ALZN

As of April 30, 2026, we had $711,000 in cash and cash equivalents.
In particular, we need additional funds to allow us to fund Phase II clinical trials for AL001 in Alzheimer’s, BD, MDD and PTSD and complete the Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia of the Alzheimer’s type.
We will need to raise substantial additional capital to complete the development and commercialization of each of those product candidates, which additional capital, if available on reasonable terms if at all, may be raised through the sale of our common stock or other securities or through the entering into of alternative strategic transactions, which could cause our stockholders to incur substantial dilution.
Our future capital requirements will depend on many factors, including: • the initiation, progress, timing, costs and results of our planned clinical trials for our product candidates; • the number and scope of indications we decide to pursue for product development; • the cost, timing and outcome of regulatory review of any NDA or BLA we may submit for our product candidates; • the costs and timing of manufacturing for our product candidates, if approved; • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our product candidates; • the costs associated with being a public company; • our ability to enter into partnerships or otherwise monetize our pipeline through strategic transactions on a timely basis, on terms that are favorable to us, or at all; • the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; - 22 - • the extent to which we acquire or in-license other product candidates and technologies; and • the cost associated with commercializing our product candidates, if any are approved for commercial sale.
Our future commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for sale for at least the next several years, if ever.
Our independent registered public accounting firm has issued a report on our financial statements for the year ended April 30, 2026, that contains an emphasis of a matter paragraph expressing substantial doubt about our ability to continue as a going concern due to insufficient capital for us to fund our operations.
We have initiated clinical trials for our AL001 and ALZN002 programs.
Risks Related to Our Product Candidates We have both operational and financial milestones that must be met to maintain the licensing rights to our current technology and intellectual property from the Licensor.
There are certain license fees and milestone payments required to be paid by us to the Licensor pursuant to the terms of license agreements we have entered into with the Licensor.
The license agreement for ALZN002 requires us to pay royalty payments of 4% on net sales of products developed from the licensed technology for ALZN002, while the license agreements for AL001 require that we pay combined royalty payments of 4.5% on net sales of products developed from the licensed technology for AL001.
As an additional licensing fee for the license of ALZN002, the Licensor received 2,668 shares of our common stock.
As an additional licensing fee for the license of the AL001 technologies, the Licensor received 1,650 shares of our common stock.
Minimum royalties required under the 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.
Minimum royalties required 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.
Minimum royalties required under the 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.
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: - 23 - Original AL001 Licenses: Payment Due Date $ 50,000* Pre-IND Meeting - Completed September 2019 $ 65,000* IND application filing - Completed June 2021 $ 190,000* Upon first dosing of patient in a clinical trial - Completed December 2021 $ 500,000* Upon completion of first clinical trial - Completed March 2022 $ 1,250,000 Upon first patient treated in a Phase III clinical trial $ 10,000,000 Upon FDA NDA approval * Milestone met and completed ALZN002 License: Payment Due Date $ 50,000* Upon IND application - Completed January 2022 $ 50,000 Upon first dosing of patient in first Phase I clinical trial $ 500,000 Upon completion of first Phase IIB clinical trial $ 1,000,000 Upon first patient treated in a Phase III clinical trial $ 10,000,000 Upon first commercial sale * Milestone met and completed Additional AL001 Licenses: Payment Due Date $ 2,000,000 Upon first patient treated in a Phase III clinical trial $ 16,000,000 First commercial sale These AL001 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.
If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with the Licensor, we could lose license rights that are critical to our business.
We are a party to license agreements with the Licensor and expect to enter into additional license agreements in the future.
If we fail to comply with our obligations under these agreements, or we are subject to a bankruptcy, we may be required to make certain payments to the Licensor, we may lose the exclusivity of our license, or the Licensor may have the right to terminate the license, in which event we would not be able to develop or market products covered by the license and would be forced to cease our operations.
If the Licensor were to terminate a license agreement for whatever reason, it would materially and adversely affect our business, financial position and future prospects and you would likely lose the entirety of your investment in us.
In some cases, patent prosecution of our licensed technology is controlled solely by the Licensor.
Disputes may arise regarding intellectual property subject to a licensing agreement, including but not limited to: • the scope of rights granted under the license agreement and other interpretation-related issues; - 24 - • the extent to which our technology and processes infringe on intellectual property of the Licensor that is not subject to the licensing agreement; • the sublicensing of patent and other rights; • our diligence obligations under each of the license agreements and what activities satisfy those diligence obligations; • the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our collaborators; and • the priority of invention of patented technology.
The development and commercial success of our product candidates will depend on a number of factors, including, without limitation, the following: • our timely initiation and successful completion of preclinical studies and clinical trials for AL001 or ALZN002; • our demonstration to the satisfaction of the FDA and comparable regulatory bodies of the safety and efficacy of AL001 or ALZN002, as well as to obtain regulatory and marketing approval for AL001 or ALZN002 in the United States, Europe, the United Kingdom and elsewhere; • our continued compliance with all clinical and regulatory requirements applicable to AL001 and ALZN002; • our maintenance of an acceptable safety profile of AL001 and ALZN002 following regulatory approval; • competition with other treatments; • our creation, maintenance and protection of our intellectual property portfolio, including patents and trade secrets, and regulatory exclusivity for AL001 and ALZN002; • the effectiveness of our and our eventual partners’ marketing, sales and distribution strategy and operations; • the ability of our third-party manufacturers to manufacture supplies of our product and product candidates and to develop, validate and maintain commercially viable manufacturing processes; • our ability to launch commercial sales of AL001 or ALZN002 following regulatory approval, whether alone or in collaboration with others; and • the acceptance of AL001 and ALZN002 by physicians, healthcare payers, patients and the medical community.
Our failure in any of the above factors, or in successfully commercializing AL001 or ALZN002 on a timely basis, could have a material adverse effect on our business, results of operations and financial condition, and the value of your investment could substantially decline.
AL001 and ALZN002 may not achieve market acceptance, which would significantly limit our ability to generate revenue.
Market acceptance of any product candidate depends on a number of factors, including but not limited to: - 25 - • the indication and warnings approved by regulatory authorities in the product label; • continued demonstration to the FDA of safety and efficacy in commercial use; • physicians’ willingness to prescribe the product; • reimbursement from third-party payers such as government healthcare systems and insurance companies; • the price of the product; • the nature of any post-approval risk management plans mandated by regulatory authorities; • competition; and • the effectiveness of marketing and distribution support.
See also “Risks Related to Development and Regulatory Approval of Our Product.” The regulatory approval process is uncertain, requires us to utilize significant financial, physical and human resources, and may prevent us or our future commercial partners from obtaining approvals for the commercialization of some or all of our product candidates. - 26 - Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of AL001 or ALZN002, or limit the scope of any approved label or market acceptance.
A current trend in the U.S. healthcare industry, as well as in other countries around the world, is toward cost containment.
Third-party payers, such as government programs, including Medicare in the United States, and private healthcare insurers, carefully review and have increasingly been challenging the coverage of, and prices charged for, medical products and services.
Many third-party payers limit coverage of or reimbursement for newly-approved healthcare products.
Cost-control initiatives could decrease the price we or our partners establish for products, which could result in lower product revenue and profitability.
Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals must be obtained on a country-by-country basis.
If countries set prices that are not sufficient to allow us or our partners to generate a profit, our partners may refuse to launch the product in such countries or withdraw the product from the market, which would adversely affect our sales and profitability and could materially and adversely affect our business, results of operations and financial condition. - 27 - Risks Related to Development and Regulatory Approval of Our Drug Candidates We rely on third parties to conduct our preclinical and clinical studies and perform other tasks for us.
If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our medicines and drug candidates and our business could be substantially harmed.
We have relied upon and plan to continue to rely upon third-party CROs to monitor and manage data and provide other services for our ongoing preclinical and clinical programs.
We rely on these parties for execution of our preclinical and clinical studies, and control only certain aspects of their activities.
Nevertheless, we are responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities.
We, our CROs for our clinical programs and our clinical investigators are required to comply with GCPs, which are regulations and guidelines enforced by the FDA for all of our drug candidates in clinical development.
The FDA enforces these regulations through periodic inspections of study sponsors, principal investigators, study sites and other contractors.
If we or any of our CROs or clinical investigators fail to comply with applicable regulations, the clinical data generated in our clinical studies may be deemed unreliable and the FDA may require us to perform additional clinical studies before approving our marketing applications.

and 89 more.

Gone since FY2025

As of April 30, 2025, we had $3.9 million in cash and cash equivalents.
In February 2025, we entered into a transaction with an investor that resulted in raising an additional $4.0 million subsequent to year end.
In particular, we need additional funds to allow us to fund Phase II clinical trials for AL001 in Alzheimer’s, BD, MDD and PTSD and to complete the on-going Phase I/IIA clinical trial for ALZN002 to treat mild to moderate dementia of the Alzheimer’s type.
We will need to raise substantial additional capital to complete the development and commercialization of each of those product candidates, which additional capital, if available on reasonable terms if at all, may be raised through the sale of our common stock or other securities or through the entering into of alternative strategic transactions, or cause our stockholders to incur substantial dilution.
Our future capital requirements will depend on many factors, including: • the initiation, progress, timing, costs and results of our planned clinical trials for our product candidates; • the number and scope of indications we decide to pursue for product development; • the cost, timing and outcome of regulatory review of any NDA or BLA we may submit for our product candidates; • the costs and timing of manufacturing for our product candidates, if approved; • the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; • our efforts to enhance operational systems and our ability to attract, hire and retain qualified personnel, including personnel to support the development of our product candidates; • the costs associated with being a public company; • our ability to enter into partnerships or otherwise monetize our pipeline through strategic transactions on a timely basis, on terms that are favorable to us, or at all; • the terms and timing of establishing and maintaining collaborations, licenses and other similar arrangements; - 21 - • the extent to which we acquire or in-license other product candidates and technologies; and • the cost associated with commercializing our product candidates, if any are approved for commercial sale.
Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for sale for at least the next several years, if ever.
Our independent registered public accounting firm has issued a going concern opinion on our financial statements for the year ended April 30, 2025, expressing substantial doubt that we can continue as an ongoing business due to insufficient capital for us to fund our operations.
We have recently initiated clinical trials for our AL001 and ALZN002 programs.
We have a limited operating history on which to judge our business prospects and management.
We were incorporated in February 2016 and commenced operations shortly thereafter.
We have a limited operating history upon which to base an evaluation of our business and prospects.
Operating results for future periods are subject to numerous uncertainties and we cannot assure you that we will achieve or sustain profitability.
Our prospects must be considered in light of the risks encountered by companies in the early stage of development, particularly companies in new and rapidly evolving markets with long periods of time before they can ever generate revenue, and then subsequently achieve profitability, if ever.
Future operating results will depend upon many factors, including our success in attracting and retaining motivated and qualified personnel, our ability to establish short term credit lines or obtain financing from other sources, our ability to develop and market new products or control costs, and general economic conditions.
We cannot assure you that we will successfully address any of these contingencies.
Risks Related to Our Product Candidates We have both operational and financial milestones that must be met to maintain the licensing rights to our current technology and intellectual property from the Licensor. - 22 - There are certain license fees and milestone payments required to be paid by us to the Licensor, pursuant to the terms of license agreements we have entered into with the Licensor.
The license agreements for ALZN002 require us to pay royalty payments of 4% on net sales of products developed from the licensed technology for ALZN002 while the license agreements for AL001 require that we pay combined royalty payments of 4.5% on net sales of products developed from the licensed technology for AL001.
As an additional licensing fee for the license of ALZN002, the Licensor received 24,012 shares of our common stock.
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 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.
Minimum royalties for ALZN002 are $20,000 on the first anniversary of the first commercial sale, $40,000 on the second anniversary 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.
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 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 .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: Original AL001 Licenses: Payment Due Date $ 50,000* Pre-IND Meeting - Completed September 2019 $ 65,000* IND application filing - Completed June 2021 $ 190,000* Upon first dosing of patient in a clinical trial - Completed December 2021 $ 500,000* Upon completion of first clinical trial - Completed March 2022 $ 1,250,000 Upon first patient treated in a Phase III clinical trial $ 10,000,000 Upon FDA NDA approval * Milestone met and completed ALZN002 License: Payment Due Date $ 50,000* Upon IND application - Completed January 2022 $ 50,000 Upon first dosing of patient in first Phase I clinical trial $ 500,000 Upon completion of first Phase IIB clinical trial $ 1,000,000 Upon first patient treated in a Phase III clinical trial $ 10,000,000 Upon first commercial sale * Milestone met and completed Additional AL001 Licenses: Payment Due Date $ 2,000,000 Upon first patient treated in a Phase III clinical trial $ 16,000,000 First commercial sale These AL001 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.
If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with the Licensor, we could lose license rights that are important to our business.
We are a party to these license agreements with the Licensor and expect to enter into additional license agreements in the future.
If we fail to comply with our obligations under these agreements, or we are subject to a bankruptcy, we may be required to make certain payments to the Licensor, we may lose the exclusivity of our license, or the Licensor may have the right to terminate the license, in which event we would not be able to develop or market products covered by the license and would be forced to wind down our operations.
If the Licensor were to terminate a license agreement for whatever reason, it would materially and adversely affect our business, financial position and future prospects and you would likely lose the entirety of your investment in us. - 23 - In some cases, patent prosecution of our licensed technology is controlled solely by the Licensor.
Disputes may arise regarding intellectual property subject to a licensing agreement, including but not limited to: • the scope of rights granted under the license agreement and other interpretation-related issues; • the extent to which our technology and processes infringe on intellectual property of the Licensor that is not subject to the licensing agreement; • the sublicensing of patent and other rights; • our diligence obligations under each of the license agreements and what activities satisfy those diligence obligations; • the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and us and our collaborators; and • the priority of invention of patented technology.
The development and commercial success of our product will depend on a number of factors, including, without limitation, the following: • our timely initiation and successful completion of preclinical studies and clinical trials for AL001 or ALZN002; • our demonstration to the satisfaction of the FDA and comparable regulatory bodies of the safety and efficacy of AL001 or ALZN002, as well as to obtain regulatory and marketing approval for AL001 or ALZN002 in the United States, Europe, the United Kingdom and elsewhere; • our continued compliance with all clinical and regulatory requirements applicable to AL001 and ALZN002; • our maintenance of an acceptable safety profile of AL001 and ALZN002 following regulatory approval; • competition with other treatments; • our creation, maintenance and protection of our intellectual property portfolio, including patents and trade secrets, and regulatory exclusivity for AL001 and ALZN002; • the effectiveness of our and our eventual partners’ marketing, sales and distribution strategy and operations; • the ability of our third-party manufacturers to manufacture supplies of our product and product candidates and to develop, validate and maintain commercially viable manufacturing processes; • our ability to launch commercial sales of AL001 or ALZN002 following regulatory approval, whether alone or in collaboration with others; and • the acceptance of AL001 and ALZN002 by physicians, health care payers, patients and the medical community.
Our failure in any of the above factors, or in successfully commercializing AL001 or ALZN002 on a timely basis, could have a material adverse effect on our business, results of operations and financial condition, and the value of your investment could substantially decline. - 24 - AL001 and ALZN002 may not achieve market acceptance, which would significantly limit our ability to generate revenue.
Market acceptance of any product candidate depends on a number of factors, including but not limited to: • the indication and warnings approved by regulatory authorities in the product label; • continued demonstration to the FDA of safety and efficacy in commercial use; • physicians’ willingness to prescribe the product; • reimbursement from third-party payers such as government health care systems and insurance companies; • the price of the product; • the nature of any post-approval risk management plans mandated by regulatory authorities; • competition; and • the effectiveness of marketing and distribution support.
See also “Risks Related to Development and Regulatory Approval of Our Product.” The regulatory approval process is uncertain, requires us to utilize significant financial, physical and human resources, and may prevent us or our future commercial partners from obtaining approvals for the commercialization of some or all of our product candidates. - 25 - Serious adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of AL001 or ALZN002, or limit the scope of any approved label or market acceptance.
A current trend in the U.S. health care industry, as well as in other countries around the world, is toward cost containment.
Third-party payers, such as government programs, including Medicare in the United States, and private health care insurers, carefully review and have increasingly been challenging the coverage of, and prices charged for, medical products and services.
Many third-party payers limit coverage of or reimbursement for newly-approved health care products.
Cost-control initiatives could decrease the price we or our partners establish for products, which could result in lower product revenue and profitability. - 26 - Reimbursement systems in international markets vary significantly by country and by region, and reimbursement approvals must be obtained on a country-by-country basis.
If countries set prices that are not sufficient to allow us or our partners to generate a profit, our partners may refuse to launch the product in such countries or withdraw the product from the market, which would adversely affect our sales and profitability and could materially and adversely affect our business, results of operations and financial condition.
Risks Related to Development and Regulatory Approval of Our Drug Candidates The regulatory approval process is uncertain, requires us to utilize significant resources, and may prevent us or our future commercial partners from obtaining approvals for the commercialization of AL001 or ALZN002.
The process required by the FDA and most foreign regulatory authorities before human health care pharmaceuticals may be marketed generally involves nonclinical laboratory and, in some cases, animal tests; submission of an IND, which must become effective before clinical trials may begin; adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed drug for its intended use or uses; pre-approval inspection of manufacturing facilities and clinical trial sites; and FDA approval of an NDA or BLA, which must occur before a drug can be marketed or sold.
If our product or any of our future product candidates fails to demonstrate safety and efficacy in our studies, or for any other reason does not gain regulatory approval, our business and results of operations will be materially and adversely harmed.
In addition, separate regulatory approvals are required in order to market any product in many jurisdictions, including the United States, the United Kingdom, European Economic Area, which consists of the 27 Member States (known as the “EU Member States”) of the European Union plus Norway, Iceland and Liechtenstein, and others.

and 115 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2025 ↗, FY2026 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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