Nomad Power Solutions (NMAD) risk factors, FY2024 10-K

Risks Related to Our Financial Resources and Capital Needs

1. 01We are engaged in early-stage research and as such might not be successful in our efforts to develop a portfolio of commercially viable products
2. 02We have incurred substantial losses since our inception and anticipate that we will continue to incur substantial and increasing losses for the foreseeable future
3. 03Our independent registered public accounting firm has expressed substantial doubt about our ability to continue as a going concern
4. 04We currently have no source of revenues. We might never generate revenues or achieve profitability
5. 05Our ability to use net operating losses to offset future taxable income might be subject to limitations
6. 06The state net operating loss carryovers include approximately $19,141,000 that were incurred in the State of New York and approximately $16,695,000 that were incurred in the State of California, which are subject to various restrictions and limitations

Risks Related to the Development and Regulatory Approval of Our Product Candidates

1. 07Clinical-stage biopharmaceutical companies with product candidates in clinical development face a wide range of challenging activities which might entail substantial risk
2. 08We might find it difficult to enroll patients in our clinical trials which could delay or prevent the start of clinical trials for our product candidate
3. 09Clinical drug development involves a lengthy and expensive process with an uncertain outcome
4. 10Risks associated with operating in foreign countries could materially adversely affect our product development
5. 11Any of these events could prevent us from achieving or maintaining market acceptance of our lead product candidate, if approved
6. 12There is a risk that one or more of our clinical trials could be placed on hold by regulatory authorities due to serious adverse events (SAEs) related to our drug candidate or to another company’s drug used in combination in one of our clinical trials
7. 13Our future success is dependent on the regulatory approval of our lead product candidate
8. 14Our lead product candidate and future product candidates could fail to receive regulatory approval from the FDA
9. 15Failure to obtain regulatory approval in international jurisdictions would prevent our lead product candidate from being marketed abroad
10. 16Even if our current primary product candidate received regulatory approval, it might still face future development and regulatory difficulties
11. 17The occurrence of any event or penalty described above might inhibit our ability to successfully commercialize our intended product and generate revenues

Risks Related to Our Dependence on Third Parties

1. 18We depend on certain key scientific personnel for our success who do not work full time for us. The loss of any such personnel could adversely affect our business, financial condition and results of operations
2. 19We expect to rely heavily on third parties for the conduct of clinical trials of our product candidates. If these clinical trials are not successful, or if we or our collaborators are not able to obtain the necessary regulatory approvals, we will not be able to commercialize our product candidates
3. 20The development process necessary to obtain regulatory approval is lengthy, complex and costly. If we or our collaborative partners do not obtain necessary regulatory approvals, then our business would not be successful, and the market price of our common stock could decline substantially
4. 21Business interruptions could adversely affect future operations, revenues, and financial conditions, and might increase our costs and expenses
5. 22Our failure to find third party collaborators to assist or share in the costs of product development could materially harm our business, financial condition or results of operations
6. 23We might be subject to claims by third parties asserting that our employees, consultants, collaborators contractors or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property

Risks Related to Our Intellectual Property

1. 24Our patents and patent applications are owned solely by our wholly-owned subsidiary, Lixte Biotechnology, Inc., except in several instances where they are jointly owned with one of our collaborators
2. 25If we do not obtain patent term extension in the United States under the Hatch-Waxman Act or in foreign countries under similar legislation, our business might be materially harmed
3. 26If we fail to comply with our obligations in agreements under which we have licensed or, might license, intellectual property rights from third parties, or if we otherwise experience disruptions to our business relationships with our licensors, we could lose rights that are important to our business
4. 27If disputes over intellectual property that we have licensed, or might in the future license, prevent or impair our ability to maintain our licensing arrangements on acceptable terms, we may be unable to successfully develop or commercialize the affected product candidates
5. 28We might infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing or increase the costs of commercializing our product candidates
6. 29We might be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of one or more third parties
7. 30Our intellectual property might not be sufficient to protect our intended products from competition, which might negatively affect our business as well as limit our partnership or acquisition appeal
8. 31If we are not able to protect and control our unpatented trade secrets, know-how and other technological innovation, we might suffer competitive harm
9. 32If we are unable to protect our intellectual property rights, our competitors might develop and market products with similar or identical features that might reduce demand for our potential products
10. 33We will be able to protect our intellectual property rights in patents and trade secrets from unauthorized use by third parties only to the extent that such intellectual property rights are covered by valid and enforceable patents or are effectively maintained as trade secrets and we enforce these rights

Risks Related to Commercialization of Our Current Product Candidate and Future Product Candidates

1. 34Our commercial success depends upon attaining significant market acceptance of our current product candidate and future product candidates, if approved, among physicians, patients, healthcare payors and cancer treatment centers
2. 35Even if we are able to commercialize our lead product candidate or any future product candidates, the products might not receive coverage or adequate reimbursement from third party payors in the United States and in other countries in which we seek to commercialize our intended products, which could harm our business
3. 36Healthcare legislative measures aimed at reducing healthcare costs might have a material adverse effect on our business and results of operations
4. 37Price controls might be imposed in foreign markets, which might adversely affect our future profitability

Risks Related to Healthcare Compliance Regulations

1. 38Our employees might engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation
2. 39Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we might develop

Risks Related to our Business Operations

1. 40We face substantial competition, which might result in others discovering, developing or commercializing products before or more successfully than we do
2. 41Our business might be adversely affected by the coronavirus or other pandemics
3. 42Significant disruptions of information technology systems, computer system failures or breaches of information and cyber security could adversely affect our business
4. 43We might need to grow the size of our organization in the future, and we might experience difficulties in managing this growth
5. 44Unstable market and economic conditions and adverse developments with respect to financial institutions and associated liquidity risk may have serious adverse consequences on our business, financial condition and stock price

Risks Related to Owning our Securities

1. 45We are a “smaller reporting company” and we have elected to comply with certain reduced reporting and disclosure requirements which could make its common stock less attractive to investors
2. 46We cannot predict if investors will find our common stock less attractive because we might rely on these exemptions. If some investors find our common stock less attractive as a result, there might be a less active trading market for our common stock and our stock price might be more volatile
3. 47The publicly-traded warrants that we issued in our November 2020 public offering are speculative in nature
4. 48Holders of the warrants have no rights as a common stockholder until they acquire our common stock
5. 49There is a limited market for the warrants to purchase shares of our common stock
6. 50Provisions of certain warrants could discourage a change-in control transaction involving a third party
7. 51July 20, 2023 sale of common stock and warrants
8. 52February 13, 2025 sale of common stock and warrants
9. 53Our management has broad discretion over the use of the proceeds from any stock offerings we may conduct in the future and we may apply it to uses that do not improve our operating results or the value of our common stock
10. 54The price of our common stock or warrants might fluctuate substantially

Risks Related to the Company’s Common Stock

1. 55The Company’s common stock and the warrants are traded on The Nasdaq Capital Market under the symbols “LIXT” and “LIXTW”, respectively
2. 56On October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement, which outlined the Company’s proposed initiatives to regain compliance by raising equity capital through various registered equity offerings
3. 57A sale or perceived sale of a substantial number of shares of our common stock might cause the price of our common stock to decline
4. 58Market and economic conditions might negatively impact our business, financial condition and share price
5. 59If securities or industry analysts do not publish research or reports, or publish unfavorable research or reports about our business, our stock price and trading volume might decline
6. 60Future sales and issuances of our common stock could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall
7. 61We do not intend to pay cash dividends on our shares of common stock so any returns will be limited to the value of our shares
8. 62We might be at risk of securities class action litigation
9. 63Our Certificate of Incorporation and our Amended and Restated Bylaws, and Delaware law might have anti-takeover effects that could discourage, delay or prevent a change in control, which might cause our stock price to decline
10. 64Financial reporting obligations of being a public company in the United States are expensive and time-consuming, and our management will be required to devote substantial time to compliance matters
11. 65If we fail to comply with the rules under Sarbanes-Oxley related to accounting controls and procedures in the future, or, if we discover material weaknesses and other deficiencies in our internal control and accounting procedures, our stock price could decline significantly and raising capital could be more difficult