PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) Alzamend Neuro's unaudited Q1 2025 financial statements, including balance sheets, operations, equity, cash flows, and notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Balance Sheet Summary | Metric | July 31, 2025 (Unaudited) ($) | April 30, 2025 (Audited) ($) | | :-------------------------------- | :------------------------ | :----------------------- | | Cash | $5,620,872 | $3,948,658 | | Total Current Assets | $5,928,830 | $4,177,377 | | Total Assets | $6,326,751 | $4,602,983 | | Accounts payable and accrued liabilities | $983,311 | $634,761 | | Total Liabilities, All Current | $983,311 | $634,761 | | Total Stockholders' Equity | $5,343,440 | $3,968,222 | | Total Liabilities and Stockholders' Equity | $6,326,751 | $4,602,983 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Statements of Operations Summary | Metric | For the Three Months Ended July 31, 2025 ($) | For the Three Months Ended July 31, 2024 ($) | | :--------------------------------- | :------------------------------------- | :------------------------------------- | | Research and development | $1,740,867 | $206,571 | | General and administrative | $959,334 | $755,834 | | Total operating expenses | $2,700,201 | $962,405 | | Loss from operations | $(2,700,201) | $(962,405) | | Interest expense | $(2,483) | $(12,006) | | NET LOSS | $(2,702,684) | $(974,411) | | Basic and diluted net loss per common share | $(1.28) | $(11.42) | | Basic and diluted weighted average common shares outstanding | 2,106,036 | 85,314 | [Condensed Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Statements%20of%20Stockholders%27%20Equity) Stockholders' Equity Summary | Item | April 30, 2025 | July 31, 2025 | | :------------------------------------------ | :------------- | :------------ | | Common Stock Shares Outstanding | 778,733 | 3,139,861 | | Common Stock Amount | $78 | $314 | | Additional Paid-In Capital | $62,503,405 | $66,581,071 | | Accumulated Deficit | $(58,535,261) | $(61,237,945) | | Total Stockholders' Equity | $3,968,222 | $5,343,440 | | Issuance of preferred stock for cash, net | - | $4,035,000 | | Conversion of preferred stock to common stock | - | $0 (2,361,128 shares) | | Stock-based compensation | - | $42,902 | | Net loss | - | $(2,702,684) | - The company issued preferred stock for cash, net of issuance costs, totaling **$4,035,000** during the three months ended July 31, 2025[15](index=15&type=chunk) - Conversion of preferred stock to common stock resulted in **2,361,128 new common shares** during the three months ended July 31, 2025[15](index=15&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Cash Flow Summary | Cash Flow Activity | For the Three Months Ended July 31, 2025 ($) | For the Three Months Ended July 31, 2024 ($) | | :----------------------------------- | :------------------------------------- | :------------------------------------- | | Net cash used in operating activities | $(2,362,786) | $(1,055,742) | | Net cash used in investing activities | $- | $(90,000) | | Net cash provided by financing activities | $4,035,000 | $1,963,644 | | Net increase in cash | $1,672,214 | $817,902 | | Cash at end of period | $5,620,872 | $1,193,950 | - Non-cash financing activities for the three months ended July 31, 2025, included the conversion of Series B convertible preferred stock (**$564,755**) and Series C convertible preferred stock (**$5,757,176**)[21](index=21&type=chunk) [Notes to Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) [1. DESCRIPTION OF BUSINESS](index=8&type=section&id=1.%20DESCRIPTION%20OF%20BUSINESS) - Alzamend Neuro, Inc. is a clinical-stage biopharmaceutical company focused on developing novel products for Alzheimer's disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD)[24](index=24&type=chunk) - The company's pipeline includes two therapeutic drug candidates: AL001 (an ionic cocrystal technology for lithium delivery) and ALZN002 (a cell-based therapeutic vaccine for Alzheimer's)[24](index=24&type=chunk) - The company has not generated any product revenue to date and expects to incur net losses for the foreseeable future, financing operations primarily through debt and equity issuances[25](index=25&type=chunk) - The company effected two reverse stock splits: a **one-for-ten split** on July 16, 2024, and a **one-for-nine split** on May 12, 2025, to adjust its issued and outstanding common stock[26](index=26&type=chunk)[27](index=27&type=chunk) [2. LIQUIDITY AND GOING CONCERN](index=8&type=section&id=2.%20LIQUIDITY%20AND%20GOING%20CONCERN) - As of July 31, 2025, the company had **$5.6 million** in cash, **$4.9 million** in working capital, an accumulated deficit of **$61.2 million**, and a net loss of **$2.7 million** for the three months ended July 31, 2025[28](index=28&type=chunk) - These factors create substantial doubt about the company's ability to continue as a going concern, necessitating additional funding through public equity, private equity, and debt financings[29](index=29&type=chunk) [3. SIGNIFICANT ACCOUNTING POLICIES](index=9&type=section&id=3.%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - The financial statements are prepared in accordance with U.S. GAAP and SEC rules for smaller reporting companies, with key estimates including stock-based compensation, warrant valuation, and deferred income taxes[30](index=30&type=chunk)[31](index=31&type=chunk) - Research and development costs are expensed as incurred, including scientific consulting fees, clinical trial fees, lab supplies, and upfront/milestone payments for licensed product candidates[37](index=37&type=chunk)[38](index=38&type=chunk) - Stock-based compensation expense is recognized on a straight-line basis using the Black-Scholes option pricing model, with highly subjective assumptions[39](index=39&type=chunk)[41](index=41&type=chunk) - Warrants are accounted for as equity instruments and valued using the Black-Scholes model (Level 3 fair value measurement)[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - The company operates as a single operating and reportable segment, focusing on biopharmaceutical development for neurological and psychiatric disorders[48](index=48&type=chunk) Anti-dilutive Securities Summary | Instrument | For the Three Months Ended July 31, 2025 | For the Three Months Ended July 31, 2024 | | :-------------------- | :------------------------------------- | :------------------------------------- | | Stock options | 12,854 | 12,998 | | Restricted stock units | - | 18 | | Warrants | 137,051 | 48,764 | | Total Anti-dilutive Securities | 149,905 | 61,780 | [4. PREPAID EXPENSES AND OTHER CURRENT ASSETS](index=12&type=section&id=4.%20PREPAID%20EXPENSES%20AND%20OTHER%20CURRENT%20ASSETS) Prepaid Expenses and Other Current Assets Breakdown | Category | July 31, 2025 ($) | April 30, 2025 ($) | | :-------------------------- | :------------ | :------------- | | Prepaid clinical trial expenses | $92,370 | $178,922 | | Prepaid insurance | $202,375 | $42,584 | | Other prepaid expenses | $13,213 | $7,213 | | Total prepaid expenses and other current assets | $307,958 | $228,719 | - Prepaid clinical trial expenses at July 31, 2025, represent the unamortized portion to be amortized over the next six months[51](index=51&type=chunk) - Prepaid insurance at July 31, 2025, primarily consists of the unamortized portion of a $220,000 directors' and officers' insurance policy purchased on June 14, 2025[52](index=52&type=chunk) [5. STOCK-BASED COMPENSATION](index=12&type=section&id=5.%20STOCK-BASED%20COMPENSATION) - The company has two stock incentive plans: the 2016 Stock Incentive Plan (**9,259 shares**, later increased by **5,556 shares**) and the 2021 Stock Incentive Plan (**7,407 shares**)[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) - Stock options are granted at fair value and valued using the Black-Scholes model, with assumptions based on historical volatility of similar companies due to lack of own trading history[57](index=57&type=chunk) Stock Option Activity Summary | Stock Option Activity | Balance at April 30, 2025 | Balance at July 31, 2025 | | :------------------------------------ | :------------------------ | :----------------------- | | Number of Shares Outstanding | 9,406 | 9,406 | | Weighted Average Exercise Price | $1,802.18 | $1,802.18 | | Weighted Average Remaining Contractual Life (years) | 4.80 | 4.55 | | Options Exercisable at Period End | 8,624 | 8,624 | | Weighted Average Exercise Price (Exercisable) | $1,820.61 | $1,820.61 | - Performance-contingent stock options granted in November 2019 (**3,148 awards**) and November 2022 (**1,481 awards**) have specific market or clinical trial milestones for vesting. As of July 31, 2025, the achievement of certain performance conditions for these awards is not considered probable, and no compensation cost has been recognized[59](index=59&type=chunk)[61](index=61&type=chunk)[62](index=62&type=chunk) Stock-Based Compensation Expense | Expense Category | For the Three Months Ended July 31, 2025 ($) | For the Three Months Ended July 31, 2024 ($) | | :------------------------ | :------------------------------------- | :------------------------------------- | | General and administrative | $42,902 | $81,277 | - As of July 31, 2025, total unamortized stock-based compensation expense was **$47,000**, to be recognized over approximately **0.4 years**[63](index=63&type=chunk) [6. WARRANTS](index=15&type=section&id=6.%20WARRANTS) - There was no warrant activity for the three months ended July 31, 2025[64](index=64&type=chunk) Warrant Activity Summary | Exercise Price Range | Number Outstanding | Weighted Average Remaining Contractual Life (years) | Weighted Average Exercise Price (Outstanding) | Number Exercisable | Weighted Average Exercise Price (Exercisable) | | :------------------- | :----------------- | :-------------------------------------------------- | :------------------------------------------ | :----------------- | :------------------------------------------ | | $8.29 - $8,437.50 | 137,051 | 4.4 | $103.56 | 137,051 | $103.56 | [7. COMMITMENTS AND CONTINGENCIES](index=16&type=section&id=7.%20COMMITMENTS%20AND%20CONTINGENCIES) - The company has exclusive worldwide license agreements with the University of South Florida Research Foundation for AL001 and ALZN002 technologies[66](index=66&type=chunk)[68](index=68&type=chunk) - AL001 License Agreements require **4.5% royalty** on net sales and minimum royalties starting at **$40,000** on the first anniversary of commercial sale[67](index=67&type=chunk) - ALZN002 License Agreement requires **4% royalty** on net sales and minimum royalties starting at **$20,000** on the first anniversary of commercial sale[69](index=69&type=chunk) - Additional AL001 Licenses for neurodegenerative and psychiatric diseases require **3% royalty** on net sales and minimum royalties starting at **$40,000**[70](index=70&type=chunk)[71](index=71&type=chunk) **Original AL001 Licenses Milestone Payments:** | Payment | Due Date | | :------------ | :------------------------------------------------ | | **$1,250,000** | Upon first patient treated in a Phase III clinical trial | | **$10,000,000** | Upon FDA NDA approval | **ALZN002 License Milestone Payments:** | Payment | Due Date | | :------------ | :------------------------------------------------ | | **$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 | **Additional AL001 Licenses Milestone Payments:** | Payment | Due Date | | :------------ | :------------------------------------------------ | | **$2,000,000** | Upon first patient treated in a Phase III clinical trial | | **$16,000,000** | First commercial sale | - License agreements have indefinite terms and may be terminated if the company fails to meet specified milestones[147](index=147&type=chunk) [8. EQUITY TRANSACTIONS](index=17&type=section&id=8.%20EQUITY%20TRANSACTIONS) - The company is authorized to issue **10,000,000 shares** of Preferred Stock, with **6,000 designated** as Series B Convertible Preferred Stock and **1,000 as Series C** Convertible Preferred Stock[76](index=76&type=chunk) - Series A Convertible Preferred Stock was eliminated on July 9, 2025[77](index=77&type=chunk) - Series B Convertible Preferred Stock has a stated value of **$1,000 per share**, no dividends, and is convertible into common stock at a **$90.00 conversion price** (subject to adjustment)[81](index=81&type=chunk) - During the three months ended July 31, 2025, **564.75528 shares of Series B Preferred Stock** were converted into **243,429 shares of Common Stock**[83](index=83&type=chunk) - Series C Convertible Preferred Stock has a stated value of **$10,000 per share**, accrues **15% annual dividends**, and is convertible into common stock based on a variable conversion price (minimum **$0.90**, maximum **$135.00**, or **80%** of lowest closing price)[89](index=89&type=chunk) - During the three months ended July 31, 2025, **575.7176 shares of Series C Preferred Stock** were converted into **2,117,699 shares of Common Stock**[90](index=90&type=chunk) - The company completed the sale of all Series C Convertible Preferred Stock under the Orchid SPEA by June 13, 2025, raising approximately **$4.0 million**[85](index=85&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) [9. SUBSEQUENT EVENTS](index=19&type=section&id=9.%20SUBSEQUENT%20EVENTS) - Management has evaluated subsequent events through the date the financial statements were issued and determined there are no events warranting disclosure or recognition[91](index=91&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's analysis of Alzamend Neuro's Q1 2025 financial condition, results, accounting policies, and liquidity [Overview](index=20&type=section&id=Overview) - Alzamend Neuro, Inc. was incorporated on February 26, 2016, to acquire and commercialize patented intellectual property for Alzheimer's disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD)[98](index=98&type=chunk) - The company's two product candidates are AL001 (an ionic cocrystal of lithium) and ALZN002 (a cell-based therapeutic vaccine), with a novel immunotherapy approach to combat Alzheimer's[98](index=98&type=chunk) [Critical Accounting Policies and Estimates](index=20&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) - Stock-based compensation is a critical accounting policy, with costs estimated using the Black-Scholes option pricing model, which relies on subjective assumptions like risk-free interest rate, expected volatility, expected term, and expected dividend yield[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) - Preferred stock classification is determined using ASC 480, considering redemption provisions, conversion options, dividends, voting rights, and collateral requirements[103](index=103&type=chunk) [Plan of Operations](index=21&type=section&id=Plan%20of%20Operations) - The company aims to develop and commercialize therapeutics and vaccines for Alzheimer's, BD, MDD, and PTSD, focusing on advancing clinical development of AL001 and ALZN002, expanding its pipeline, and optimizing product value[104](index=104&type=chunk)[108](index=108&type=chunk) - AL001, an ionic cocrystal of lithium, completed a Phase IIA clinical trial in March 2023 with positive topline data announced in June 2023, identifying a maximum tolerated dose (MTD) designed to avoid therapeutic drug monitoring[105](index=105&type=chunk)[106](index=106&type=chunk) - Preclinical studies showed AL001 resulted in lower plasma lithium levels and consistently higher lithium concentrations in brain tissues compared to lithium carbonate, suggesting an enhanced safety profile and potential for lower doses[111](index=111&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk) - The company initiated five 'Lithium in Brain' Phase II clinical trials for AL001 in May 2025, in collaboration with Massachusetts General Hospital, to compare lithium levels in the brain for healthy subjects and patients with Alzheimer's, BD, MDD, and PTSD[110](index=110&type=chunk)[114](index=114&type=chunk) - ALZN002, an immunotherapy vaccine for Alzheimer's, received a 'study may proceed' letter for its IND application in October 2022, and a Phase I/IIA clinical trial was initiated in April 2023 to assess safety, tolerability, and efficacy[115](index=115&type=chunk)[116](index=116&type=chunk) - The ALZN002 clinical trial faced a setback with the termination of the CRO contract in February 2024, and the company is currently seeking a replacement CRO[116](index=116&type=chunk) - The continuation of current operations and clinical trials requires raising additional capital, as working capital requirements depend on various factors including clinical progress and regulatory approvals[117](index=117&type=chunk)[118](index=118&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Results of Operations Summary | Metric | For the Three Months Ended July 31, 2025 ($) | For the Three Months Ended July 31, 2024 ($) | $ Change ($) | % Change | | :-------------------------- | :------------------------------------- | :------------------------------------- | :------- | :------- | | Research and development | $1,740,867 | $206,571 | $1,534,296 | 743% | | General and administrative | $959,334 | $755,834 | $203,500 | 27% | | Total operating expenses | $2,700,201 | $962,405 | $1,737,796 | 181% | | Loss from operations | $(2,700,201) | $(962,405) | $(1,737,796) | 181% | | Interest expense | $(2,483) | $(12,006) | $9,523 | -79% | | NET LOSS | $(2,702,684) | $(974,411) | $(1,728,273) | 177% | | Basic and diluted net loss per common share | $(1.28) | $(11.42) | $10.14 | * | | Weighted average common shares outstanding | 2,106,036 | 85,314 | | * | - The company did not generate any revenue during the three months ended July 31, 2025 and 2024, and does not anticipate revenue in the foreseeable future[120](index=120&type=chunk) - Research and development expenses increased by **743%** to **$1.7 million** in Q1 2025, primarily due to **$1.7 million** in clinical trial fees for the Phase IIA brain imaging study with Massachusetts General Hospital[121](index=121&type=chunk)[123](index=123&type=chunk) - General and administrative expenses increased by **27%** to **$959,000** in Q1 2025, mainly driven by higher professional fees (legal, audit, tax preparation) and marketing fees, partially offset by lower investor relations fees and stock-based compensation[125](index=125&type=chunk)[126](index=126&type=chunk)[128](index=128&type=chunk)[130](index=130&type=chunk) - The increase in legal fees was a significant factor, resulting from actions related to the termination of the ALZN002 clinical trial[128](index=128&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) - The company's recurring net losses and insufficient cash flows from operations raise substantial doubt about its ability to continue as a going concern for at least one year[131](index=131&type=chunk)[132](index=132&type=chunk) - As of July 31, 2025, the company had **$5.6 million** in cash, **$4.9 million** in working capital, and an accumulated deficit of **$61.2 million**[132](index=132&type=chunk) - Future operations and clinical development activities will require substantial additional funding, primarily through equity sales and potentially debt financing[132](index=132&type=chunk)[133](index=133&type=chunk) Cash Flow Summary | Cash Flow Activity | For the Three Months Ended July 31, 2025 ($) | For the Three Months Ended July 31, 2024 ($) | | :----------------------------------- | :------------------------------------- | :------------------------------------- | | Net cash used in operating activities | $(2,362,786) | $(1,055,742) | | Net cash used in investing activities | $- | $(90,000) | | Net cash provided by financing activities | $4,035,000 | $1,963,644 | | Net increase in cash and cash equivalents | $1,672,214 | $817,902 | - Net cash used in operating activities was **$2.4 million** for Q1 2025, primarily due to a net loss of $2.7 million, partially offset by non-cash charges and changes in operating assets/liabilities[137](index=137&type=chunk) - Net cash provided by financing activities was **$4.0 million** for Q1 2025, entirely from the sale of Series C Convertible Preferred Stock[139](index=139&type=chunk) [Contractual Obligations](index=26&type=section&id=Contractual%20Obligations) - The company has exclusive license agreements for AL001 and ALZN002, requiring royalty payments on net sales (**4.5% royalty** for AL001, **4% royalty** for ALZN002, **3% royalty** for additional AL001 indications) and minimum annual royalties after commercial sale[140](index=140&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk)[144](index=144&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk) **Original AL001 Licenses Milestone Payments:** | Payment | Due Date | | :------------ | :------------------------------------------------ | | **$1,250,000** | Upon first patient treated in a Phase III clinical trial | | **$10,000,000** | Upon FDA NDA approval | **ALZN002 License Milestone Payments:** | Payment | Due Date | | :------------ | :------------------------------------------------ | | **$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 | **Additional AL001 Licenses Milestone Payments:** | Payment | Due Date | | :------------ | :------------------------------------------------ | | **$2,000,000** | Upon first patient treated in a Phase III clinical trial | | **$16,000,000** | First commercial sale | - License agreements have indefinite terms and may be terminated if the company fails to meet specified milestones[147](index=147&type=chunk) [Recent Accounting Standards](index=28&type=section&id=Recent%20Accounting%20Standards) - There are no recent accounting standards to disclose[152](index=152&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable to Alzamend Neuro, Inc. because it is a smaller reporting company - This section is not applicable as the company is a smaller reporting company[153](index=153&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management found disclosure controls ineffective as of July 31, 2025, due to accounting resource gaps; remediation is planned - The principal executive officer and principal financial officer concluded that the company's internal control over financial reporting was not effective as of July 31, 2025[155](index=155&type=chunk) - A material weakness was identified: insufficient resources in the accounting department, restricting the ability to perform sufficient reviews of manual journal entries, account reconciliations, financial statement preparation, and non-routine transactions[156](index=156&type=chunk) - Planned remediation measures include formalizing internal control documentation and strengthening supervisory reviews by management, with a future need to increase accounting department staff[157](index=157&type=chunk)[158](index=158&type=chunk) - Despite the control deficiency, management believes the condensed financial statements fairly present the company's financial condition, results of operations, and cash flows[159](index=159&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) Alzamend Neuro is not party to legal proceedings expected to materially affect its business or financials - The company is not currently a party to or aware of any legal proceedings that are believed to have a material adverse effect on its business, financial condition, or results of operations[162](index=162&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) Refer to the 2025 Annual Report on Form 10-K for current risk factors that may materially affect the business - The risks described in Part I, Item 1A, 'Risk Factors,' in the company's 2025 Annual Report on Form 10-K remain current in all material respects and could materially and adversely affect the business[163](index=163&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period - No unregistered sales of equity securities and use of proceeds to report[164](index=164&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report for the period - No defaults upon senior securities to report[165](index=165&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[166](index=166&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading arrangements were adopted, modified, or terminated by D&Os in Q1 2025 - 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 fiscal quarter ended July 31, 2025[167](index=167&type=chunk) [Item 6. Exhibits](index=30&type=section&id=Item%206.%20Exhibits) Lists all Form 10-Q exhibits, including certificates, bylaws, and SEC-required certifications - The exhibits include Certificate of Incorporation, Amended and Restated Bylaws, and certifications from the Chief Executive Officer and Chief Financial Officer[168](index=168&type=chunk)[169](index=169&type=chunk) [Signatures](index=32&type=section&id=Signatures) Alzamend Neuro's CEO and CFO signed the report on September 10, 2025 - The report is signed by Stephan Jackman, Chief Executive Officer, and David J. Katzoff, Chief Financial Officer, on September 10, 2025[174](index=174&type=chunk)

Core Viewpoint - Alzamend Neuro, Inc. is set to present its innovative research on AL001, a novel lithium-delivery system, at the Military Health System Research Symposium, highlighting its potential benefits for treating PTSD and other mental health disorders in military personnel and veterans [1][2]. Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [9]. - The company’s pipeline includes two main drug candidates: AL001, a patented ionic cocrystal technology for lithium delivery, and ALZN002, a cell-based therapeutic vaccine aimed at combating Alzheimer's [9]. Research Presentation Details - The poster presentation titled "Quantitate Differences in Lithium Brain-to-Plasma Exposure in PTSD Subjects Between AL001 and Lithium Carbonate" will take place on August 6, 2025, at the Gaylord Palms Resort & Convention Center [4][5]. - The session will focus on innovations in military suicide prevention and related research [5]. Study Objectives - The study aims to quantify differences in lithium exposure in the brain versus plasma in PTSD subjects, comparing AL001 with traditional lithium carbonate [6]. - This research is part of a broader effort to create a composite database that includes data from various neurodegenerative and neuropsychiatric disorders [6]. AL001 Characteristics - AL001 is designed to provide the benefits of lithium while minimizing toxicities associated with conventional lithium salts, potentially improving safety and efficacy [7]. - Results from a completed Phase IIA study indicated a maximum tolerated dose that does not require therapeutic drug monitoring, suggesting a favorable safety profile [7]. Clinical Trials - Alzamend initiated the first of five Phase II clinical studies of AL001 in May 2025, focusing on healthy human subjects to establish baseline data for future studies in patients with Alzheimer's, BD, MDD, and PTSD [8]. - Previous animal studies indicated that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, which could lead to safer treatments [8].

[Form 8-K Filing Information](index=1&type=section&id=Form%208-K%20Filing%20Information) This section details the registrant's official information, securities listing, and emerging growth company status for the Form 8-K filing [Registrant Details](index=1&type=section&id=Registrant%20Details) This section provides the official details of Alzamend Neuro, Inc. as the registrant for this Form 8-K filing, including its incorporation state, commission file number, and principal executive offices - Registrant: **Alzamend Neuro, Inc.**[2](index=2&type=chunk) - State of Incorporation: **Delaware**[2](index=2&type=chunk) - Commission File Number: **001-40483**[2](index=2&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) The company's common stock is listed on The Nasdaq Capital Market under the symbol ALZN Securities Registered Pursuant to Section 12(b) of the Act | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :-------------------------- | :---------------- | :---------------------------------------- | | Common Stock, $0.0001 par value | ALZN | The Nasdaq Capital Market | [Emerging Growth Company Status](index=1&type=section&id=Emerging%20Growth%20Company%20Status) Alzamend Neuro, Inc. identifies itself as an 'emerging growth company' but has not elected to use the extended transition period for complying with new or revised financial accounting standards - The registrant is an **'emerging growth company'**[4](index=4&type=chunk) - The registrant has elected not to use the extended transition period for complying with new or revised financial accounting standards[4](index=4&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This section covers the announcement of financial results, associated legal disclaimers, and forward-looking statements [Financial Results Announcement](index=2&type=section&id=Financial%20Results%20Announcement) Alzamend Neuro, Inc. announced its audited financial results for the year ended April 30, 2025, via a press release issued on July 23, 2025, which is attached as Exhibit 99.1 to this Form 8-K - Alzamend Neuro, Inc. issued a press release on **July 23, 2025**, announcing audited financial results for the year ended **April 30, 2025**[5](index=5&type=chunk) - The press release is attached as **Exhibit 99.1** and incorporated by reference[5](index=5&type=chunk) [Legal Disclaimers](index=2&type=section&id=Legal%20Disclaimers) The information provided in Item 2.02 and Exhibit 99.1 is not considered 'filed' for certain sections of the Securities Exchange Act of 1934 or the Securities Act of 1933, limiting its liability and incorporation by reference into other SEC filings unless explicitly stated - Information in Item 2.02 and Exhibit 99.1 is not deemed **'filed'** for purposes of Section 18 of the Securities Exchange Act of 1934 or Sections 11 and 12(a)(2) of the Securities Act of 1933[6](index=6&type=chunk) - This information shall not be incorporated by reference into other SEC filings unless expressly set forth by specific reference[6](index=6&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) The report includes forward-looking statements, which are subject to inherent uncertainties and risks that could cause actual results to differ materially from expectations, and investors are cautioned against undue reliance on them - This Current Report on Form 8-K and its exhibits may contain **'forward-looking statements'** as defined by the Private Securities Litigation Reform Act of 1995[7](index=7&type=chunk) - These statements involve risks and uncertainties that could cause actual results to differ materially from anticipated outcomes[7](index=7&type=chunk) - Investors are cautioned not to rely unduly on forward-looking statements[7](index=7&type=chunk) [Additional Information and Exhibits](index=2&type=section&id=Additional%20Information%20and%20Exhibits) This section directs readers to where they can find additional SEC filings and lists all exhibits furnished with the Form 8-K [Where to Find Additional Information](index=2&type=section&id=Where%20to%20Find%20Additional%20Information) Investors can access additional documents filed by Alzamend Neuro, Inc. with the Securities and Exchange Commission (SEC) free of charge through the SEC's website or at its public reference room - Documents filed with the SEC are available free of charge at **www.sec.gov**[9](index=9&type=chunk) - Reports and other information can also be read and copied at the SEC public reference room in Washington D.C.[9](index=9&type=chunk) [Item 9.01 Financial Statements And Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20And%20Exhibits) This section lists the exhibits furnished with the Form 8-K, including the press release announcing financial results and XBRL-related documents for electronic filing Exhibits Furnished with Form 8-K | Exhibit No. | Description | | :---------- | :------------------------------------------------------------------------------------------------------ | | 99.1 | Press Release issued on July 23, 2025 | | 101 | Pursuant to Rule 406 of Regulation S-T, the cover page is formatted in Inline XBRL (Inline eXtensible Business Reporting Language) | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101) | [Signature](index=3&type=section&id=Signature) This section certifies the report's submission on behalf of Alzamend Neuro, Inc. by its Chief Financial Officer [Report Certification](index=3&type=section&id=Report%20Certification) The report is duly signed on behalf of Alzamend Neuro, Inc. by its Chief Financial Officer, David J. Katzoff, certifying compliance with the Securities Exchange Act of 1934 - The report was signed on **July 23, 2025**[14](index=14&type=chunk) - Signed by **David J. Katzoff**, Chief Financial Officer of Alzamend Neuro, Inc.[14](index=14&type=chunk)

Core Insights - Alzamend Neuro, Inc. reported financial results for the year ended April 30, 2025, highlighting a strengthened financial position and strategic focus on fiscal prudence and effective capital management [1][2] - The company successfully completed a $5 million financing ahead of schedule, which will support five Phase II clinical trials of its drug candidate AL001 in partnership with Massachusetts General Hospital and Harvard Medical School [3][4] Financial Performance - For the year ended April 30, 2025, net cash provided by financing activities was $10.4 million, with stockholder equity increasing to $4.0 million from a deficit of $2.6 million the previous year [6] - Cash reserves improved significantly to $3.9 million at April 30, 2025, compared to $0.4 million at April 30, 2024, while total liabilities decreased to $0.6 million from $3.2 million [6] Clinical Advancements - Alzamend is advancing treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, primarily through its drug candidate AL001, which aims for safer and more effective lithium therapy [3][4] - The first of five Phase II clinical trials for AL001 began in May 2025, with topline results expected by the end of 2025 [4] Product Pipeline - The company is developing two therapeutic drug candidates: AL001, a lithium-salicylate/L-proline cocrystal, and ALZN002, an active immunotherapy product targeting amyloid-beta proteins [5][10] - ALZN002 is currently in a Phase I/IIA clinical trial to evaluate its safety and efficacy in patients with mild to moderate Alzheimer's [8]

Financial Position and Capital Needs - As of April 30, 2025, the company had $3.9 million in cash and cash equivalents, and raised an additional $4.0 million in February 2025, but this funding is insufficient to support operations for the next twelve months [161]. - The company must raise substantial additional capital to complete the development and commercialization of AL001 and ALZN002, which may involve significant dilution for existing shareholders [161]. - The independent registered public accounting firm has expressed substantial doubt about the company's ability to continue as a going concern due to insufficient capital [164]. Product Development and Regulatory Approval - The company has two product candidates, AL001 and ALZN002, which require extensive clinical evaluation and regulatory approval before generating any revenue [166]. - The company has not yet submitted AL001 or ALZN002 for regulatory approval, which is necessary before commercial distribution can begin [180]. - The regulatory approval process for AL001 and ALZN002 is uncertain and resource-intensive, potentially delaying commercialization [202]. - The company plans to seek breakthrough therapy designation for both AL001 and ALZN002, which may provide additional guidance from the FDA during the development process [215]. - The company has not yet received breakthrough therapy designation or qualified for expedited development, which could extend the development timeline [216]. Market Risks and Competition - The company faces substantial competition, which may impact pricing and market acceptance of its products [188]. - If competitors develop safer, more effective, or less expensive products, the company's commercial opportunity could be significantly reduced [236]. - The high rate of failure for drug candidates in clinical trials poses a significant risk to the company's product development [206]. Financial Reporting and Internal Controls - The company has identified a material weakness in its internal control over financial reporting, which could lead to inaccurate financial statements and affect investor confidence [290]. - The company must enhance its accounting department to address identified weaknesses, which will require time and financial resources [292]. - The company is required to comply with the Sarbanes-Oxley Act and maintain effective internal controls over financial reporting, which is a complex and costly process [303]. Legal and Compliance Risks - The company may face significant penalties if found in violation of fraud and abuse laws, which could adversely affect its business [228]. - The company is subject to various legal claims and actions that could be costly and distract management from operations [298]. - The company’s bylaws may limit stockholders' ability to bring claims in favorable judicial forums, potentially discouraging lawsuits [283]. Stock and Ownership Structure - The common stock is subject to volatility, with prices fluctuating between $5.94 and $66.15 per share over the past year [275]. - The concentration of stock ownership among executive officers and directors may limit the ability of other stockholders to influence corporate matters [280]. - The company is currently in compliance with Nasdaq listing requirements, but has faced non-compliance issues in the past year, which could lead to delisting [271]. Operational Challenges - The company expects substantial increases in expenses over the next few years due to the capital-intensive nature of biotechnology product development, particularly for AL001 and ALZN002 [160]. - Clinical trials for AL001 and ALZN002 are expected to be expensive and time-consuming, with potential for delays or cancellations [210]. - The company anticipates challenges in hiring qualified personnel due to intense competition in the biopharmaceutical field [296]. Intellectual Property Risks - The company may need to litigate to protect its intellectual property rights, which could be costly and distract management from core business activities [243]. - There is a risk that trade secrets and proprietary information may be inadequately protected, allowing competitors to develop similar products [245]. - The strength and enforceability of the company's patents may be uncertain, potentially threatening its ability to commercialize products [254].

Core Insights - Alzamend Neuro, Inc. has successfully completed a $5 million private placement to support its clinical trials for various mental health conditions [1][3][5] Financing Details - The financing involved a Securities Purchase & Exchange Agreement with a sophisticated investor, allowing the sale of up to 500 shares of Series C Convertible Preferred Stock and warrants for a total of $5 million, with a 5% discount [2] - The investor purchased the remaining shares of Preferred Stock ahead of the final tranche closing originally scheduled for October 2025, significantly enhancing Alzamend's financial position [3] Clinical Trials - The capital raised will fund five Phase II clinical trials of AL001 "Lithium in Brain" Studies at Massachusetts General Hospital, with the first trial initiated in May 2025 and topline data expected by the end of 2025 [4] - The second trial for bipolar disorder is set to begin in Q3 2025, while the remaining trials for Alzheimer's, major depressive disorder, and PTSD are expected to commence in Q4 2025 [4] Company Overview - Alzamend Neuro focuses on developing novel treatments for Alzheimer's, bipolar disorder, major depressive disorder, and PTSD, with a pipeline that includes two therapeutic drug candidates: AL001 and ALZN002 [6] - AL001 utilizes patented ionic cocrystal technology to deliver lithium, while ALZN002 aims to restore the immune system's ability to combat Alzheimer's by removing beta-amyloid from the brain [6]

Core Viewpoint - Alzamend Neuro, Inc. has initiated its first Phase II clinical study of AL001, a novel lithium-delivery system aimed at treating Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder, with the first patient dosed in the trial [1][4]. Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [6]. - The company's pipeline includes two therapeutic candidates: AL001, which utilizes patented ionic cocrystal technology for lithium delivery, and ALZN002, a cell-based therapeutic vaccine targeting Alzheimer's [6]. Product Details - AL001 is designed to enhance lithium delivery to the brain while minimizing systemic side effects and the need for therapeutic drug monitoring (TDM) [3][5]. - Previous studies indicated that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, potentially leading to safer treatment options [2][5]. - The formulation aims to reduce the risks associated with traditional lithium therapies, such as kidney and thyroid side effects, by favorably distributing lithium in the brain [3][5]. Clinical Study Insights - The Phase II study will assess AL001's effectiveness in healthy subjects, serving as a baseline for future studies in patients with Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [2][4]. - Topline data from the study is expected to be announced before the end of 2025 [4][9]. - Head-to-head studies comparing AL001 with marketed lithium carbonate products will be conducted to evaluate pharmacokinetics in healthy subjects [9].

Core Insights - Alzamend Neuro, Inc. has initiated its first Phase II clinical study of AL001, targeting conditions such as Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [1][4] - The study aims to evaluate AL001's ability to deliver lithium more effectively in the brain compared to existing lithium salts, with a focus on safety and reduced side effects [2][5] Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [6] - The company's pipeline includes two main candidates: AL001, a lithium-delivery system, and ALZN002, a cell-based therapeutic vaccine targeting Alzheimer's [6] Product Details - AL001 is designed to provide the benefits of lithium while minimizing toxicities associated with traditional lithium therapies, potentially eliminating the need for therapeutic drug monitoring [3][5] - Previous studies indicate that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, which could lead to safer treatment options [2][5] Clinical Study Insights - The Phase II study will involve healthy human subjects to establish a baseline for AL001's effectiveness and safety profile [2][4] - Topline data from the study is expected by the end of the year, with plans for head-to-head comparisons against marketed lithium carbonate products [4][9]

Core Insights - Alzamend Neuro, Inc. has initiated the first of five Phase II clinical studies for AL001, targeting conditions such as Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [1][2] - The study aims to demonstrate AL001's effectiveness in delivering lithium more efficiently to the brain while reducing systemic side effects compared to traditional lithium salts [2][3] Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [6] - The company's pipeline includes two main candidates: AL001, a novel lithium-delivery system, and ALZN002, a cell-based therapeutic vaccine aimed at combating Alzheimer's [6][8] Product Details - AL001 is designed to provide the benefits of marketed lithium salts while minimizing toxicities, potentially eliminating the need for therapeutic drug monitoring [5][3] - Previous studies indicate that AL001 allows for better brain absorption of lithium while maintaining lower blood levels, which could lead to safer treatment options [2][5] Market Potential - The introduction of AL001 could significantly enhance treatment outcomes for over 43 million Americans suffering from the targeted conditions, potentially reshaping current treatment paradigms [4][3] - By addressing the complexities associated with traditional lithium therapies, AL001 may improve patient quality of life and adherence to treatment [3][4] Future Developments - Topline data from the ongoing studies is expected by the end of the year, with head-to-head comparisons planned against a marketed lithium carbonate product [7]

Core Viewpoint - Alzamend Neuro, Inc. has announced a one-for-nine reverse stock split to comply with Nasdaq's minimum bid price requirement and to enhance its market position [1][2]. Company Overview - Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing treatments for Alzheimer's disease, bipolar disorder, major depressive disorder, and post-traumatic stress disorder [4]. - The company is developing two novel therapeutic drug candidates: AL001, which utilizes a patented ionic cocrystal technology for lithium delivery, and ALZN002, a cell-based therapeutic vaccine aimed at combating Alzheimer's by removing beta-amyloid from the brain [4]. Reverse Stock Split Details - The reverse stock split will be effective on May 12, 2025, at 12:01 a.m. Eastern Time, and will adjust the trading of the company's common stock on Nasdaq under the existing symbol "ALZN" [1]. - The number of shares outstanding will decrease from 7,208,591 to approximately 800,954 after the split [2]. - The par value of the common stock will remain unchanged at $0.0001 per share, and no fractional shares will be issued; instead, stockholders entitled to fractional shares will receive cash payments [2][3].