Alzamend Neuro, Inc.

Previous wording

We intend to develop and commercialize therapeutics and vaccines that are better than existing treatments and have the potential to significantly improve the lives of individuals afflicted by Alzheimer’s, BD, MDD and PTSD. To achieve these goals, we are pursuing the following key business strategies:

Current wording

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:

Previous wording

On May 5, 2022, we initiated a multiple-dose, steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic clinical trial of AL001 in patients with mild to moderate Alzheimer’s and healthy subjects. We completed the Phase IIA clinical trial in March 2023 and announced positive topline data in June 2023, followed by the full data set in October 2024.

Current wording

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.

Previous wording

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, 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.

Current wording

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.

Previous wording

Based on the results from our Phase IIA MAD study, we plan to initiate five clinical trials to determine relative increased lithium levels in the brain compared to a marketed lithium salt for healthy subject and patients diagnosed with mild to moderate Alzheimer’s, BD, MDD and PTSD, based on published mouse studies that predict that lithium can be given at lower doses for equivalent therapeutic benefit when treating with AL001. For example, the goal is to replace the amount of lithium needed for maintenance treatment of BD with a clinically relevant, lower AL001 lithium carbonate equivalent lithium dose. Such lithium dose mitigation could redefine the landscape of neuropsychiatric, neurodegenerative, and neurological treatment practices. In August 2024, we announced that we had partnered with Massachusetts General Hospital to serve as the contract research organization (“CRO”) for these clinical trials.

Current wording

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.

Previous wording

On November 19, 2024, we announced a final full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer’s transgenic mice. The study was conducted at the University of South Florida and the bioanalytical procedures for determination of lithium concentration in the brain and plasma samples were conducted under good laboratory practice standards by Sannova Analytical LLC. The study involved administering AL001, a good manufacturing practices-quality active pharmaceutical ingredient (“API”) to 5XFAD mice, a recognized model for Alzheimer’s research, to compare its effects against lithium carbonate, an FDA approved and marketed API. Mice received either high or low doses scaled to humans of both AL001 and lithium carbonate over a 14-day period to observe pharmacokinetic steady-state drug conditions. On the 15th day, the mice were analyzed to assess how the treatments affected lithium concentrations in different brain regions and in their plasma.

Current wording

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.

Previous wording

On September 28, 2022, we submitted an IND application to the FDA for ALZN002 and received a “study may proceed” letter on October 31, 2022. The product candidate is an immunotherapy vaccine designed to treat mild to moderate dementia of the Alzheimer’s type. ALZN002 is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous dendritic cells (“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.

Current wording

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.

Previous wording

On April 3, 2023, we announced the initiation of a Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia of the Alzheimer’s type. The purpose of this trial is to assess the safety, tolerability, and efficacy of multiple ascending doses of ALZN002 compared with that of a placebo in 20-30 subjects with mild to moderate morbidity. The primary goal of this clinical trial is to determine an appropriate dose of ALZN002 for treatment of patients with Alzheimer’s in a larger Phase IIB efficacy and safety clinical trial. On February 13, 2024, we received notice from the company we engaged as CRO, Biorasi, LLC (“Biorasi”) that Biorasi was terminating our contract with them. We are currently pursuing the engagement of a replacement CRO.

Current wording

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.

Previous wording

The continuation of our current plan of operations with respect to initiating and conducting the series of human clinical trials for each of our therapeutics requires us to raise additional capital to fund our operations.

Current wording

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.

Previous wording

We currently have only two product candidates, AL001 and ALZN002. These products are in the clinical stage of development and will require extensive clinical study, review and evaluation, regulatory review and approval, significant marketing efforts and substantial investment before either or both of them, and any respective successors, will provide us with any revenue. We did not generate any revenues during the three months ended January 31, 2026 and 2025, and we do not anticipate that we will generate revenue for the foreseeable future.

Current wording

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.

Previous wording

Research and development expenses for the three months ended January 31, 2026 and 2025 were $1.3 million and $447,000, respectively. As reflected in the table below, research and development expenses primarily consisted of professional fees and clinical trial fees:

Current wording

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:

Previous wording

During the three months ended January 31, 2026 and 2025, we incurred professional fees of $255,000 and $135,000, 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 upcoming clinical trial activities.

Current wording

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.

Previous wording

During the three months ended January 31, 2026 and 2025, we incurred other fees of $7,000 and $14,000, respectively, which were primarily comprised of scientific materials required for our clinical trials.

Current wording

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.

Previous wording

General and administrative expenses for the three months ended January 31, 2026 and 2025 were $919,000 and $590,000, 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 January 31, 2026 and 2025, the remaining general and administrative expenses of $111,000 and $116,000, respectively, primarily consisted of payments for filing fees, transfer agent fees, travel and entertainment and other office expenses, none of which was significant individually.

Current wording

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.

Previous wording

During the three months ended January 31, 2026 and 2025, we incurred salaries and benefits of $310,000 and $227,000, respectively. The increase in salaries and benefits was due mainly to higher bonuses paid. As of January 31, 2026, we had four full-time and two part-time employees.

Current wording

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.

Previous wording

During the nine months ended January 31, 2026 and 2025, we incurred professional fees of $1.0 million and $433,000, respectively. During the nine months ended January 31, 2026, we incurred $818,000 in legal fees, $126,000 in audit fees, $66,000 in investor relation fees, $32,000 in tax preparation fees and $9,000 in consulting fees. During the nine months ended January 31, 2025, we incurred $173,000 in audit fees, $144,000 in legal fees, $92,000 in investor relation fees, $22,000 in tax preparation fees and $2,000 in consulting fees. The increase in professional fees was due mainly to higher legal and tax preparation fees, partially offset by lower audit and investor relations fees. The increase in legal fees, which accounted for a significant proportion of the increase, was a result of litigation against the CRO from the termination of our ALZN002 clinical trial.

Current wording

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.

Previous wording

During the three months ended January 31, 2026 and 2025, we incurred insurance expense of $59,000 and $60,000, respectively, which was primarily directors’ and officers’ insurance.

Current wording

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.

Previous wording

During the three months ended January 31, 2026 and 2025, we incurred general and administrative stock-based compensation expense of $9,000 and $81,000, respectively, related to stock option grants and restricted stock grants to executives, employees and consultants. The decrease in stock-based compensation expense for the three months ended January 31, 2026, was a result of fewer stock options vesting during the period compared to the prior year period.

Current wording

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.

Previous wording

During the three months ended January 31, 2026, we incurred marketing fees of $50,000, related to the marketing and branding of our company. We did not incur any marketing fees for the three months ended January 31, 2025.

Current wording

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.

Previous wording

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 provided 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.

Current wording

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.

Previous wording

Our inability to continue as a going concern could have a negative impact on our company, particularly if we are unable to obtain needed financing. We intend to finance our future development activities and our working capital needs largely through the sale of equity securities with some additional funding from other sources, including debt financing, until such time as funds provided by operations are sufficient to fund working capital requirements. Ourcondensed 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 January 31, 2026, we had cash of $2.7 million, working capital of $1.8 million, stockholders’ equity of $2.2 million and an accumulated deficit of $64.4 million. We incurred recurring losses and reported losses for the three and nine months ended January 31, 2026 totaling $2.2 million and $5.9 million, respectively. In the past, we have financed our operations principally through sales of equity securities and debt instruments.

Current wording

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. Ourcondensed 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.

Previous wording

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:

Current wording

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.

Previous wording

See Note 9 Subsequent Events in the notes to the financial statements for a description of our latest fundraising activities.

Current wording

See Note 8 Equity Transactions in the notes to the financial statements for a description of our latest fundraising activities.

Previous wording

The following table summarizes our cash flows for the nine months ended January 31, 2026 and 2025:

Current wording

The following table summarizes our cash flows for the three months ended July 31, 2026 and 2025:

Previous wording

During the nine months ended January 31, 2026, net cash used in operating activities was $5.3 million. This consisted primarily of a net loss of $5.9 million, partially offset by an increase in our net operating assets and liabilities of $465,000 and by non-cash charges of $167,000. The non-cash charges consisted of stock-based compensation expense and depreciation expense. The increase in our net operating assets and liabilities was due to an increase in accounts payable and accrued liabilities and an increase in prepaid expenses and other current assets.

Current wording

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.

Previous wording

During the nine months ended January 31, 2026, there was no net cash used in investing activities.

Current wording

During the three months ended July 31, 2026, no net cash was used in investing activities.

Previous wording

During the nine months ended January 31, 2026, net cash provided by financing activities was $4.0 million from the sale of Series C Convertible Preferred Stock.

Current wording

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.

Previous wording

See Note 7 Commitments and Contingencies in the notes to the financial statements for a description of our contractual obligations.

Current wording

See Note 7 Commitments and Contingencies in the notes to the condensed financial statements for a description of our contractual obligations.