumulated deficit of $70.3 million. We have incurred recurring losses and reported losses for the three months ended July 31, 2026 totaling $3.0 million. In the past, we have financed our operations principally through issuances of equity 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, whether undertaken by our company or a third party; |
| · | our ability to maintain our current research and development programs and establish new research and development programs; |
| · | addition and retention of key research and development personnel; |
| · | our efforts to enhance operational, financial, and information management systems, and hire additional personnel, including personnel to support development of our product candidates; |
| · | negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter and performing our obligations in such collaborations; |
| · | the timing and amount of milestone and other payments we may receive under our collaboration arrangements; |
| · | our eventual commercialization plans for our product candidates; |
| · | the costs involved in prosecuting, defending, and enforcing patent claims and other intellectual property claims; and |
| · | the costs and timing of regulatory approvals. |
A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Series D Preferred Financing
See Note 8 Equity Transactions in the notes to the financial statements for a description of our latest fundraising activities.
At-the-Market Offering
See Note 8 Equity Transactions in the notes to the financial statements for a description of our latest fundraising activities.
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Cash Flows
The following table summarizes our cash flows for the three months ended July 31, 2026 and 2025:
| For the Three Months Ended July 31, | ||||||||
| 2026 | 2025 | |||||||
| Net cash provided by (used in): | ||||||||
| Operating activities | $ | (1,138,517 | ) | $ | (2,362,786 | ) | ||
| Investing activities | - | - | ||||||
| Financing activities | 8,019,272 | 4,035,000 | ||||||
| Net increase in cash and cash equivalents | $ | 6,880,755 | $ | 1,672,214 | ||||
Operating Activities
During the three months ended July 31, 2026, net cash used in operating activities was $1.1 million. This consisted primarily of a net loss of $3.0 million, partially offset by an increase in our net operating assets and liabilities of $1.8 million and by non-cash charges of $105,000. 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 a decrease in prepaid expenses and other current assets.
Investing Activities
During the three months ended July 31, 2026, no net cash was used in investing activities.
Financing Activities
During the three months ended July 31, 2026, net cash provided by financing activities was $7.4 million from the sale of Series D Preferred Stock and $669,000 from the sale of Common Stock from our ATM.
Contractual Obligations
See Note 7 Commitments and Contingencies in the notes to the condensed financial statements for a description of our contractual obligations.
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, 2026, the end of its most recent fiscal year.
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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 material weakness, 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 July 31, 2026, 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.
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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 2026 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 2026 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 July 31, 2026 (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).
| ITEM 6. | EXHIBITS |
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*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.
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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: September 10, 2026 | By: |
/s/ Stephan Jackman Stephan Jackman | |
| Date: September 10, 2026 | By: |
/s/ David J. Katzoff David J. Katzoff |
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