Rezolute (RZLT) risk factors, 2026 10-K

Risks Related to Our Product Development and Commercialization

1. 01The supplemental information provided to the FDA to support our belief in the effectiveness of ersodetug in the treatment of congenital HI might not result in a viable path forwardnew
2. 02There is no guarantee that the FDA will not consider the results of the sunRIZE trial when it considers additional regulatory steps related to ersodetug and its treatment of other conditionsnew
3. 03If our clinical trials fail to replicate positive results from earlier preclinical studies or clinical trials conducted by us or third parties, we may be unable to successfully develop, obtain regulatory approval for or commercialize our product candidatesnew
4. 04Interim, “topline” and preliminary data from clinical trials may change as more data become available, are not necessarily predictive of the final results of the completed study or the results of other ongoing or future studies and are subject to audit and verification procedures that could result in material changesnew
5. 05Modifications to the upLIFT trial may fail to produce effective resultsnew
6. 06Any 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
7. 07Adverse events in our clinical trials may force us to stop development of our product candidates or prevent regulatory approval of our product candidates
8. 08After 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
9. 09If our product candidates do not meet safety or efficacy requirements, they will not receive regulatory approval and we will be unable to market them
10. 10Any delay in, or failure to receive or maintain, approval for any of our product candidates could prevent us from ever generating meaningful revenues or achieving profitability
11. 11Due 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
12. 12Any 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
13. 13We may be unable to manage our anticipated growth effectively
14. 14Further, our anticipated growth will place additional strain on our suppliers, resulting in an increased need for us to carefully monitor quality assurance. Any failure by us to manage our growth effectively could have an adverse effect on our ability to achieve our development and commercialization goals
15. 15If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages

Risks Related to Our Business

1. 16Failure of our clinical trials could expose us to litigation and other legal claims, which could materially and adversely affect our business, financial condition and results of operationsnew
2. 17We face potential product liability exposure, and, if successful claims are brought against us, we may incur substantial liability
3. 18We may not be able to use a significant portion of our net operating loss carryforwards, which could adversely affect our profitability68% rewritten
4. 19If 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. 20In the future, we may no longer qualify as a smaller reporting company or non-accelerated filer, which could increase our compliance costs and reporting obligationsnew
6. 21Our collection, use, processing, and cross-border transfer of personal information, including individually identifiable health information, is governed by restrictive regulations
7. 22We could recognize losses on securities held in our marketable debt securities portfolio, particularly if interest rates increase or economic and market conditions deteriorate
8. 23Unfavorable global and regional economic and political conditions could adversely affect our business, financial condition or results of operations
9. 24Certain Provisions of Nevada law may have anti-takeover effects

Risks Related to Our Intellectual Property

1. 25Our 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. 26If 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. 27We may be unable to adequately prevent disclosure of trade secrets and other proprietary information
4. 28Litigation 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. 29If 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 market67% rewritten
6. 30sufficient to protect our technology. The laws of foreign jurisdictions in which we intend to sell our products may not protect our rights to the same extent as the laws of the United Statesnew

Risks Related to Our Common Stock

1. 31Offers or availability for sale of a substantial number of shares of our common stock may cause the price of our common stock to decline
2. 32Investor relations activities and supply and demand factors may affect the price of our common stock