Alzamend Neuro, Inc.
For the period ended Apr 30, 2025. Filed Jul 22, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Jul 22, 2025
ALZN$1.41-9.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-04-30; filed 2024-07-30.
0001214659-24-013191
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-K
Period ended 2025-04-30; filed 2025-07-22.
0001214659-25-010763
Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 100 previous paragraphs and 99 current paragraphs.
54 unchanged; 31 reworded; 11 added; 15 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 34 previous and 27 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (11)
Current report
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 15 th day, the mice were analyzed to assess how the treatments affected lithium concentrations in different brain regions and in their plasma.
Current report
Based on the study, both treatments had no negative impact on the mice's body weight or clinical signs during the treatment period. AL001 showed lower plasma lithium levels than lithium carbonate, reducing the risk of adverse systemic effects, suggesting an expansion for safety of lithium’s therapeutic index. Further, AL001 showed consistently higher lithium concentrations in brain tissues, particularly at lower doses, compared to lithium carbonate. Finally, the study found that different brain regions absorb and retain lithium differently. This means treatments can potentially be tailored to target specific brain areas, allowing for more precise treatment of various brain-related conditions when applied in human studies.
Current report
These results highlight the potential clinical advantages of AL001 for conditions like Alzheimer’s, BD, MDD and PTSD at low doses. By reducing the systemic burden, AL001 could lessen the risk of side effects such as thyroid and kidney complications often associated with extant lithium therapies. This positions AL001 as a promising candidate for safer long-term treatment options, without the need for TDM. This innovation is specifically designed to address the needs of fragile populations, such as elderly and Alzheimer’s patients, by offering a potentially more efficient and safer alternative to existing treatments.
Current report
The dosing level identified as optimal in this robust nonclinical study will serve as the foundation for advancing the evaluation of AL001 in the comprehensive ‘Lithium in Brain’ Phase II clinical trials. These trials, conducted in collaboration with Massachusetts General Hospital, will encompass a diverse cohort of both healthy subjects and patients diagnosed with mild to moderate Alzheimer’s disease, BD, MDD and PTSD. In May 2025, we began the trial and dosed the first healthy subject.
Current report
During the year ended April 30, 2025, Orchid converted 712.0133 shares of Series A Convertible Preferred Stock into 420,809 shares of Common Stock.
Current report
On February 28, 2025, we and Orchid terminated the Orchid SPA and entered into the Securities Purchase and Exchange Agreement (the “Orchid SPEA”). With the termination, 97.7511 shares of Series A Convertible Preferred Stock were converted to 97.7511 shares of Series C Convertible Preferred Stock and warrants to purchase 71,111 shares of common stock with an exercise price of $112.50 issued were cancelled.
Current report
Series C Preferred Financing
Current report
On February 28, 2025, we and Orchid entered into the Orchid SPEA for the purchase of up to 500 shares of Series C Convertible Preferred Stock in several tranche closings and warrants to purchase shares up to 111,111 shares of Common Stock with an exercise price of $8.29 (the “Series CExercise Price”) and are exercisable upon issuance and have a five-year term, expiring on the fifth anniversary of issuance. The Series CExercise Price is subject to adjustment in the event of an issuance of Common Stock at a price per share lower than the Series CExercise Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. In addition, 97.7511 shares of Series A Convertible Preferred Stock were converted to 97.7511 shares of Series C Convertible Preferred Stock.
Current report
Between April 28, 2025 and June 13, 2025, we sold an aggregate of 500 shares of Series C Convertible Preferred Stock for an aggregate purchase price of $5 million. Effective June 13, 2025, the Orchid SPEA was terminated as all the shares of Series C Convertible Preferred Stock were sold.
Current report
During the year ended April 30, 2025, Orchid converted 23.9712 shares of Series C Convertible Preferred Stock into 44,444 shares of Common Stock. From May 1, 2025 to July 22, 2025, subsequent to our fiscal year end, Orchid converted 575.7176 shares of Series C Convertible Preferred Stock into 2,117,699 shares of Common Stock.
Current report
See the “Intellectual Property and Licensing Agreements” sub-section under Item 1. Business of this Annual Report.
Removed paragraphs (15)
Previous report
**Research and Development Expenses.**Research and development costs are expensed as incurred. Research and development costs consist of scientific consulting fees and lab supplies, as well as fees paid to other entities that conduct certain research and development activities on behalf of our company.
Previous report
We have acquired and may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire license, product or rights, as well as any future milestone payments, are immediately recognized as research and development expense provided that there is no alternative future use of the rights in other research and development projects.
Previous report
For the period ended January 31, 2024, we recorded the Series B Convertible Preferred Stock as mezzanine equity and the warrant as a liability. On March 21, 2024, we amended our Amended and Restated Certificate of Designations for our Series B Convertible Preferred Stock to remove certain change of control language that could be interpreted to require either debt or equity classification of the Series B Convertible Preferred Stock. As a result, we classified both the Series B Convertible Preferred Stock and warrant as equity for the period ended April 30, 2024.
Previous report
Pursuant to the Orchid SPA, Orchid has agreed to purchase the remaining 2,250 Preferred Shares based on our achievement of the milestones set forth below (the “Milestones”):
Previous report
On July 2, 2018, we entered into two Standard Exclusive License Agreements with Sublicensing Terms for AL001 with the Licensor and its affiliate, the University of South Florida (the “AL001 Licenses”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses limited to the field of Alzheimer’s, under 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, we entered into the First Amendments to the AL001 Licenses, on March 30, 2021, we entered into the Second Amendments to the AL001 Licenses and on June 8, 2023, we entered into the Third Amendments to the AL001 Licenses (collectively, the “AL001 License Agreements”). The Third Amendments to the AL001 Licenses modified the timing of the payments for the license fees.
Previous report
The AL001 License Agreements require that we pay combined royalty payments of 4.5% on net sales of products developed from the licensed technology for AL001. We have already paid an initial license fee of $200,000 for AL001. As an additional licensing fee for the license of the AL001 technologies, the Licensor received 14,853 shares of our common stock. Minimum royalties for AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every year thereafter, for the life of the AL001 License Agreements.
Previous report
On May 1, 2016, we entered into a Standard Exclusive License Agreement with Sublicensing Terms for ALZN002 with the Licensor (the “ALZN002 License”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide license limited to the field of Alzheimer’s Immunotherapy and Diagnostics, under 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, we entered into the First Amendment to the ALZN002 License, on May 7, 2018, we entered into the Second Amendment to the ALZN002 License, on January 31, 2019, we entered into the Third Amendment to the ALZN002 License, on January 24, 2020, we entered into the Fourth Amendment to the ALZN002 License, on March 30, 2021, we entered into the Fifth Amendment to the ALZN002 License, on April 17, 2023, we entered into the Sixth Amendment to the ALZN002 License and on December 11, 2023, we entered into the Seventh Amendment to the ALZN002 License (collectively, the “ALZN002 License Agreement”). The Seventh Amendment to the ALZN002 License modified the timing of the payments for the license fees.
Previous report
The ALZN002 License Agreement requires us to pay royalty payments of 4% on net sales of products developed from the licensed technology for ALZN002. We have already paid an initial license fee of $200,000 for ALZN002. As an additional licensing fee for the license of ALZN002, the Licensor received 24,012 shares of our common stock. Minimum royalties for ALZN002 are $20,000 on the first anniversary of the first commercial sale, $40,000 on the second anniversary of the first commercial sale and $50,000 on the third anniversary of the first commercial sale and every year thereafter, for the life of the ALZN002 License Agreement.
Previous report
On November 19, 2019, we entered into two Standard Exclusive License Agreements with Sublicensing Terms for two additional indications of AL001 with the Licensor (the “November AL001 License”), pursuant to which the Licensor granted us a royalty bearing exclusive worldwide licenses limited to the fields of (i) neurodegenerative diseases excluding Alzheimer’s and (ii) psychiatric diseases and disorders. On March 30, 2021, we entered into the First Amendments to the November AL001 License and on April 17, 2023, we entered into the Second Amendments to the November AL001 License (collectively, the “November AL001 License Agreements”). The Second Amendments to the November AL001 License modified the timing of the payments for the license fees.
Previous report
The November AL001 License Agreements require us to pay royalty payments of 3% on net sales of products developed from the licensed technology for AL001 in those fields. We paid an initial license fee of $20,000 for the additional indications. Minimum royalties for November AL001 License Agreements are $40,000 on the first anniversary of the first commercial sale, $80,000 on the second anniversary of the first commercial sale and $100,000 on the third anniversary of the first commercial sale and every year thereafter, for the life of the November AL001 License Agreements.
Previous report
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 licensee’s obligations to pay royalties expire under the applicable license agreement. Under our various license agreements, if we fail to meet a milestone by its specified date, Licensor may terminate the license agreement. The Licensor was also granted a preemptive right to acquire such shares or other equity securities that may be issued from time to time by us while the Licensor remains the owner of any equity securities of our company.
Previous report
Additionally, we are required to pay milestone payments on the due dates to the Licensor for the license of the AL001 technologies and for the ALZN002 technology, as follows:
Previous report
Original AL001 Licenses:
Previous report
ALZN002 License:
Previous report
Additional AL001 Licenses:
Reworded paragraphs (31)
Previous wording
Certain of such 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.
Current wording
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.
Previous wording
Lithium is a commonly prescribed drug for manic episodes in BP type 1 as well as maintenance therapy of BP in patients with a history of manic episodes. Lithium is also prescribed off-label for MDD, BP and treatment of PTSD, among other disorders. Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option (considered the “gold standard”) but is underutilized perhaps because of the need for TDM. Lithium was the first drug that required TDM by regulatory authorities in product labelling because the effective and safe range of therapeutic drug blood concentrations is narrow and well defined for treatment of BP when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness.
Current wording
Lithium is a commonly prescribed drug for manic episodes in BD type 1 as well as maintenance therapy of BD in patients with a history of manic episodes. Lithium is also prescribed off-label for MDD, BD and treatment of PTSD, among other disorders. Lithium was the first mood stabilizer approved by the U.S. Food and Drug Administration (“FDA”) and is still a first-line treatment option (considered the “gold standard”) but is underutilized perhaps because of the need for TDM. Lithium was the first drug that required TDM by regulatory authorities in product labelling because the effective and safe range of therapeutic drug blood concentrations is narrow and well defined for treatment of BD when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness. Existing lithium drugs suffer from chronic toxicity, poor physicochemical properties, and poor brain bioavailability. Alzamend’s novel AL001 formulation, a lithium-salicylate/L-proline engineered ionic cocrystal, is designed to overcome the toxicities associated with conventional lithium salts, promising a next-generation lithium treatment with an enhanced safety profile and advantageous distribution to brain and brain structures.
Previous wording
Based on the results from our Phase IIA MAD study, we plan to initiate two safety and efficacy clinical trials in subjects with mild to moderate dementia of the Alzheimer’s type. Additionally, we are investigating the potential of AL001 for patients suffering from BD, MDD and PTSD, and submitted IND applications to the FDA for these indications. The IND for BD was submitted in August 2023 and we received a “study may proceed” letter from the FDA in September 2023. The IND for MDD was submitted in October 2023 and we received a “study may proceed” letter from the FDA in November 2023. The IND for PTSD was submitted in November 2023 and we received a “study may proceed” from the FDA in December 2023. We intend to initiate clinical trials in 2025 at this MTD to determine relative increased lithium levels in the brain compared to a marketed lithium salt for 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 a 300 mg TID lithium carbonate dose for treatment of BD with a 240 mg TID AL001 lithium equivalent, which represents a daily decrease of 20% of lithium given to a patient.
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. In August 2024, we announced that we had partnered with Massachusetts General Hospital to serve as the CRO for these clinical trials.
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 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; 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 IND application to the FDA for ALZN002 and received a “study may proceed” letter on October 31, 2022. The product candidate is an immunotherapy vaccine designed to treat mild to moderate dementia of the Alzheimer’s type. ALZN002 is a proprietary “active” immunotherapy product, which means it is produced by each patient’s immune system. It consists of autologous DCs that are activated white blood cells taken from each individual patient so that they can be engineered outside of the body to attack Alzheimer’s-related amyloid-beta proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s immune system to combat Alzheimer’s, with the goal being to foster tolerance to treatment for safety purposes while stimulating the immune system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms. Compared to passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with ALZN002 is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid. This could provide a safer approach due to its reliance on autologous immune components, using each individual patient’s own white blood cells rather than foreign cells and/or blood products.
Previous wording
Research and development expenses for the years ended April 30, 2024 and 2023 were $6.5 million and $7.4 million, respectively. As reflected in the table below, research and development expenses primarily consisted of professional fees, clinical trial fees, stock-based compensation expense, as well as other research and development expenses:
Current wording
Research and development expenses for the years ended April 30, 2025 and 2024 were $1.4 million and $6.5 million, respectively. As reflected in the table below, research and development expenses primarily consisted of professional fees, clinical trial fees, stock-based compensation expense, as well as other research and development expenses:
Previous wording
During the years ended April 30, 2024 and 2023, we incurred professional fees of $2.9 million and $4.6 million, respectively, which were primarily comprised of professional fees attributed to various types of scientific services, including FDA consulting services. The decrease relates to lower professional fees incurred related to the preparation for the clinical trial for ALZN002 during the year ended April 30, 2024, compared to professional fees incurred for the Phase IIA clinical trial for AL001 during the year ended April 30, 2023.
Current wording
During the years ended April 30, 2025 and 2024, we incurred professional fees of $656,000 and $2.9 million, respectively, which were primarily comprised of professional fees attributed to various types of scientific services, including FDA consulting services. The decrease relates to lower professional fees incurred during the year ended April 30, 2025, compared to professional fees incurred for the preparation for clinical trials for AL001 and ALZN002 during the year ended April 30, 2024.
Previous wording
During the years ended April 30, 2024 and 2023, we incurred clinical trial fees of $3.2 million and $2.5 million, respectively, Clinical trial fees for the year ended April 30, 2024, consisted of $1.9 million for our Phase IIA clinical trial for AL001 and $1.3 million for our Phase IIA clinical trial for ALZN002. Clinical trial fees for the year ended April 30, 2023 were for our Phase I clinical trial for AL001.
Current wording
During the years ended April 30, 2025 and 2024, we incurred clinical trial fees of $716,000 and $3.2 million, respectively. Clinical trial fees for the year ended April 30, 2025 were for our Phase IIA clinical trial for AL001. Clinical trial fees for the year ended April 30, 2024 were $1.9 million for our Phase IIA clinical trial for AL001 and $1.3 million for our Phase I clinical trial for ALZN002.
Previous wording
During the years ended April 30, 2024 and 2023, we incurred $214,000 and $(43,000), respectively, in research and development stock-based compensation expense related to stock option grants to consultants. The increase in research and development stock-based compensation expense for the year ended April 30, 2024 was a result of the vesting of performance stock options grants.
Current wording
During the year ended April 30, 2024, we incurred $214,000 in research and development stock-based compensation expense related to stock option grants to consultants. No such expense was incurred during the fiscal year ended April 30, 2025. The decrease in research and development stock-based compensation expense for the year ended April 30, 2025, was a result of all vested stock options grants having been expensed.
Previous wording
During the years ended April 30, 2024 and 2023, we incurred other fees of $96,000 and $405,000, respectively, which were primarily comprised of scientific materials required for our clinical trials.
Current wording
During the years ended April 30, 2025 and 2024, we incurred other fees of $43,000 and $96,000, respectively, which were primarily comprised of scientific materials required for our clinical trials.
Previous wording
General and administrative expenses for the years ended April 30, 2024 and 2023 were $3.5 million and $7.4 million, respectively. As reflected in the table below, general and administrative expenses primarily consisted of the following expense categories: stock-based compensation expense; salary and benefits; professional fees; marketing fees; insurance; travel and entertainment; as well as Board fees. For the years ended April 30, 2024 and 2023, the remaining general and administrative expenses of $381,000 and $514,000, respectively, primarily consisted of payments for advertising and promotion, transfer agent fees, travel, and other office expenses, none of which is significant individually.
Current wording
General and administrative expenses for the years ended April 30, 2025 and 2024 were $3.1 million and $3.5 million, respectively. As reflected in the table below, general and administrative expenses primarily consisted of the following expense categories: salary and benefits; professional fees; insurance; stock-based compensation expense; marketing fees; and Board fees. For the years ended April 30, 2025 and 2024, the remaining general and administrative expenses of $347,000 and $381,000, respectively, primarily consisted of payments for advertising and promotion, transfer agent fees, travel, and other office expenses, none of which is significant individually.
Previous wording
During the years ended April 30, 2024 and 2023, we incurred $836,000 and $1.0 million, respectively, in employee-related expenses. As of April 30, 2024, we had four full-time and three part-time employees. The decrease in salary and benefits expense was a result of lower bonuses earned during the year ended April 30, 2024.
Current wording
During the years ended April 30, 2025 and 2024, we incurred $1.0 million and $836,000, respectively, in employee-related expenses. As of April 30, 2025, we had four full-time and three part-time employees. The increase in salary and benefits expense was a result of higher bonuses earned during the year ended April 30, 2025.
Previous wording
During the years ended April 30, 2024 and 2023, we incurred professional fees of $736,000 and $762,000, respectively. During the year ended April 30, 2024, we incurred $341,000 in audit and tax fees, $192,000 in investor relations, $104,000 in legal fees, $33,000 in related party consulting, $28,000 in Sarbanes-Oxley compliance fees and $38,000 in other professional fees. During the year ended April 30, 2023, we incurred $189,000 in Sarbanes-Oxley compliance fees, $187,000 in connection with a consulting agreement, $187,000 in audit and tax fees, $126,000 in legal fees, $50,000 in related party consulting and $23,000 in other professional fees.
Current wording
During the years ended April 30, 2025 and 2024, we incurred professional fees of $618,000 and $736,000, respectively. During the year ended April 30, 2025, we incurred $243,000 in legal fees, $221,000 in audit and tax fees, $149,000 in investor relations and $5,000 in other professional fees. During the year ended April 30, 2024, we incurred $341,000 in audit and tax fees, $192,000 in investor relations, $104,000 in legal fees, $33,000 in related party consulting, $28,000 in Sarbanes-Oxley compliance fees and $38,000 in other professional fees.
Previous wording
During the years ended April 30, 2024 and 2023, we incurred insurance expense of $382,000 and $587,000, respectively, which was primarily directors and officers insurance.
Current wording
During the years ended April 30, 2025 and 2024, we incurred insurance expense of $259,000 and $382,000, respectively, which was primarily directors and officers insurance. The decrease in insurance expense was due to lower negotiated pricing with the same amount of coverage.
Previous wording
During the years ended April 30, 2024 and 2023, we incurred general and administrative stock-based compensation expense of $741,000 and $3.6 million, respectively, related to stock option grants to executives, employees and consultants. The decrease in stock-based compensation expense for the year ended April 30, 2024 was a result of fewer stock options vesting during the period compared to the prior year period.
Current wording
During the years ended April 30, 2025 and 2024, we incurred stock-based compensation expense of $325,000 and $741,000, respectively, related to stock option grants to executives, employees and consultants. The decrease in stock-based compensation expense for the year ended April 30, 2025 was a result of fewer stock options vesting during the period compared to the prior year period.
Previous wording
During the years ended April 30, 2024 and 2023, we incurred marketing fees of $247,000 and $743,000, respectively, which was primarily expenses related to the marketing and brand development agreement with AULT.
Current wording
During the years ended April 30, 2025 and 2024, we incurred marketing fees of $347,000 and $247,000, respectively, which was primarily expenses related to the marketing and branding of our company.
Previous wording
As of April 30, 2024 and 2023, we had deferred tax assets totaling $15.8 million and $10.8 million, respectively. The ultimate realization of deferred tax assets is dependent upon the existence, or generation, of taxable income in the periods when those temporary differences and net operating loss carryovers are deductible. Management considers the scheduled reversal of deferred tax liabilities, taxes paid in carryover years, projected future taxable income, available tax planning strategies, and other factors in making this assessment. Based on available evidence, management believes it is more likely than not that some or all of the deferred tax assets will not be realized. Accordingly, we have established a 100% valuation allowance. As a result of the full valuation allowance, we did not record an income tax benefit for the years ended April 30, 2024 and 2023.
Current wording
As of April 30, 2025 and 2024, we had deferred tax assets totaling $15.2 million and $15.8 million, respectively. The ultimate realization of deferred tax assets is dependent upon the existence, or generation, of taxable income in the periods when those temporary differences and net operating loss carryovers are deductible. Management considers the scheduled reversal of deferred tax liabilities, taxes paid in carryover years, projected future taxable income, available tax planning strategies, and other factors in making this assessment. Based on available evidence, management believes it is more likely than not that some or all of the deferred tax assets will not be realized. Accordingly, we have established a 100% valuation allowance. As a result of the full valuation allowance, we did not record an income tax benefit for the years ended April 30, 2025 and 2024.
Previous wording
Our inability to continue as a going concern could have a negative impact on our company, including our ability to obtain needed financing. We intend to finance our future development activities and our working capital needs largely through the sale of equity securities with some additional funding from other sources, including debt financing, until such time as funds provided by operations are sufficient to fund working capital requirements. Our 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 April 30, 2024, we had cash of $376,000 and an accumulated deficit of $54.0 million. We have incurred recurring losses and reported losses for the year ended April 30, 2024 totaling $9.9 million. 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, including our ability to obtain needed financing. We intend to finance our future development activities and our working capital needs largely through the sale of equity securities with some additional funding from other sources, including debt financing, until such time as funds provided by operations are sufficient to fund working capital requirements. Our 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 April 30, 2025, we had cash of $3.9 million and an accumulated deficit of $58.5 million. We have incurred recurring losses and reported losses for the year ended April 30, 2025 totaling $4.5 million. In the past, we have financed our operations principally through sales of equity securities 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. As previously disclosed, we had anticipated beginning Phase II clinical trials for AL001 additional indications in the first quarter of calendar 2024. Due to the Company’s inability to obtain significant additional financing, we have been unable to initiate those clinical trials and reduce the working capital deficiency. 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. Our future capital requirements will depend on many factors, including:
Previous wording
On September 8, 2023, we entered into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC, as sales agent to sell shares of our common stock, having an aggregate offering price of up to approximately $9.8 million from time to time, through an “at the market offering” (the “ATM Offering”) as defined in Rule 415 under the Securities Act. On September 8, 2023, we filed a prospectus supplement with the SEC relating to the offer and sale of up to approximately $9.8 million in shares of common stock in the ATM Offering.
Current wording
On September 8, 2023, we entered into an At-the-Market Issuance Sales Agreement with Ascendiant Capital Markets, LLC (“Ascendiant”), as sales agent to sell shares of our Common Stock, having an aggregate offering price of up to approximately $9.8 million from time to time, through an “at the market offering” (the “ATM Offering”) as defined in Rule 415 under the Securities Act. On September 8, 2023, we filed a prospectus supplement with the SEC relating to the offer and sale of up to approximately $9.8 million in shares of Common Stock in the ATM Offering.
Previous wording
During the year ended April 30, 2024, we sold an aggregate of 107,682 shares of common stock pursuant to the ATM Offering for proceeds of $1.3 million. On May 6, 2024, we terminated our ATM Offering.
Current wording
During the year ended April 30, 2024, we sold an aggregate of 11,964 shares of Common Stock pursuant to the ATM Offering for proceeds of $1.3 million. On May 6, 2024, we terminated our ATM Offering.
Previous wording
On January 31, 2024, we entered into a securities purchase agreement with Ault Lending (“AL SPA”) whereby Ault Lending may purchase of up to 6,000 shares of series B convertible preferred stock (“Series B Convertible Preferred Stock”) and warrants to purchase shares up to 600,000 shares of our common stock. The AL SPA provides that Ault Lending may purchase up to $6 million of Series B Convertible Preferred Stock in one or more closings. Ault Lending has the right to purchase up to $2 million of Series B Convertible Preferred Stock, on or before March 31, 2024, and the right to purchase up to $4 million of Series B Convertible Preferred Stock after March 31, 2024, but on or before March 31, 2025 (the “Termination Date”). The Agreement will automatically terminate if the final closing has not occurred prior to the Termination Date.
Current wording
On January 31, 2024, we and Ault Lending entered into a securities purchase agreement (the “AL SPA”) for the purchase of up to 6,000 shares of Series B Convertible Preferred Stock and warrants to purchase shares up to 66,667 shares of Common Stock. The AL SPA provided that Ault Lending could have purchased up to $6 million of Series B Convertible Preferred Stock in one or more closings. Ault Lending had the right to purchase up to $2 million of Series B Convertible Preferred Stock, on or before March 31, 2024, and the right to purchase up to $4 million of Series B Convertible Preferred Stock after March 31, 2024, but on or before March 31, 2025 (the “Termination Date”). The final closing did not occur prior to the Termination Date and the AL SPA automatically terminated.
Previous wording
On January 31, 2024, we sold 1,220 shares of Series B Convertible Preferred Stock and warrants to purchase 122,000 shares of common stock with an exercise price of $12.00, for a total purchase price of $1.22 million. The purchase price was paid by the cancellation of $1.15 million of cash advances made by Ault Lending to us between November 9, 2023 and January 31, 2024 and a subscription receivable of $70,000. On March 26, 2024, we sold 780 shares of Series B Convertible Preferred Stock and warrants to purchase 78,000 shares of common stock with an exercise price of $12.00, for a total purchase price of $780,000. On April 29, 2024, we sold 100 shares of Series B Convertible Preferred Stock and warrants to purchase 10,000 shares of common stock with an exercise price of $12.00, for a total purchase price of $100,000.
Current wording
Between January 31, 2024 and April 29, 2024, we sold an aggregate of 2,100 shares of Series B Convertible Preferred Stock and warrants to purchase 23,333 shares of common stock with an exercise price of $108.00, for a total purchase price of $2.1 million. The purchase price was paid by the cancellation of $1.15 million of cash advances made by Ault Lending to us between November 9, 2023 and January 31, 2024 and a subscription receivable of $70,000 and further cash proceeds of $880,000.
Previous wording
On May 8, 2024, we and Orchid Finance, LLC (“Orchid”), entered into a securities purchase agreement (the “Orchid SPA”) for the purchase of up to 2,500 shares of Series A Convertible Preferred Stock (“Series A Convertible Preferred Stock”) and warrants to purchase shares up to 2,500,000 shares of common stock in several tranche closings.
Current wording
On May 8, 2024, we and Orchid Finance, LLC (“Orchid”), entered into a securities purchase agreement (the “Orchid SPA”) for the purchase of up to 2,500 shares of Series A Convertible Preferred Stock (“Series A Convertible Preferred Stock”) and warrants to purchase shares up to 277,778 shares of common stock in several tranche closings.
Previous wording
On May 10, 2024, we sold 100 shares of Series A Convertible Preferred Stock and warrants to purchase 80,000 shares of common stock with an exercise price of $12.50, for a total purchase price of $1.0 million. The purchase price was paid by the surrender and cancellation of a term note issued by us to Orchid of $311,356, consisting of $310,000 of principal and $1,356 of accrued and unpaid interest, $100,000 discount and net cash of $588,644. On June 25, 2024, we sold 150 shares of Series A Convertible Preferred Stock and warrants to purchase 120,000 shares of common stock with an exercise price of $12.50, for a total purchase price of $1.5 million. The purchase price was paid in cash.
Current wording
Between May 10, 2024 and September 11, 2024, we sold an aggregate of 800 shares of Series A Convertible Preferred Stock and warrants to purchase an aggregate of 71,109 shares of Common Stock with an exercise price of $112.50, for a total purchase price of $8.0 million. The purchase price was paid by the surrender and cancellation of a term note issued by us to Orchid of $311,356, consisting of $310,000 of principal and $1,356 of accrued and unpaid interest, $200,000 discount and net cash of $7.5 million.
Previous wording
Notwithstanding the foregoing Milestones, Orchid has the ability to invest any amount in its sole discretion in advance of the dates that the foregoing Milestones shall have been met. In the event that the average closing price of the common stock during the three trading days preceding the date of a tranche closing shall not be equal to or greater than $2.50 a share (the “Floor Price”), then the applicable closing shall be delayed until such time as the price meets the required threshold. We agreed to pay Ault Lending an origination fee of five percent (5%) of the total gross proceeds we receive from Orchid upon each purchase of Series A Convertible Preferred Stock. We also agreed to pay Orchid a fee of $100,000 upon the first closing, which occurred on May 10, 2024, the Fourth Tranche and the third, eighth and thirteenth closings constituting parts of the Final Tranche.
Current wording
Pursuant to the Orchid SPA, Orchid had agreed to purchase the remaining 1,700 Preferred Shares on each monthly anniversary of the effectiveness of a registration statement until all remaining 1,700 Preferred Shares had been sold (“Milestones”). Orchid had the ability to invest any amount in its sole discretion in advance of the Milestone dates. In the event that the average closing price of the Common Stock during the three trading days preceding the date of a tranche closing was not equal to or greater than $22.50 a share (the “Floor Price”), then the applicable closing would be delayed until such time as the price meet the required threshold. Weagreed to pay Ault Lending an origination fee of five percent (5%) of the total gross proceeds we receive from Orchid upon each purchase of Series A Convertible Preferred Stock. We also agreed to pay Orchid a fee of $100,000 upon the first closing, which occurred on May 10, 2024, and on the closing which occurred on August 21, 2024.
Previous wording
The warrants have an exercise price of $12.50 (the “Series AExercise Price”) and are exercisable upon issuance and have a five-year term, expiring on the fifth anniversary of issuance. The Series AExercise Price is subject to adjustment in the event of an issuance of common stock at a price per share lower than the Series AExercise Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The warrants are exercisable on a cashless basis in the event that there is not then an effective resale registration statement for the common stock issuable upon exercise of the warrants.
Current wording
The warrants had an exercise price of $112.50 (the “Series AExercise Price”) and were exercisable upon issuance and had a five-year term, expiring on the fifth anniversary of issuance. The Series AExercise Price were subject to adjustment in the event of an issuance of Common Stock at a price per share lower than the Series AExercise Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The warrants were exercisable on a cashless basis in the event that there is not then an effective resale registration statement for the Common Stock issuable upon exercise of the warrants.
Previous wording
The Registration Statement registering for resale the shares of common stock issuable upon conversion of the Series A Convertible Preferred Stock and exercise of the warrants was declared effective on July 9, 2024. In addition, we agreed to use our best efforts to hold a special meeting of our stockholders within 90 days of the execution date of the Orchid SPA for purposes of seeking stockholder approval of the issuance of all the shares of common stock issuable upon conversion of the Series A Convertible Preferred Stock and the exercise of the warrants in excess of the “Nasdaq Limit”, which is 19.99% of our shares of common stock issued and outstanding on the execution date of the Orchid SPA. We held a special meeting of stockholders on July 8, 2024, at which time, the stockholders approved the issuance of all the shares of common stock issuable upon conversion of the Series A Convertible Preferred Stock and the exercise of the warrants in excess of the “Nasdaq Limit”.
Current wording
The registration statement registering for resale the shares of Common Stock issuable upon conversion of the Series C Convertible Preferred Stock and exercise of the warrants was declared effective on April 8, 2025. In addition, we agreed to use our best efforts to hold a meeting of our stockholders within 90 days of the execution date of the Orchid SPEA for purposes of seeking stockholder approval of the issuance of all the shares of Common Stock issuable upon conversion of the Series C Convertible Preferred Stock and the exercise of the warrants in excess of the “Nasdaq Limit”, which is 19.99% of the shares of Common Stock issued and outstanding on the execution date of the Orchid SPEA. We held our annual meeting of stockholders on April 25, 2025, at which time, the stockholders approved the issuance of all the shares of Common Stock issuable upon conversion of the Series C Convertible Preferred Stock and the exercise of the warrants in excess of the “Nasdaq Limit”.
Previous wording
The Series A Convertible Preferred Stockhas a stated value of $10,000 per share (“Series A Stated Value”) and accrues dividendsat the rate of 15% per annum, payable quarterly in arrears in cash or paid-in-kind shares, in Orchid’s sole discretion. Each share of Series A Convertible Preferred Stock is convertible into a number of shares of common stock determined by dividing the Series A Stated Valueby(y) the greater of (i) the Floor Price and (ii) the lesser of (A) $15.00 and (B) 80% of the lowest closing price of our common stock during the three trading days immediately prior to the date of conversion into conversion shares (the “Series AConversion Price”). The Series AConversion Price is subject to adjustment in the event of an issuance of common stock at a price per share lower than the Series AConversion Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The holders of the Series A Convertible Preferred Stock are entitled to vote with the common stock as a single class on an as-converted basis, subject to applicable law provisions of the Delaware General 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 B Convertible Preferred Stock is entitled to cast, shall not be lower than $5.63 (the “Series A Voting Floor Price”), which represents the closing sale price of the common stock on the trading day immediately prior to the date of execution of the Orchid SPA. The Series A Voting Floor Price shall be adjusted for stock dividends, stock splits, stock combinations and other similar transactions.
Current wording
The Series C Convertible Preferred Stockhas a stated value of $10,000 per share (“Series C Stated Value”) and accrued dividendsat the rate of 15% per annum, payable quarterly in arrears in cash or paid-in-kind shares, in Orchid’s sole discretion. Each share of Series C Convertible Preferred Stock is convertible into a number of shares of Common Stock determined by dividing the Series C Stated Valueby(y) the greater of (i) $0.90 per share (“Series C Floor Price”) and (ii) the lesser of (A) $135.00 and (B) 80% of the lowest closing price of our Common Stock during the three trading days immediately prior to the date of conversion into conversion shares (the “Series CConversion Price”). The Series CConversion Price was subject to adjustment in the event of an issuance of Common Stock at a price per share lower than the Series CConversion Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events. The holders of the Series C Convertible Preferred Stock were entitled to vote with the Common Stock as a single class on an as-converted basis, subject to applicable law provisions of the Delaware General Corporation Law and Nasdaq, provided however, that for purposes of complying with Nasdaq regulations, the conversion price, for purposes of determining the number of votes the holder of Series C Convertible Preferred Stock is entitled to cast, shall not be lower than $7.5375 (the “Series C Voting Floor Price”), which represents the closing sale price of the Common Stock on the trading day immediately prior to the date of execution of the Orchid SPEA. The Series C Voting Floor Price shall be adjusted for stock dividends, stock splits, stock combinations and other similar transactions.
Previous wording
During the year ended April 30, 2023, net cash used in operating activities was $8.9 million. This consisted primarily of a net loss of $14.9 million, partially offset by non-cash charges of $3.6 million in stock-based compensation expense and an increase in our net operating assets and liabilities of $2.3 million. The increase in our net operating assets and liabilities was primarily due to an increase in accounts payable and accrued liabilities and a decrease in prepaid expenses – related party.
Current wording
During the year ended April 30, 2025, net cash used in operating activities was $6.6 million. This consisted primarily of a net loss of $4.5 million and a decrease in our net operating assets and liabilities of $2.4 million, partially offset by stock-based compensation of $325,000. The decrease in our net operating assets and liabilities was primarily due to a decrease in accounts payable and accrued liabilities and an increase in prepaid expenses.
Previous wording
During the year ended April 30, 2024, net cash used in investing activities was $147,000, from the purchase of equipment and machinery to be used in our ALZN002 Phase I/IIA clinical trial.
Current wording
During the year ended April 30, 2025, net cash used in investing activities was $300,000, from the purchase of equipment and machinery being used in our AL001 Phase II clinical trials.
Previous wording
During the year ended April 30, 2023, net cash provided by financing activities was $200 from the exercise of stock options.
Current wording
During the year ended April 30, 2025, net cash provided by financing activities was $7.7 million from the sale of convertible preferred stock and $2.7 million from proceeds from the New ATM Offering.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
On October 3, 2024, we entered into a new At-the-Market Issuance Sales Agreement with Ascendiant, as sales agent to sell shares of our Common Stock, having an aggregate offering price of up to approximately $6.5 million from time to time, through an “at the market offering” (the “New ATM Offering”) as defined in Rule 415 under the Securities Act. On October 3, 2024, we filed a prospectus supplement with the SEC relating to the offer and sale of up to approximately $6.5 million in shares of Common Stock in the New ATM Offering.
Current report — wording carried from elsewhere
During the year ended April 30, 2025, we sold an aggregate of 235,904 shares of Common Stock pursuant to the New ATM Offering for proceeds of $2.7 million. On April 7, 2025, we terminated our New ATM Offering.
Current report — wording carried from elsewhere
The Series A Convertible Preferred Stockhad a stated value of $10,000 per share (“Series A Stated Value”) and accrued dividendsat the rate of 15% per annum, payable quarterly in arrears in cash or paid-in-kind shares, in Orchid’s sole discretion. Each share of Series A Convertible Preferred Stock was convertible into a number of shares of Common Stock determined by dividing the Series A Stated Valueby(y) the greater of (i) the Floor Price and (ii) the lesser of (A) $135.00 and (B) 80% of the lowest closing price of our Common Stock during the three trading days immediately prior to the date of conversion into conversion shares (the “Series AConversion Price”). The Series AConversion Price was subject to adjustment in the event of an issuance of Common Stock at a price per share lower than the Series AConversion Price then in effect, as well as upon customary stock splits, stock dividends, combinations or similar events.