Rezolute (RZLT) risk factors, FY2024 10-K

Risks Related to Our Product Development and Commercialization

1. 01Any delays in the commencement or completion, or termination or suspension, of our future clinical trials, if any, could result in increased costs to us, delay or limit our ability to generate revenue and adversely affect our commercial prospects
2. 02Adverse events in our clinical trials may force us to stop development of our product candidates or prevent regulatory approval of our product candidates
3. 03We are exposed to additional risks as we conduct the sunRIZE study outside of the U.S. and may not be successful in meeting the study’s primary endpoint
4. 04After the completion of our clinical studies, we cannot predict whether or when we will obtain regulatory approval to commercialize our product candidates and we cannot, therefore, predict the timing of any future revenue from these product candidates
5. 05If our product candidates do not meet safety or efficacy requirements, they will not receive regulatory approval and we will be unable to market them
6. 06Any delay in, or failure to receive or maintain, approval for any of our products could prevent us from ever generating meaningful revenues or achieving profitability
7. 07Due to our reliance on contract research organizations or other third parties to conduct clinical trials, we may not have complete control over the timing, conduct and expense of our clinical trials
8. 08Any failure or delay by our third-party suppliers on which we rely or intend to rely to provide materials necessary to develop and manufacture our drug products may delay or impair our ability to commercialize our product candidates
9. 09candidates, the commercial launch of our product candidates would be delayed or there would be a shortage in supply of such product candidates, which would impair our ability to generate revenues from the sale of our product candidates
10. 10If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages
11. 11Guidelines and recommendations published by various organizations may adversely affect the use of any products for which we may receive regulatory approval

Risks Related to Our Business

1. 12Changes in financial accounting standards or policies have affected, and in the future may affect, our reported financial condition or results of operations; there are inherent limitations to our system of internal controls; changes in corporate governance policies and practices may impact our business
2. 13We face potential product liability exposure, and, if successful claims are brought against us, we may incur substantial liability
3. 14We may not be able to use a significant portion of our net operating loss carryforwards, which could adversely affect our profitability
4. 15If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate and timely financial statements could be impaired, investors may lose confidence in our financial reporting and the trading price of our common stock may decline
5. 16Operations outside the United States may be affected by different local politics, business and cultural factors, different regulatory requirements and prohibitions between jurisdictions
6. 17Our collection, use, processing, and cross-border transfer of personal information, including individually identifiable health information, is governed by restrictive regulations
7. 18We could recognize losses on securities held in our marketable debt securities portfolio, particularly if interest rates increase or economic and market conditions deteriorate
8. 19Unfavorable global and regional economic, political and health conditions could adversely affect our business, financial condition or results of operations
9. 20Certain Provisions of Nevada law may have anti-takeover effects

Risks Related to Our Intellectual Property

1. 21Our current patent positions and license portfolio may not include all patent rights needed for the full development and commercialization of our product candidates. We cannot be sure that patent rights we may need in the future will be available to license on commercially reasonable terms, or at all
2. 22If our or our licensors’ patent positions do not adequately protect our product candidates or any future products, others could compete with us more directly, which would harm our business
3. 23We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
4. 24Litigation regarding patents, patent applications and other proprietary rights may be expensive and time consuming. If we are involved in such litigation, it could cause delays in bringing product candidates to market and harm our ability to operate
5. 25If our patent and other intellectual property protection is inadequate, future sales and profits may never materialize or competitors could force our products completely out of the market

Risks Related to Our Common Stock

1. 26Exercise or conversion of warrants, stock options and other convertible securities will dilute shareholder’s percentage of ownership
2. 27Our stock price may be volatile
3. 28Offers or availability for sale of a substantial number of shares of our common stock may cause the price of our common stock to decline
4. 29Investor relations activities and supply and demand factors may affect the price of our common stock
5. 30We have no current plan to pay dividends on our common stock and investors may lose the entire amount of their investment
6. 31Changes in U.S. tax law could adversely affect our business