Alzamend Neuro (ALZN) risk factors, FY2026 10-K

Risks Related to Our Company, Early Stage of Clinical Development and Financial Condition

1. 01We 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
2. 02Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern39% rewritten
3. 03We are at an early stage of clinical development and currently have no source of near-term revenue and may never become profitable

Risks Related to Our Product Candidates

1. 04We have both operational and financial milestones that must be met to maintain the licensing rights to our current technology and intellectual property from the Licensor26% rewritten
2. 05$ 10,000,000 Upon FDA NDA approval
3. 06$ 10,000,000 Upon first commercial sale
4. 07$ 16,000,000 First commercial sale
5. 08If 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
6. 09We are substantially dependent on the success of our product candidates, which may not receive regulatory approval or be successfully commercialized
7. 10AL001 and ALZN002 may not achieve market acceptance, which would significantly limit our ability to generate revenue
8. 11Problems in the manufacturing process, failure to comply with manufacturing regulations or unexpected increases in manufacturing costs could harm our business, results of operations and financial condition
9. 12Serious 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
10. 13The course of medical treatment for human patients is, and will continue to be, expensive. We expect that most patients and their families will not be capable of paying for our potential products themselves

Risks Related to Development and Regulatory Approval of Our Drug Candidates

1. 14The 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
2. 15There is a high rate of failure for drug candidates proceeding through clinical trials
3. 16Most attempts at drug approval for Alzheimer’s have failed32% rewritten
4. 17Clinical trials for AL001 or ALZN002 can be expensive, time consuming, uncertain and susceptible to change, delay or termination
5. 18The occurrence of any of the foregoing could have a material adverse effect on our business, results of operations and financial condition. See the risk factor “There is a high rate of failure for drug candidates proceeding through clinical trials” above
6. 19In summary, we cannot guarantee that our product candidates will receive breakthrough therapy designations and, even if one does, we cannot guarantee that such designations will have any bearing on the FDA’s review or approval of our product candidates
7. 20AL001 or ALZN002 and any of our future product candidates, if approved, may cause or contribute to adverse medical events that we are required to report to the FDA and regulatory authorities in other countries and, if we fail to do so, we could be subject to sanctions that would materially harm our business
8. 21Legislative or regulatory reforms with respect to products may make it more difficult and costly for us to obtain regulatory clearance or approval of AL001, ALZN002 or any of our future product candidates and to produce, market, and distribute our products after clearance or approval is obtained
9. 22The anticipated development of a REMS for AL001 or ALZN002 could cause delays in the approval process and would add additional layers of regulatory requirements that could impact our ability to commercialize AL001 and ALZN002 in the United States and reduce their market potential
10. 23If we are found in violation of “fraud and abuse” laws, we may be subject to criminal and civil penalties and/or be suspended or excluded from participation in government-run healthcare programs, which may adversely affect our business, financial condition and results of operations

Risks Related to Our Business and Industry

1. 24If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop AL001, ALZN002 or any future product candidates, conduct our in-licensing and development efforts or commercialize AL001, ALZN002 or any of our future product candidates
2. 25We expect to face substantial competition, with other entities possibly discovering, developing or commercializing products before, or more successfully than we do
3. 26Changes 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

Risks Related to Our Intellectual Property

1. 27We may be forced to litigate to enforce or defend our intellectual property rights, or the intellectual property rights of our licensors
2. 28We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
3. 29We may become subject to third parties’ claims alleging infringement of patents and proprietary rights or seeking to invalidate our patents or proprietary rights, which would be costly, time-consuming and, if successfully asserted against us, delay or prevent the development and commercialization of AL001 or ALZN002
4. 30We expect to rely upon a combination of patents, trade secret protection as well as confidentiality and license agreements to protect the intellectual property related to our product and our current product candidates and our development programs
5. 31Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect AL001 and ALZN002
6. 32Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with any of these requirements
7. 33We may not be able to protect our intellectual property rights throughout the world

Risks Relating to Legal Matters

1. 34If product liability lawsuits are brought against us, we will incur substantial liabilities and may be required to limit the commercialization of AL001 or ALZN002

Risks Relating to Ownership of Our Common Stock

1. 35There can 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 standardNew
2. 36We do not know whether an active market will be sustained; as a result, it may be difficult for you to sell your shares of our common stock
3. 37The market price of our common stock is volatile, which could result in substantial losses for investors
4. 38If there are substantial sales of shares of our common stock, the price of our common stock could decline63% rewritten
5. 39Certain 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
6. 40We must effectively manage the growth of our operations, or our Company will suffer
7. 41We may not be successful in our efforts to expand our pipeline of product candidates
8. 42We may experience product recalls or inventory losses caused by unforeseen events, cold chain interruption and testing difficulties
9. 43Because we do not intend to pay dividends on our common stock, you must rely on stock appreciation for any return on your investment85% rewritten
10. 44We may have trouble hiring additional qualified personnel
11. 45Failure of our information technology systems could significantly disrupt the operation of our business
12. 46We are subject to various claims and legal actions arising in the ordinary course of our business
13. 47Certain provisions of our certificate of incorporation, bylaws and Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to complete, even if such a transaction were in the stockholders’ interest
14. 48Failure to build our finance infrastructure and improve our accounting systems and controls could impair our ability to comply with the financial reporting and internal controls requirements for publicly traded companies
15. 49If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our stock, the price of our common stock could decline
16. 50Our charter provides for limitations of director liability and indemnification of directors and officers and employees
17. 51These limitations of liability do not apply to liabilities arising under the federal or state securities laws and do not affect the availability of equitable remedies such as injunctive relief or rescission
18. 52We could be subject to securities class action litigation