Item 7. Management’s Discussion and Analysis
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and
analysis of our financial condition and results of our operations together with our financial statements and the notes thereto appearing
elsewhere in this Annual Report. This discussion contains forward-looking statements reflecting our current expectations, whose actual
outcomes involve risks and uncertainties. Actual results and the timing of events may differ materially from those stated in or implied
by these forward-looking statements due to a number of factors, including those discussed in the sections entitled “Risk Factors”
and “Special Note Regarding Forward-Looking Statements,” and elsewhere in this Annual Report.
Overview
We were incorporated on February
26, 2016, as Alzamend Neuro, Inc. under the laws of the State of Delaware. We were formed to acquire and commercialize patented intellectual
property and know-how to prevent, treat and potentially cure the crippling and deadly Alzheimer’s. With our two product candidates,
we aim to bring treatment or cures not only for Alzheimer’s, but also, bipolar disorder (“BD”), major depressive disorder
(“MDD”) and post-traumatic stress disorder (“PTSD”). Existing Alzheimer’s treatments only temporarily relieve
symptoms but do not, to our knowledge, slow or halt the underlying worsening of the disease. We have developed a novel approach to combat
Alzheimer’s through immunotherapy.
Critical Accounting Policies and Estimates
Stock-Based Compensation. We
maintain a stock-based compensation plan as a long-term incentive for employees, non-employee directors and consultants. The plan allows
for the issuance of incentive stock options, non-qualified stock options, restricted stock units, and other forms of equity awards.
We recognize stock-based compensation
expense for stock options on a straight-line basis over the requisite service period and account for forfeitures as they occur. Our stock-based
compensation costs are based upon the grant date fair value of options estimated using the Black-Scholes option pricing model. To the
extent any stock option grants are made subject to the achievement of a performance-based milestone, management evaluates when the achievement
of any such performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting
date.
The Black-Scholes option pricing
model utilizes inputs which are highly subjective assumptions and generally require significant judgment. These assumptions include:
· Risk-Free Interest Rate. The risk-free interest rate is based on the U.S. Treasury
zero coupon issues in effect at the time of grant for periods corresponding with the expected term of the option.
· Expected Volatility. Because we do not have a sufficient trading history for our common
stock (“Common Stock”), the expected volatility was estimated based on the average volatility for comparable publicly traded
life sciences companies over a period equal to the expected term of the stock option grants. The comparable companies were chosen based
on the similar size, stage in life cycle or area of specialty. We will continue to apply this process until a sufficient amount of historical
information regarding the volatility of our own stock price becomes available.
· Expected Term. The expected term represents the period that the stock-based awards
are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the
end of the contractual term), as we do not have sufficient historical data to use any other method to estimate expected term.
· Expected Dividend Yield. We have never paid dividends on our Common Stock and have
no plans to pay dividends on our Common Stock. Therefore, we used an expected dividend yield of zero.
Certain of these assumptions involve inherent uncertainties and the
application of significant judgment. As a result, if factors or expected outcomes change and we use significantly different assumptions
or estimates, our stock-based compensation could be materially different.
Income Taxes. We
recognize deferred income taxes for the future tax consequences attributed to differences between the financial statement carrying amounts
of existing assets and liabilities and their respective tax bases, operating loss and tax credit carryforwards. Deferred tax assets are
reduced by a valuation allowance to the extent management concludes it is more likely than not that the assets will not be realized. Deferred
tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the fiscal years in which those
temporary differences are expected to be recovered or settled.
In accordance with Internal
Revenue Code §382 (“IRC §382”), the future deductibility of our net operating losses (“NOLs”) may be
subject to an annual limitation in the event of a change in control as defined by applicable regulations. We have yet to complete a formal
study to confirm NOLs are not limited in utilization per IRC §382 and may reduce applicable deferred tax assets upon completion of
such a study, in future periods.
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The impact of an uncertain
income tax position on the income tax return must be recognized at the largest amount that is more likely than not to be sustained upon
audit by the relevant taxing authority. An uncertain income tax position will not be recognized if it has less than a 50% likelihood of
being sustained. We had no uncertain tax positions as of April 30, 2026.
Preferred Stock Classification.
We analyze the terms of our preferred stock using Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities
from Equity , to determine whether our preferred stock should be classified as a liability or equity, and if classified as equity,
permanent or temporary. Common criteria we consider are redemption provisions, conversion options, cumulative of mandatory fixed dividends,
discretionary dividends based on earning, voting rights and collateral requirements.
Plan of Operations
We intend to develop and commercialize
therapeutics that are better than existing treatments and have the potential to significantly improve the lives of individuals afflicted
by Alzheimer’s, BD, MDD and PTSD. To achieve these goals, we are pursuing the following key business strategies:
· Advance clinical development of AL001 for Alzheimer’s, BD, MDD and PTSD treatment;
· Advance clinical development of ALZN002 for Alzheimer’s treatment;
· Expand our pipeline of pharmaceuticals to include additional indications for AL001 and delivery methods;
· Focus on translational and functional endpoints to efficiently develop product candidates; and
· Optimize the value of AL001 and ALZN002 in major markets.
Our pipeline consists of two
novel therapeutic drug candidates:
· AL001 - A patented ionic cocrystal technology delivering a therapeutic combination of lithium, salicylate
and proline through three royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.,
as licensor (the “Licensor”); and
· ALZN002 - A patented method using a mutant peptide sensitized cell as a cell-based therapeutic vaccine
that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s through a royalty-bearing exclusive
worldwide license from the Licensor.
Our most advanced product
candidate (lead product) licensed and in clinical development in humans is AL001, an ionic cocrystal of lithium for the treatment of Alzheimer’s,
BD, MDD and PTSD. Based on our preclinical data involving mice models, AL001 treatment prevented cognitive deficits, depression and irritability
and is superior in improving associative learning and memory and irritability compared with lithium carbonate treatments, supporting the
potential of this lithium formulation for the treatment of Alzheimer’s, BD, MDD and PTSD in humans. Lithium has been marketed for
more than 35 years and human toxicology regarding lithium use has been well characterized, potentially mitigating the regulatory burden
for safety data.
On May 5, 2022, we initiated
a multiple-dose, steady-state, double-blind, ascending dose safety, tolerability, pharmacokinetic clinical trial of AL001 in patients
with mild to moderate Alzheimer’s and healthy subjects. We completed the Phase IIA clinical trial in March 2023 and announced positive
topline data in June 2023.
We announced that we successfully
identified a maximum tolerated dose (“MTD”) for development of AL001 from a multiple-ascending dose study as assessed by an
independent safety review committee. This dose, providing lithium at a lithium carbonate equivalent dose of 240 mg 3-times daily (“TID”),
is designed to be unlikely to require lithium therapeutic drug monitoring (“TDM”). Also, this MTD is risk-mitigated for the
purpose of treating fragile populations, such as Alzheimer’s patients.
Based on the results from
our Phase IIA MAD study, we plan to initiate five clinical trials to determine relative increased lithium levels in the brain compared
to a marketed lithium salt for healthy subject and patients diagnosed with mild to moderate Alzheimer’s, BD, MDD and PTSD, based
on published mouse studies that predict that lithium can be given at lower doses for equivalent therapeutic benefit when treating with
AL001. For example, the goal is to replace the amount of lithium needed for maintenance treatment of BD with a clinically relevant, lower
AL001 lithium carbonate equivalent lithium dose. Such lithium dose mitigation could redefine the landscape of neuropsychiatric, neurodegenerative,
and neurological treatment practices.
In August 2024, we announced
a partnership with MGH and Harvard Medical School to conduct five Phase II imaging clinical trials. The purpose of these trials is to
assess the comparative increase in lithium levels within the brain and its structures as opposed to a commonly marketed lithium salt among
healthy subjects and patients afflicted with Alzheimer’s, BD, MDD and PTSD.
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In November 2024, we announced
a full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer’s
transgenic mice. This study was a precursor to the five clinical trials and showed that AL001 exhibited consistently higher lithium concentrations
in brain tissues, particularly at lower doses, compared to lithium carbonate.
For these clinical trials,
we partnered with Tesla Dynamic Coils BV to create a head coil to enable whole-brain imaging of lithium with remarkable resolution, allowing
precise quantification within brain structures. The coil will be used to help identify the disease-specific target doses of AL001 that
improve the balance of safety and efficacy compared to lithium carbonate. The coil will also be used to scan the entire brain, helping
us clearly identify the different structures and important areas necessary for understanding how lithium works and moves within the brain.
We announced completion of the head coil in February 2025.
In May 2025, we announced
the initiation, enrollment and dosing of the first patient for the healthy human patients. This clinical trial has the following objectives:
· To assess lithium brain/plasma pharmacokinetics (“PK”) of the AL001 oral capsule relative
to a marketed lithium carbonate capsule in healthy adult subjects for the purpose of determining potential clinically safe and effective
AL001 dosing in future studies;
· To characterize AL001 lithium and salicylate steady-state plasma PK, and lithium relative to a marketed
lithium carbonate capsule;
· To characterize differences in brain and brain structure(s) PK behaviors such as absorption and persistence
between AL001 capsule and a marketed lithium carbonate capsule; and
· To characterize safety and tolerability of the tested formulations under the conditions of this study
(38% below the pre-determined MTD for AL001, at a half-dose of a usual lithium starting dose of lithium carbonate for treatment of BD,
equivalent to 150 mg lithium carbonate TID).
In November 2025, we announced
the completion of the clinical portion of this study and reported pharmacokinetics topline data in March 2026, with the following results:
(1) Bioequivalence Confirmed: AL001 delivered 101% of total lithium blood exposure and 97% of peak lithium levels vs. standard lithium
carbonate; (2) Superior Brain Penetration: AL001 showed numerically higher lithium concentrations in all measured brain regions, including
whole brain; and (3) Faster Brain Uptake: AL001 reached peak brain concentration in 6.7 hours vs. 8.4 hours for standard lithium carbonate.
In April 2026, we announced pharmacodynamic topline data of the healthy human subjects with the following results:
· Potentially Distinct Brain Profile: Across multiple brain regions, AL001 and lithium
carbonate appeared to trend in opposite directions in brain chemistry measures, suggesting that AL001 may interact with the brain in a
distinct manner and generate a lower neurochemical footprint than lithium carbonate;
· Expected Trends for Myo-Inositol Reduction: Both AL001 and lithium carbonate showed a trend toward reducing
myo-inositol, potentially supporting the hypothesis that AL001 retains lithium's core mechanism of action; and
· Potentially Preserved Glutamate Balance: Lithium carbonate showed large effects across all brain
regions whereas AL001 showed minimal glutamate effect in most brain regions, which may suggest better long-term tolerability.
Full pharmacokinetics and
pharmacodynamic results are expected in August 2026.
In March 2026, we announced
the initiation of the Phase II Clinical Trial of AL001 “Lithium in Brain” Study in Patients with BD and expect to report topline
data in the fourth quarter of 2026. The clinical trials for treatment of patients with MDD and PTSD are expected to commence in the fourth
quarter of 2026, followed by Alzheimer’s in the first quarter of 2027. These projected timelines reflect our commitment to advancing
our clinical development programs across multiple neuropsychiatric and neurodegenerative indications.
On September 28, 2022, we
submitted an Investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (the “FDA”)
for ALZN002 and received a “study may proceed” letter on October 31, 2022. The product candidate is an immunotherapy vaccine
designed to treat mild to moderate dementia of the Alzheimer’s type. ALZN002 is a proprietary “active” immunotherapy
product, which means it is produced by each patient’s immune system. It consists of autologous DCs that are activated white blood
cells taken from each individual patient so that they can be engineered outside of the body to attack Alzheimer’s-related amyloid-beta
proteins. These DCs are pulsed with a novel amyloid-beta peptide (E22W) designed to bolster the ability of the patient’s immune
system to combat Alzheimer’s, with the goal being to foster tolerance to treatment for safety purposes while stimulating the immune
system to reduce the brain’s beta-amyloid protein burden, resulting in reduced Alzheimer’s signs and symptoms. Compared to
passive immunization treatment approaches that use foreign blood products (such as monoclonal antibodies), active immunization with ALZN002
is anticipated to offer a more robust and long-lasting effect on the clearance of amyloid. This could provide a safer approach due to
its reliance on autologous immune components, using each individual patient’s own white blood cells rather than foreign cells and/or
blood products.
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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 in first quarter of 2027.
The continuation of our current
plan of operations with respect to completing our IND applications and conducting the series of human clinical trials for each of our
therapeutics requires us to raise additional capital to fund our operations.
Because our working capital
requirements depend upon numerous factors, including the progress of our preclinical and clinical testing, timing and cost of obtaining
regulatory approvals, changes in levels of resources that we devote to the development of manufacturing and marketing capabilities, competitive
and technological advances, status of competitors, and our ability to establish collaborative arrangements with other organizations, we
will require additional financing to fund future operations.
Results of Operations
Results of Operations for the Year Ended April 30, 2026 Compared
to the Year Ended April 30, 2025
The following table summarizes
the results of our operations for the years ended April 30, 2026 and 2025:
For the Years Ended April 30,
2026
2025
$ Change
% Change
OPERATING EXPENSES
Research and development
$ 3,629,785
$ 1,414,928
$ 2,214,857
157 %
General and administrative
5,137,056
3,081,896
2,055,160
67 %
Total operating expenses
8,766,841
4,496,824
4,270,017
95 %
Loss from operations
(8,766,841 )
(4,496,824 )
(4,270,017 )
95 %
OTHER INCOME (EXPENSE), NET
Interest income
1,078
-
1,078
*
Interest expense
(6,619 )
(18,029 )
11,410
-63 %
Total other expense, net
(5,541 )
(18,029 )
12,488
-69 %
NET LOSS
(8,772,382 )
(4,514,853 )
(4,257,529 )
94 %
Dividend on preferred shares
-
(117,022 )
117,022
*
Deemed dividend on warrant modification issued with preferred shares
-
(473,209 )
473,209
*
NET LOSS AVAILABLE TO COMMON SHARES
$ (8,772,382 )
$ (5,105,084 )
$ (3,667,298 )
72 %
Basic and diluted net loss per common share
$ (2.63 )
$ (11.32 )
$ 8.69
*
Basic and diluted weighted average common shares outstanding
3,337,143
450,799
*
* Not meaningful
Revenue
We currently have only two
product candidates, AL001 and ALZN002. These products are in the clinical stage of development and will require extensive clinical study,
review and evaluation, regulatory review and approval, significant marketing efforts and substantial investment before either or both
of them, and any respective successors, will provide us with any revenue. We did not generate any revenues during the years ended April
30, 2026 and 2025, and we do not anticipate that we will generate revenue for the foreseeable future.
- 49 -
Research and Development Expenses
Research and development expenses
for the years ended April 30, 2026 and 2025 were $3.6 million and $1.4 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:
For the Years Ended April 30,
2026
2025
$ Change
% Change
Professional fees
$ 625,250
$ 655,659
$ (30,409 )
-5 %
Stock-based compensation expense
46,611
-
46,611
*
Clinical trial fees
2,934,775
716,318
2,218,457
310 %
Other research and development expenses
23,149
42,951
(19,802 )
-46 %
Total research and development expenses
$ 3,629,785
$ 1,414,928
$ 2,214,857
157 %
* Not meaningful
Professional Fees
During the years ended April
30, 2026 and 2025, we incurred professional fees of $625,000 and $656,000, respectively, which were primarily comprised of professional
fees attributed to various types of scientific services, including FDA consulting services. The decrease relates to lower professional
fees incurred during the year ended April 30, 2026, compared to professional fees incurred for the preparation for clinical trials for
AL001 and ALZN002 during the year ended April 30, 2025.
Stock-Based Compensation Expense
During the year ended April
30, 2026, we incurred $47,000 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 increase in research and development stock-based compensation
expense for the year ended April 30, 2026, was a result of the expense recorded as a result of the vesting of newly granted stock options.
Clinical Trial Fees
During the years ended April
30, 2026 and 2025, we incurred clinical trial fees of $2.9 million and $716,000, respectively. Clinical trial fees for the year ended
April 30, 2026 were for our Phase IIB clinical trial for AL001 for healthy subjects. Clinical trial fees for the year ended April 30,
2025 were for our Phase IIA clinical trial for AL001.
Other Research and Development Expenses
During the years ended April
30, 2026 and 2025, we incurred other fees of $23,000 and $43,000, respectively, which were primarily comprised of scientific materials
required for our clinical trials.
General and Administrative Expenses
General and administrative
expenses for the years ended April 30, 2026 and 2025 were $5.1 million and $3.1 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, 2026 and 2025, the remaining general and
administrative expenses of $469,000 and $347,000, respectively, primarily consisted of payments for franchise taxes, depreciation, transfer
agent fees, travel, and other office expenses, none of which is significant individually.
For the Years Ended April 30,
2026
2025
$ Change
% Change
Salary and benefits
$ 988,076
$ 1,010,487
$ (22,411 )
-2 %
Professional fees
2,176,864
617,650
1,559,214
252 %
Insurance
236,279
259,382
(23,103 )
-9 %
Stock-based compensation expense
660,916
325,108
335,808
103 %
Marketing fees
425,000
347,295
77,705
22 %
Board of director fees
181,250
175,000
6,250
4 %
Other general and administrative expenses
468,671
346,974
121,697
35 %
Total general and administrative expenses
$ 5,137,056
$ 3,081,896
$ 2,055,160
67 %
- 50 -
Salary and Benefits
During the years ended April
30, 2026 and 2025, we incurred $988,000 and $1.0 million, respectively, in employee-related expenses. As of April 30, 2026, we had four
full-time and two part-time employees. The decrease in salary and benefits expense was a result of the reduction of one part-time employee
during the year ended April 30, 2026.
Professional Fees
During the years ended April
30, 2026 and 2025, we incurred professional fees of $2.2 million and $618,000, respectively. During the year ended April 30, 2026, we
incurred $1.9 million in legal fees, $190,000 in audit and tax fees, $95,000 in investor relations and $7,000 in other professional fees.
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. 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 August 2026.
Insurance Expense
During the years ended April
30, 2026 and 2025, we incurred insurance expense of $236,000 and $259,000, 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.
Stock-based Compensation Expense
During the years ended April
30, 2026 and 2025, we incurred stock-based compensation expense of $661,000 and $325,000, respectively, related to stock option grants
to employees, directors and consultants. The increase in general and administrative stock-based compensation expense for the year ended
April 30, 2026, was a result of the vesting of newly granted stock options.
Marketing Fees
During the years ended April
30, 2026 and 2025, we incurred marketing fees of $425,000 and $347,000, respectively, which was primarily expenses related to the marketing
and branding of our company.
Current and Deferred Income Taxes
As of April 30, 2026 and 2025,
we had deferred tax assets totaling $15.4 million and $15.3 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, 2026 and 2025.
Liquidity and Capital Resources
The accompanying financial
statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred recurring net losses
and operations have not provided sufficient cash flows. We believe that we will continue to incur operating and net losses each quarter
until at least the time we begin significant deliveries of our products. We believe our current cash on hand is insufficient to fund our
planned operations through one year after the date the 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 audited financial statements are issued.
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, 2026, we had cash of $711,000 and an accumulated deficit of $67.3 million. We have incurred recurring losses
and reported a loss for the year ended April 30, 2026 totaling $8.8 million. In the past, we have financed our operations principally
through sales of equity securities and debt instruments.
We will need to obtain substantial
additional funding in the future for our clinical development activities and continuing operations. If we are unable to raise capital
when needed or on favorable terms, we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization
efforts. Our future capital requirements will depend on many factors, including:
· successful enrollment in and completion of clinical trials;
- 51 -
· our ability to establish agreements with third-party manufacturers for clinical supply for our clinical
trials and, if our product candidates are approved, commercial manufacturing;
· our ability to maintain our current research and development programs and establish new research and development
programs;
· addition and retention of key research and development personnel;
· our efforts to enhance operational, financial, and information management systems, and hire additional
personnel, including personnel to support development of our product candidates;
· negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter
and performing our obligations in such collaborations;
· the timing and amount of milestone and other payments we may receive under our collaboration arrangements;
· our eventual commercialization plans for our product candidates;
· the costs involved in prosecuting, defending, and enforcing patent claims and other intellectual property
claims; and
· the costs and timing of regulatory approvals.
A change in the outcome of
any of these or other variables with respect to the development of any of our product candidates could significantly change the costs
and timing associated with the development of that product candidate. Furthermore, our operating plans may change in the future, and we
may need additional funds to meet operational needs and capital requirements associated with such operating plans.
At-the-Market Offering
See Note 9 – Equity
Transactions in the notes to the financial statements for a description of our fundraising activities.
Cash Flows
The following table summarizes our cash flows for
the years ended April 30, 2026 and 2025:
For the Years Ended April 30,
2026
2025
Net cash provided by (used in):
Operating activities
$ (8,067,813 )
$ (6,568,186 )
Investing activities
-
(300,000 )
Financing activities
4,829,844
10,440,796
Net (decrease) increase in cash and cash equivalents
$ (3,237,969 )
$ 3,572,610
Operating Activities
During the year ended April
30, 2026, net cash used in operating activities was $8.1 million. This consisted primarily of a net loss of $8.8 million and a decrease
in our net operating assets and liabilities of $114,000, partially offset by stock-based compensation of $708,000 and depreciation of
$110,000. The decrease in our net operating assets and liabilities was primarily due to an increase in accounts payable and accrued liabilities
and an increase in prepaid expenses.
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 an increase in prepaid expenses and a decrease in accounts payable.
Investing Activities
During the year ended April
30, 2026, there were no investing activities. During the year ended April 30, 2025, net cash used in investing activities was $300,000
for the purchase of equipment and machinery used in our AL001 Phase II clinical trials.
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Financing Activities
During the year ended April
30, 2026, net cash provided by financing activities was $4.1 million from the sale of convertible preferred stock and $800,000 from proceeds
from an “at-the-market” offering (“ATM Offering”).
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 ATM Offering.
See Note 9 – Equity
Transactions in the notes to the financial statements for a description of our financing activities.
Contractual Obligations
See the “Intellectual Property and Licensing
Agreements” sub-section under Item 1. Business of this Annual Report.
Recent Accounting Standards
For information about recent
accounting pronouncements that may impact our financial statements, please refer to Note 3 of Notes to Financial Statements under the
heading “Recent Accounting Standards.”
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Because we are a smaller reporting
company, this section is not applicable.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements required
by this Item 8 are included in this Annual Report following Item 16 hereof. As a smaller reporting company, we are not required to provide
supplementary financial information.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
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