Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 21

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 21
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 trials, the results of such trials may not gain FDA approval. Even if approved, our products may not be commercially successful.

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If We Cannot Successfully Develop our Products and Technology, Our Business Model Would Need to be Changed or We Would Be Required to Change Our Priorities and Opportunities.

There are many products and programs that seem promising to us which we could pursue. However, with limited resources, we may decide to change priorities and shift programs

The choices we make will be dependent upon numerous contemporaneous factors, some of which we cannot predict. We cannot be sure that our business model, as it currently exists or as it may evolve, will enable us to become profitable or to sustain operations. We have not demonstrated our ability to successfully complete large-scale, pivotal clinical trials, obtain regulatory approvals, manufacture a commercial scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization or manage an operational public company. Because of our limited operating history outside of being a research company, we have limited insight into trends that may emerge and affect our business, and errors may be made in developing an approach to address those trends and the other challenges faced by per-clinical biopharmaceuticalcompanies such as our Company. Failure to adequately respond to such trends and challenges could cause our business, results of operations and financial condition to suffer or fail. Further, our limited operating history may make it difficult for our stockholders to make any predictions about our likelihood of future success or viability. Even if we were to achieve successful clinical results in our programs, successful approval, marketing, and sales of our novel therapeutics are also critical to the financial future of our company. Our human-use products are not yet approved for sale in the United States and other jurisdictions, and we may never obtain these approvals regardless of whether we achieve successful clinical trial results utilizing such therapies. Even if we do obtain approvals to sell our novel therapies in the United States, these sales may not be as large or as timely as we expect.

We face risks related to compliance with corporate governance laws and financial reporting standards.

We also expect that there will continue to be new laws, regulations and industry standards concerning privacy, data protection and information security proposed and enacted in various jurisdictions. Any failure or perceived failure by us to comply with our posted privacy policies, our privacy-related obligations to users or other third parties or any other legal obligations or regulatory requirements relating to privacy, data protection or information security may result in governmental