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Item 1A. Risk Factors

2026-07-22 compared with 2025-07-22 · 331 added, 399 removed, 1151 unchanged (39% of the section changed)

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Clinical Development and Financial Condition

We need to obtain

substantial additional funding to complete the development and any commercialization of AL001 and ALZN002.

If we are unable to raise this

capital when needed, we may be forced to delay, reduce or eliminate our research and development programs and other operations.

expect our expenses to increase substantially during the next few years.

The development of biotechnology product candidates is capital

As we conduct non-clinical research and clinical development of our product candidates,

we will need substantial additional funds to maintain and expand our capabilities in a variety of areas including discovery and non-clinical

research, clinical development, regulatory affairs, product development, product quality assurance, and pharmacovigilance.

if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses for marketing,

sales, manufacturing and distribution.

Some of those commercialization investments may be made at-risk in advance of receiving an approval.

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.

Based on our current operating plan, we believe that this

funding will not be sufficient to fund our operations for the next twelve months.

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.

However, changing circumstances or inaccurate estimates

by us may cause us to use capital significantly faster than we currently anticipate, and we may need to spend more money than currently

expected because of circumstances beyond our control.

For example, our ongoing clinical trial for ALZN002 or our planned clinical trials

for AL001 may encounter technical, enrollment or other issues that could cause our development costs to increase more than we expect.

We will not have sufficient funds to complete any of these planned or ongoing clinical trials or the clinical development of either AL001

or ALZN002 through regulatory approval.

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.

future capital requirements will depend on many factors, including:

We need to obtain substantial additional

funding to complete the development and any commercialization of AL001 and ALZN002.

If we are unable to raise this capital when needed,

we may be forced to delay, reduce or eliminate our research and development programs and other operations.

We expect our expenses to

increase substantially during the next few years.

The development of biotechnology product candidates is capital intensive.

As we conduct

non-clinical research and clinical development of our product candidates, we will need substantial additional funds to maintain and expand

our capabilities in a variety of areas including discovery and non-clinical research, clinical development, regulatory affairs, product

development, product quality assurance, and pharmacovigilance.

In addition, if we obtain marketing approval for any of our product candidates,

we expect to incur significant commercialization expenses for marketing, sales, manufacturing and distribution.

Some of those commercialization

investments may be made at-risk in advance of receiving an approval.

As of April 30, 2026, we had

$711,000 in cash and cash equivalents.

Based on our current operating plan, we believe that this funding will not be sufficient to fund

our operations for the next twelve months.

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.

However, changing circumstances or inaccurate estimates by us may cause us to use capital significantly faster

than we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control.

For example, our ongoing clinical trial for ALZN002 or our planned clinical trials for AL001 may encounter technical, enrollment or other

issues that could cause our development costs to increase more than we expect.

We will not have sufficient funds to complete any of these

planned or ongoing clinical trials or the clinical development of either AL001 or ALZN002 through regulatory approval.

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;

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• 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;

• 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;

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• 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

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.

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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.

Our financial statements

do not include any adjustments that may result from the outcome of this uncertainty.

If we are unable to successfully raise additional

capital, we will need to create and implement alternate operational plans to continue as a going concern, and investors or other financing

sources may be unwilling to provide additional funding to us on commercially reasonable terms or at all.

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.

Our financial statements do not include any adjustments that may result from the outcome of this uncertainty.

we are unable to successfully raise additional capital, we will need to create and implement alternate operational plans to continue as

a going concern, and investors or other financing sources may be unwilling to provide additional funding to us on commercially reasonable

terms or at all.

We are at an early stage of clinical development

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We are a clinical-stage biopharmaceutical

We have recently initiated clinical trials for our AL001 and ALZN002 programs.

To date, we have not initiated or completed a

pivotal clinical trial, obtained marketing approval for any product candidates, manufactured a commercial scale product or arranged for

a third party to do so on our behalf, or conducted sales and marketing activities necessary for successful product commercialization.

Our ability to generate revenue depends heavily on, among other developments:

We have initiated clinical trials for our AL001 and ALZN002 programs.

To date, we have not initiated or completed a pivotal clinical

trial, obtained marketing approval for any product candidates, manufactured a commercial scale product or arranged for a third party to

do so on our behalf, or conducted sales and marketing activities necessary for successful product commercialization.

Our ability to generate

revenue depends heavily on, among other developments:

• demonstration to the satisfaction of the FDA and comparable regulatory bodies that AL001 and ALZN002 are

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will not become profitable, and we may be unable to continue our operations.

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

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

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with the Licensor.

The license agreements for ALZN002 require us to pay royalty payments of 4% on net sales of products developed from

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

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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:

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:

Original AL001 Licenses:

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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

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.

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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.

or any future licensor may take any of these actions, including terminating a license agreement.

Additionally, the milestone and other

payments associated with these licenses will make it less profitable for us to develop our product candidates.

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.

we would not be able to develop or market products covered by the license and would be forced to cease our operations.

The Licensor or

any future licensor may take any of these actions, including terminating a license agreement.

Additionally, the milestone and other payments

associated with these licenses will make it less profitable for us to develop our product candidates.

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

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The development and commercial

success of our product will depend on a number of factors, including, without limitation, the following:

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

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or in collaboration with others;

• the acceptance of AL001 and ALZN002 by physicians, health care payers, patients and the medical community.

• the acceptance of AL001 and ALZN002 by physicians, healthcare payers, patients and the medical community.

Many of these factors are

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• physicians’ willingness to prescribe the product;

• reimbursement from third-party payers such as government health care systems and insurance companies;

• reimbursement from third-party payers such as government healthcare systems and insurance companies;

• the price of the product;

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partners can begin commercial manufacture of AL001 and ALZN002 or any other product candidate that we may develop in the future, we must

obtain FDA regulatory approval for the product, which requires a successful FDA inspection of our manufacturing facilities (or those we

contract with) and the development of quality systems, among other requirements.

Even if we successfully pass an FDA Pre-Approval Inspection

of any manufacturing facilities we may establish or contract with, our pharmaceutical facilities would be subject to unannounced inspection

by the FDA and foreign regulatory authorities to ensure ongoing manufacturing compliance, even after product approval.

Due to the complexity

of the processes that we anticipate will eventually be used to manufacture AL001 and ALZN002, we may be unable to pass federal, state

or international regulatory inspections in a cost-effective manner, whether initially or at any time thereafter.

If we are unable to comply

with manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure of any approved products,

or legal actions such as injunctions or criminal or civil prosecution.

These possible sanctions could materially and adversely affect

our business, results of operations and financial condition.

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

obtain FDA regulatory approval for the product, which requires a successful FDA inspection of our manufacturing facilities (or those

we contract with) and the development of quality systems, among other requirements.

Even if we successfully pass an FDA Pre-Approval

Inspection of any manufacturing facilities we may establish or contract with, our pharmaceutical facilities would be subject to unannounced

inspection by the FDA and foreign regulatory authorities to ensure ongoing manufacturing compliance, even after product approval.

to the complexity of the processes that we anticipate will eventually be used to manufacture AL001 and ALZN002, we may be unable to pass

federal, state or international regulatory inspections in a cost-effective manner, whether initially or at any time thereafter.

are unable to comply with manufacturing regulations, we may be subject to fines, unanticipated compliance expenses, recall or seizure

of any approved products, or legal actions such as injunctions or criminal or civil prosecution.

These possible sanctions could materially

and adversely affect our business, results of operations and financial condition.

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.

Serious adverse events or other safety risks

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A current trend in the U.S.

health care industry, as well as in other countries around the world, is toward cost containment.

healthcare industry, as well as in other countries around the world, is toward cost containment.

Large public and private payers, managed

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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

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 health care

Reimbursement rates and coverage from private health insurance companies vary depending on the company, the insurance plan and

other factors.

Cost-control initiatives could decrease the price we or our partners establish for products, which could result in lower

product revenue and profitability.

Many third-party payers limit coverage of or reimbursement for newly-approved healthcare products.

Reimbursement rates and coverage from private health insurance companies vary depending on the company, the insurance plan and other factors.

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

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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

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.

In addition, our pivotal clinical trials

must be conducted with drug product produced under GMP regulations.

We cannot assure you that upon inspection by a given regulatory authority,

such regulatory authority will determine that any of our clinical studies comply with GCP regulations.

In addition, our clinical studies

must be conducted with product candidates which are produced under cGMP regulations.

Our failure to comply with these regulations may

require us to repeat clinical studies, which would delay the regulatory approval process.

We could also be subject to government investigations

and enforcement actions.

If any of our relationships

with these third-party CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially

reasonable terms.

For example, in February 2024, Biorasi, our CRO for our Phase I/IIA clinical trial for ALZN002 to treat mild to moderate

dementia of the Alzheimer’s type, terminated our contract with it.

While we are currently pursuing the engagement of a replacement

CRO on this clinical study, as a result of the novel nature of the clinical study, we have been unable to find a suitable CRO with the

requisite experience and expertise to manage the study.

In addition, our CROs are

not our employees, and except for remedies available to us under our agreements with such CROs, we cannot control whether or not they

devote sufficient time and resources to our ongoing clinical and nonclinical programs.

If CROs do not successfully carry out their contractual

duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they

or our clinical investigators obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or

for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for

or successfully commercialize our drug candidates.

As a result, our results of operations and the commercial prospects for our drug candidates

would be harmed, our costs could increase and our ability to generate revenues could be delayed.

Switching or adding additional

CROs involves additional cost and delays, which can materially influence our ability to meet our desired clinical development timelines.

There can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will

not have a material adverse effect on our business, financial condition and prospects.

The regulatory approval process is uncertain,

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all applicable laws and regulations, the FDA may still determine that our clinical data are insufficient for final approval of an NDA

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;

The process required by the FDA and most foreign regulatory authorities before human healthcare pharmaceuticals may be marketed

generally involves nonclinical laboratory and, in some cases, animal testing;

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.

and FDA approval of an NDA

or BLA, which must occur before a drug can be marketed or sold, as discussed above.

Regulatory approval of an

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materially and adversely affect our business, results of operations or financial condition.

Most attempts at

drug approval for Alzheimer’s have failed.

billions of dollars invested by the NIH and the biopharmaceutical industry in research programs to develop novel therapeutics for Alzheimer’s,

the FDA has only approved three new drugs for Alzheimer’s since 2003;

in June 2021, aducanumab

(Biogen, Inc) received approval from the FDA for the treatment of Alzheimer’s using the accelerated approval pathway;

in July 2023,

Leqembi (Eisai) received full approval by the FDA for treatment of Alzheimer’s;

and in July 2024, Kisunla (Eli Lilly) received full

approval by the FDA for treatment of Alzheimer’s.

Since 2003, many new types and classes of drugs have been developed and tested

in Alzheimer’s, including monoclonal antibodies, gamma secretase modulators and inhibitors, β-site amyloid precursor protein

cleaving enzyme inhibitors, receptor for advanced glycation end-products inhibitors, nicotinic partial agonists and allosteric modulators,

serotonin subtype receptor antagonists, and others.

Except for Biogen’s, Eisai’s and Eli Lilly’s approvals, referred

to above, virtually all of these scientific programs have failed in clinical testing.

Most attempts at drug approval for Alzheimer’s

Despite billions of dollars

invested by the NIH and the biopharmaceutical industry in research programs to develop novel therapeutics for Alzheimer’s, the FDA

has approved only four new drugs for Alzheimer’s since 2003;

in June 2021, aducanumab (Biogen, Inc) received approval from the FDA

for the treatment of Alzheimer’s using the accelerated approval pathway;

in July 2023, Leqembi (Eisai) received full approval by

the FDA for treatment of Alzheimer’s;

in July 2024, Kisunla (Eli Lilly) received full approval by the FDA for treatment of Alzheimer’s

and in April 2026, Auvelity (Axsome Therapeutics) received full approval by the FDA for treatment of agitation associated with Alzheimer’s

Since 2003, many new types and classes of drugs have been developed and tested in Alzheimer’s, including monoclonal antibodies,

gamma secretase modulators and inhibitors, β-site amyloid precursor protein cleaving enzyme inhibitors, receptor for advanced glycation

end-products inhibitors, nicotinic partial agonists and allosteric modulators, serotonin subtype receptor antagonists, and others.

for Biogen’s, Eisai’s Eli Lilly’s and Axsome Therapeutics’ approvals referred to above, virtually all of these

scientific programs have failed in clinical testing.

Clinical trials for AL001 or ALZN002 can

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REMS elements can

include medication guides, communication plans for health care professionals, and elements to assure safe use (“ETASU”).

include medication guides, communication plans for healthcare professionals, and elements to assure safe use (“ETASU”).

can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances,

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and abuse” laws, we may be subject to criminal and civil penalties and/or be suspended or excluded from participation in government-run

health care programs, which may adversely affect our business, financial condition and results of operations.

healthcare programs, which may adversely affect our business, financial condition and results of operations.

If we are successful in obtaining

marketing approval for our products in the United States and elsewhere, we will be subject to various health care “fraud and abuse”

laws, including anti-kickback laws, false claims laws and other laws intended to reduce fraud and abuse in government-run health care

programs, which could materially and adversely affect us, particularly upon successful commercialization of our products in the United

For example, the federal Anti-Kickback Statute makes it illegal for any person, including a prescription drug manufacturer (or

a party acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the

referral of business, including the purchase, order or prescription of a particular drug for which payment may be made under a U.S.

care program such as Medicare or Medicaid.

federal government regulations, some arrangements, known as safe harbors, are deemed

not to violate the Anti-Kickback Statute.

Compliance with every element of a safe harbor regulation is required for the arrangement to

be protected.

marketing approval for our products in the United States and elsewhere, we will be subject to various healthcare “fraud and abuse”

laws, including anti-kickback laws, false claims laws and other laws intended to reduce fraud and abuse in government-run healthcare programs,

which could materially and adversely affect us, particularly upon successful commercialization of our products in the United States.

example, the federal Anti-Kickback Statute makes it illegal for any person, including a prescription drug manufacturer (or a party acting

on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration that is intended to induce the referral of

business, including the purchase, order or prescription of a particular drug for which payment may be made under a U.S.

healthcare program

such as Medicare or Medicaid.

federal government regulations, some arrangements, known as safe harbors, are deemed not to violate

the Anti-Kickback Statute.

Compliance with every element of a safe harbor regulation is required for the arrangement to be protected.

However, arrangements that do not comply with a safe harbor are not per se illegal.

Instead, they will be analyzed on a

case-by-case basis.

Although we intend to seek to structure our business arrangements in compliance with all applicable requirements,

these laws are broadly written, and it is often difficult to determine precisely how the law will be applied in specific circumstances.

Accordingly, it is possible that our practices may be challenged under the Anti-Kickback Statute and similar laws in other jurisdictions.

Instead, they will be analyzed on a case-by-case basis.

Although we intend to seek to structure our business arrangements in compliance with all applicable requirements, these laws are broadly

written, and it is often difficult to determine precisely how the law will be applied in specific circumstances.

Accordingly, it is possible

that our practices may be challenged under the Anti-Kickback Statute and similar laws in other jurisdictions.

Further, false claims laws

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promotion of pharmaceutical products or the payment of kickbacks by pharmaceutical providers has resulted in the submission of false claims

to governmental health care programs.

to governmental healthcare programs.

Under laws such as the Health Insurance Portability and Accountability Act of 1996 in the United

States, we are prohibited from knowingly and willfully executing a scheme to defraud any health care benefit program, including private

States, we are prohibited from knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private

payers, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or

fraudulent statement in connection with the delivery of or payment for health care benefits, items or services.

fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

Violations of fraud and

abuse laws may be punishable by criminal and/or civil sanctions, including fines and/or exclusion or suspension from government-run health

care programs such as Medicare and Medicaid and debarment from contracting with the U.S.

abuse laws may be punishable by criminal and/or civil sanctions, including fines and/or exclusion or suspension from government-run healthcare

programs such as Medicare and Medicaid and debarment from contracting with the U.S.

and other governments.

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States have adopted fraud and abuse laws similar to their federal counterparts, including laws similar to the Anti-Kickback Statute, some

of which apply to the referral of patients for health care services reimbursed by any source, not just governmental payers.

of which apply to the referral of patients for healthcare services reimbursed by any source, not just governmental payers.

California and some other states in the United States have passed laws that require pharmaceutical companies to comply with the April 2003

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If we are found in violation of one of these laws, we could be required to pay a penalty and

could be suspended or excluded from participation in certain government-run health care programs, and our business, results of operations

could be suspended or excluded from participation in certain government-run healthcare programs, and our business, results of operations

and financial condition may be materially and adversely affected.

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Katzoff, our Chief Financial

Officer, Kenneth S.

Cragun, our Senior Vice President of Finance and Henry Nisser, our Executive Vice President and General Counsel.

loss of services of any of these individuals could delay or prevent the successful development of our current or future product pipeline,

completion of our planned development efforts or the commercialization of AL001 or ALZN002.

It is possible that current or former employees

of ours could put forward claims for an alleged right to our patents and demand compensation therefor.

If one or more of the key personnel

were to leave us and engage in competing operations, our business, results of operations and financial condition could be materially and

adversely affected.

Officer, and Henry Nisser, our Executive Vice President and General Counsel.

The loss of services of any of these individuals could delay

or prevent the successful development of our current or future product pipeline, completion of our planned development efforts or the

commercialization of AL001 or ALZN002.

It is possible that current or former employees of ours could put forward claims for an alleged

right to our patents and demand compensation therefor.

If one or more of the key personnel were to leave us and engage in competing operations,

our business, results of operations and financial condition could be materially and adversely affected.

We expect to face substantial competition,

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are targeting with AL001 and ALZN002, we also face potential competition from other drug candidates in development by other companies.

Our potential competitors include, without limitation, large health care companies, such as AbbVie, Biogen Inc., Eisai Co., Ltd., Takeda

Pharmaceuticals, Bristol Myers Squibb, Pfizer Inc., Merck & Co., Inc., Sanofi S.A., Eli Lilly and Company, Bayer AG, Novartis AG,

Johnson and Johnson and Boehringer Ingelheim GmbH.

We also know of several smaller early-stage companies that are developing

products for use in our segment of the market.

Some of the potential competitive compounds referred to above are being developed by large,

well-financed and established pharmaceutical and biotechnology companies or have been partnered with such companies, which may give them

development, regulatory and marketing advantages over our products.

Our potential competitors include, without limitation, large healthcare companies, such as AbbVie, Axesome Therapeutics, Inc., Biogen

Inc., Eisai Co., Ltd., Takeda Pharmaceuticals, Bristol Myers Squibb, Pfizer Inc., Merck & Co., Inc., Sanofi S.A., Eli Lilly and Company,

Bayer AG, Novartis AG, Johnson and Johnson and Boehringer Ingelheim GmbH.

We also know of several smaller early-stage companies

that are developing products for use in our segment of the market.

Some of the potential competitive compounds referred to above are being

developed by large, well-financed and established pharmaceutical and biotechnology companies or have been partnered with such companies,

which may give them development, regulatory and marketing advantages over our products.

Our commercial opportunity

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and financial condition.

Changes in funding

for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise

prevent our product candidates from being developed or commercialized in a timely manner, which could negatively impact our business.

rely on the FDA to assist with the development of our product candidates.

The ability of the FDA to review and approve new drug products

can be affected by a variety of factors outside of our control, including government budget and funding levels, ability to hire and retain

key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the agency have

fluctuated in recent years as a result.

In addition, government funding of other government agencies that fund research and development

activities is subject to the political process, which is inherently fluid and unpredictable.

at the FDA and other agencies may also slow the time necessary for our product candidates to be reviewed and/or potentially approved by

necessary government agencies, which would adversely affect our business.

For example, over the last several years, including for 35 days

beginning on December 22, 2018, the U.S.

government has shut down several times and certain regulatory agencies, such as the FDA, have

had to furlough critical FDA employees and stop critical activities.

If a prolonged government shutdown occurs, it could significantly

impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our

If the timing of FDA’s review and approval of new products is delayed, the estimated timing of our drug development program

may be delayed, which would materially increase costs of drug development and harm our operations or business.

Changes in funding for the FDA and other

government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent our product

candidates from being developed or commercialized in a timely manner, which could negatively impact our business.

We rely on the FDA to assist

with the development of our product candidates.

The ability of the FDA to review and approve new drug products can be affected by a variety

of factors outside of our control, including government budget and funding levels, the FDA’s ability to hire and retain key personnel

and accept the payment of user fees, and statutory, regulatory, and policy changes.

Average review times at the agency have fluctuated

in recent years as a result.

In addition, government funding of other government agencies that fund research and development activities

is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and

other agencies may also slow the time necessary for our product candidates to be reviewed and/or potentially approved by necessary government

agencies, which would adversely affect our business.

For example, over the last several years, including for 35 days beginning on December

22, 2018, and 43 days between October 1 and November 12, 2025, the U.S.

government has shut down several times and certain regulatory

agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

If a prolonged government shutdown

occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have

a material adverse effect on our business.

If the timing of FDA’s review and approval of new products is delayed, the estimated

timing of our drug development program may be delayed, which would materially increase costs of drug development and harm our operations

Risks Related to Our Intellectual Property

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financial condition.

Risks Related to Our Affiliates’ Control

and Relationships

Members of the Board of Directors and executive

officers of our company and Hyperscale Data, Inc.

(“HDI”), contain some of the same individuals, which may present potential

conflicts of interest.

(Todd) Ault III,

our Founder, and Vice Chairman, has significant influence over our Company, directly and indirectly through his controlling equity interest

in Ault & Company, Inc.

(“Ault & Co.”), the parent of Ault Life Sciences, Inc.

(“ALSI”) and Ault Life

Sciences Fund, LLC (“ALSF”).

Ault is also the Executive Chairman and single largest stockholder (through his control

of Ault & Co.) of HDI, a publicly traded diversified holding company that owns and operates a data center at which it mines digital

assets and offers colocation and hosting services for the emerging AI ecosystems and other industries and through wholly and majority-owned

subsidiaries and strategic investments, support a diverse range of industries, including an artificial intelligence software platform,

social gaming platform, equipment rental services, defense/aerospace, industrial, automotive, medical/biopharma and hotel operations.

The Board of Directors (“Board”) and executive officers of our company and the board of directors and executive officers of

HDI contain some of the same individuals, all of whom devote a portion of their business and professional time and efforts to the respective

businesses of our company as well as HDI.

In addition to Mr.

Ault, William B.

Horne, the Chairman of the Board, is the Chief Executive

Officer and a director of HDI, Henry Nisser, our Executive Vice President, General Counsel and a director of our company, is the President,

General Counsel and a director of HDI and Kenneth S.

Cragun, our Senior Vice President of Finance is the Chief Financial Officer of HDI.

While we believe that our

business and technologies are distinguishable from those of HDI and that we do not compete in the markets in which HDI competes, Mr.

and the other named individuals may have potential conflicts of interest with respect to, among other things, potential corporate opportunities,

business combinations, joint ventures and/or other business opportunities that may become available to them, our company or HDI.

Ault and the other named individuals have agreed to devote a portion of their business and professional time and efforts

to our company, potential conflicts of interest also include the amount of time and effort devoted by each of them to the affairs of HDI.

We may be materially adversely affected if Mr.

Ault and/or the other named individuals choose to place the interests of HDI before

those of our company.

Ault and the other named individuals has agreed that, to the extent such opportunities arise, he

will carefully consider a number of factors, including whether such opportunities were presented to him in his capacity as an officer

or director of our company, whether such opportunities are within our company’s line of business or consistent with our strategic

objectives and whether our company will be able to undertake or benefit from such opportunities.

In addition, our Board has adopted a

policy whereby any future transactions between us and any of our affiliates, officers, directors, principal stockholders or any affiliates

of the foregoing will be on terms no less favorable to our company than could reasonably be obtained in “arm’s length”

transactions with independent third parties, and any such transactions will also be approved by a majority of our disinterested independent

Ault and the other named individuals owe fiduciary duties of good faith, care and loyalty to our company under

Delaware law.

However, the failure of our management to resolve any conflicts of interest in favor of our company could materially adversely

affect our business, financial condition and results of operations.

Certain provisions of our certificate of

incorporation allow concentration of voting power, which may, among other things, delay or frustrate the removal of incumbent directors

or a takeover attempt, even if such events may be beneficial to our stockholders.

Provisions of our certificate

of incorporation may delay or frustrate the removal of incumbent directors and may prevent or delay a merger, tender offer or proxy contest

involving our company that is not approved by our Board, even if those events may be perceived to be in the best interests of our stockholders.

Further, we may designate and issue separate classes of preferred stock that may entitle their holder(s) to exercise significant control

Consequently, anyone to whom or which these shares are or were issued could have sufficient voting power to significantly influence

if not control the outcome of all corporate matters submitted to the vote of our common stockholders.

Those matters could include the

election of directors, changes in the size and composition of our Board, and mergers and other business combinations involving us.

addition, through any such person’s control of our Board and voting power, the affiliate may be able to control certain decisions,

including decisions regarding the qualification and appointment of officers, dividend policy, access to capital (including borrowing from

third-party lenders and the issuance of additional debt or equity securities), and the acquisition or disposition of assets by us.

addition, the concentration of voting power in the hands of an affiliate could have the effect of delaying or preventing a change in control

of our company, even if the change in control could benefit our stockholders and may adversely affect the future market price of our common

Risks Relating to Ownership of Our Common Stock

If we are unable to comply with the continued

listing requirements of The Nasdaq Capital Market, our common stock could be delisted, which would adversely affect our common stock

market price and liquidity and reduce our ability to raise capital.

The listing of our common

stock on the Nasdaq Capital Market is contingent on our compliance with the Nasdaq Capital Market’s conditions for continued listing.

While we are currently in compliance with Nasdaq listing requirements, we have not been in compliance in the past year.

If we were to fail to meet

a Nasdaq Capital Market listing requirement, we may be subject to delisting by the Nasdaq Capital Market.

In the event our common stock

is no longer listed for trading on the Nasdaq Capital Market, our trading volume and share price may decrease and we may experience further

difficulties in raising capital which could materially affect our operations and financial results.

Further, delisting from the Nasdaq

Capital Market could also have other negative effects, including potential loss of confidence by investors, employees, and fewer business

development opportunities.

Finally, delisting could make it harder for us to raise capital and sell securities.

We are not in compliance

with the Nasdaq continued listing requirements.

If we are unable to regain compliance with, or thereafter maintain compliance with, the

continued listing requirements of The Nasdaq Capital Market, our Common Stock could be delisted, which would adversely affect our Common

Stock’s market price and liquidity and reduce our ability to raise capital.

2026, we were notified by the staff of The Nasdaq Stock Market LLC (“Nasdaq”) that that our stockholders’

equity as reported in its Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2026 (the “Form 10-Q”), did

not satisfy the continued listing requirement under Nasdaq Listing Rule 5550(b)(1) for the Nasdaq Capital Market, which requires that

a listed company’s stockholders’ equity be at least $2.5 million.

As reported on its Form 10-Q, our stockholders’ equity

as of January 31, 2026 was approximately $2.2 million.

As reported in this Annual Report, our stockholders’ equity as of April 30,

2026 was approximately $0.7 million.

In accordance

with Nasdaq Listing Rules, we were provided an initial period of 45 calendar days, or until May 4, 2026, to submit a plan to regain compliance.

On May 4, 2026, we submitted a plan to regain compliance with Nasdaq Listing Rule 5550(b)(1) to Nasdaq.

On May 19, 2026, Nasdaq granted

us an extension of time to regain compliance on or before September 16, 2026.

be no assurance that we will be able to regain compliance with the minimum stockholders’ equity requirement on or before September

16, 2026, or if we do, that we will in the future be able to maintain compliance with the stockholders’ equity requirement or any

other Nasdaq listing standard.

If our common

stock is delisted, it could be more difficult to buy or sell our common stock and to obtain accurate quotations, and the price of our

common stock could suffer a material decline.

Delisting could also impair the liquidity of our common stock and could harm our ability

to raise capital through alternative financing sources on terms acceptable to us, or at all, and may result in potential loss of confidence

by investors, employees, and fewer business development opportunities.

We do not know whether an active market

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and divert management’s attention and resources from our business.

If there are substantial sales of shares

of our common stock, the price of our common stock could decline.

The price of our

common stock could decline if there are substantial sales of our common stock, particularly sales by our directors, executive officers

and significant stockholders, or if there is a large number of shares of our common stock available for sale and the market perceives

that sales will occur.

If there are substantial sales of shares of our common stock,

the price of our common stock could decline.

The price of our common stock

could decline if there are substantial sales of our common stock, particularly sales by our directors, executive officers and significant

stockholders, or if there is a large number of shares of our common stock available for sale and the market perceives that sales will

As of July 22, 2026, we had 4,791,525 shares of our common stock outstanding.

Shares held by directors, executive

officers and other affiliates will be subject to volume limitations under Rule 144 under the Securities Act and various vesting agreements.

We have registered shares of common stock that we have issued and may issue under our employee equity incentive plans, which shares may

be sold freely in the public market upon issuance.

Sales of our common stock by current stockholders may make it more difficult for us

to sell equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate, and make it more

difficult for other stockholders to sell shares of our common stock.

market price of the shares of our common stock could decline as a result of the sale of a substantial number of our shares of common stock

in the public market or the perception in the market that the holders of a large number of shares intend to sell their shares.

unable to predict the effect that sales may have on the prevailing market price of our common stock.

The concentration

of our stock ownership will limit your ability to influence corporate matters, including the ability to influence the outcome of director

elections and other matters requiring stockholder approval.

executive officers, directors and the holders of more than 5% of our outstanding common stock, in the aggregate, beneficially own a significant

percentage of our common stock.

As a result, these stockholders, acting together, will have significant influence over all matters that

require approval by our stockholders, including the election of directors and approval of significant corporate transactions.

actions might be taken even if other stockholders oppose them.

This concentration of ownership might also have the effect of delaying

or preventing a change of control of our company that other stockholders may view as beneficial.

Shares held by directors, executive officers and

other affiliates will be subject to volume limitations under Rule 144 under the Securities Act and various vesting agreements.

registered shares of common stock that we have issued and may issue under our employee equity incentive plans, which shares may be sold

freely in the public market upon issuance.

Sales of our common stock by current stockholders may make it more difficult for us to sell

equity or equity-related securities in the future at a time and price that we deem reasonable or appropriate, and make it more difficult

for other stockholders to sell shares of our common stock.

The market price of the shares

of our common stock could decline as a result of the sale of a substantial number of our shares of common stock in the public market or

the perception in the market that the holders of a large number of shares intend to sell their shares.

We are unable to predict the effect

that sales may have on the prevailing market price of our common stock.

Our bylaws provide that the Court of Chancery

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adverse effect on our business, financial condition, and results of operations.

Certain provisions of our certificate of

incorporation allow concentration of voting power, which may, among other things, delay or frustrate the removal of incumbent directors

or a takeover attempt, even if such events may be beneficial to our stockholders.

Provisions of our certificate

of incorporation may delay or frustrate the removal of incumbent directors and may prevent or delay a merger, tender offer or proxy contest

involving our Company that is not approved by our Board, even if those events may be perceived to be in the best interests of our stockholders.

Further, we may designate and issue separate classes of preferred stock that may entitle their holder(s) to exercise significant control

Consequently, anyone to whom or which these shares are or were issued could have sufficient voting power to significantly influence

if not control the outcome of all corporate matters submitted to the vote of our common stockholders.

Those matters could include the

election of directors, changes in the size and composition of our Board, and mergers and other business combinations involving us.

addition, through any such person’s control of our Board and voting power, the affiliate may be able to control certain decisions,

including decisions regarding the qualification and appointment of officers, dividend policy, access to capital (including borrowing from

third-party lenders and the issuance of additional debt or equity securities), and the acquisition or disposition of assets by us.

addition, the concentration of voting power in the hands of an affiliate could have the effect of delaying or preventing a change in control

of our Company, even if the change in control could benefit our stockholders and may adversely affect the future market price of our common

General Risk Factors

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If we do not successfully develop and commercialize product candidates based upon our technological approach,

we will not be able to obtain product revenue in future periods, which would make it unlikely that we would ever achieve profitability.

we will not be able to obtain product revenue in future periods, which would make it impossible for us to ever achieve profitability.

We may experience product recalls or inventory

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to sell your shares of common stock at or above the initial public offering price or at the time you would like to sell.

We have identified a material weakness in

our internal control over financial reporting.

If our remediation of this material weakness is not effective, or if we experience additional

material weaknesses in the future or otherwise fail to maintain an effective system of internal controls in the future, we may not be

able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in

us and, as a result, the value of our common stock.

We have limited accounting

personnel to adequately execute our accounting processes and other supervisory resources with which to address our internal control over

We have identified material weaknesses in

our internal control over financial reporting and may identify additional material weaknesses in the future or otherwise fail to maintain

an effective system of internal controls, which may result in material misstatements of our financial statements or cause us to fail to

meet our periodic reporting obligations.

We are required to comply

with certain provisions of Section 404 of the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley Act”).

Section 404 requires that

we document and test our internal control over financial reporting and issue management’s assessment of our internal control over

financial reporting.

In connection with the audit of our financial statements for the year ended April 30, 2025, we identified

material weaknesses in our internal control over financial reporting.

A material weakness is a deficiency, or combination of deficiencies,

in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our financial

statements will not be prevented or detected on a timely basis.

The material weaknesses related to a lack of sufficient number of qualified

personnel within our accounting function to adequately segregate duties, to perform sufficient reviews and approval of manual journal

entries posted to the general ledger and to consistently execute review procedures over general ledger account reconciliations, financial

statement preparation and accounting for non-routine transactions and, we have not designed and implemented effective Information Technology

General Controls (“ITGC”) related to access controls to payment and financial accounting systems.

Due to the size of our company

and our limited financial resources, we will need to increase our accounting department in the future to fully remediate our current weakness.

The material weakness will not be considered to be remediated until the applicable remediated controls are operating for a sufficient

period of time and management has concluded, through testing, that these controls are operating effectively.

If the steps we take do not correct the material

weakness in a timely manner, we will be unable to conclude that we maintain effective internal control over financial reporting.

there could continue to be a reasonable possibility that a material misstatement of our financial statements would not be prevented or

detected on a timely basis.

As a public company, we are

required to maintain internal control over financial reporting and to report any material weaknesses in such internal controls.

perform system and process evaluation and testing of our internal controls over financial reporting to allow management to report on the

effectiveness of our internal controls over financial reporting, as required by Section 404 of the Sarbanes-Oxley Act.

The Sarbanes-Oxley

Act also requires that our management report on internal control over financial reporting be attested to by our independent registered

public accounting firm, to the extent we are no longer an “emerging growth company,” as defined in the Jumpstart Our Business

Startups Act of 2012 (JOBS Act).

We do not expect our independent registered public accounting firm to attest to our management report

on internal control over financial reporting for so long as we are an emerging growth company.

We are in the process of enhancing

our internal control over financial reporting required to comply with this obligation, which process will be time-consuming, costly

and complicated.

If we identify any additional material weaknesses in our internal control over financial reporting, if we are unable

to comply with the requirements of Section 404 in a timely manner, if we are unable to assert that our internal control over financial

reporting is effective, or when required in the future, if our independent registered public accounting firm is unable to express an opinion

as to the effectiveness of our internal control over financial reporting, investors may lose confidence in the accuracy and completeness

of our financial reports and the market price of our common stock could be adversely affected, and we could become subject to investigations

by the Nasdaq Stock Market, the SEC, or other regulatory authorities, which could require additional financial and management resources.

Management assessed the effectiveness of our internal control over financial reporting as of April 30, 2026.

this assessment, we used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal

Control — Integrated Framework.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over

financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements

will not be prevented or detected on a timely basis.

Based on our assessment, as of April 30, 2026, we concluded that our internal control

over financial reporting contained a material weakness.

The weakness will not be considered

remediated, however, until the applicable controls operate for a sufficient period of time and our management has concluded, through testing,

that these controls are operating effectively.

If we fail to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, the

accuracy and timeliness of the filing of our annual and quarterly reports may be materially adversely affected and could cause investors

to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock.

In addition, a material weakness in the effectiveness of our internal control over financial reporting could result in an increased chance

of fraud and the loss of customers, reduce our ability to obtain financing and require additional expenditures to comply with these requirements,

each of which could have a material adverse effect on our business, results of operations and financial condition.

We may have trouble hiring additional qualified

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An “interested stockholder” is a person who, together with affiliates

and associates, owns, or within three years did own, 15% or more of the corporation’s outstanding voting stock.

These provisions

may have the effect of delaying, deferring or preventing a change in control of our company.

and associates, owns, or within the past three years did own, 15% or more of the corporation’s outstanding voting stock.

provisions may have the effect of delaying, deferring or preventing a change in control of our Company.

Failure to build our finance infrastructure

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to cover our stock, we could lose visibility in the market for our common stock, which in turn could cause our stock price to decline.

We are an “emerging growth company,”

and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.

We are an “emerging

growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

For so long as we remain an emerging

growth company, we are permitted and plan to rely on exemptions from certain disclosure requirements that are applicable to other public

companies that are not emerging growth companies.

These exemptions include not being required to comply with the auditor attestation requirements

of SOX Section 404, not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight

Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the

audit and the financial statements, reduced disclosure obligations regarding executive compensation, and exemptions from the requirements

of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously

As a result, the information we provide stockholders will be different than the information that is available with respect to

other public companies.

In this Annual Report, we have not included all of the executive compensation-related information that would be

required if we were not an emerging growth company.

We cannot predict whether investors will find our common stock less attractive if

we rely on these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active trading market

for our common stock, and our stock price may be more volatile.

We will incur increased costs as a result

of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate

governance practices.

As a public company, and particularly

after we are no longer an emerging growth company (or, to a lesser extent, a smaller reporting company), we will incur significant legal,

accounting, and other expenses that we did not incur as a private company.

Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform

and Consumer Protection Act, the listing requirements of The Nasdaq Capital Market, and other applicable securities rules and regulations

impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls

and corporate governance practices.

We expect that we will need to hire additional accounting, finance, and other personnel in connection

with our becoming, and our efforts to comply with the requirements of being, a public company, and our management and other personnel

will need to devote a substantial amount of time towards maintaining compliance with these requirements.

These requirements will increase

our legal and financial compliance costs and will make some activities more time-consuming and costly.

For example, we expect that the

rules and regulations applicable to us as a public company may make it more difficult and more expensive for us to obtain director and

officer liability insurance, which could make it more difficult for us to attract and retain qualified members of our Board.

We are currently

evaluating these rules and regulations and cannot predict or estimate the amount of additional costs we may incur or the timing of such

These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and,

as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies.

result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance

Our charter provides for limitations of

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the extent we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions.

We could be subject

to securities class action litigation.

the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities.

This risk is especially relevant for us because biopharmaceutical companies have experienced significant stock price volatility in recent

If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources,

which could harm our business.

We could be subject to securities class

action litigation.

In the past, securities class

action litigation has often been brought against a company following a decline in the market price of its securities.

This risk is especially

relevant for us because biopharmaceutical companies have experienced significant stock price volatility in recent years.

If we face such

litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors