Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 26

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 26
---
 and security breaches from inadvertent or intentional actions by our employees, partners or vendors. These systems are
also vulnerable to attacks by malicious third parties and may be susceptible to intentional or accidental physical damage to the infrastructure
maintained by us or by third parties. While we have taken steps to protect such information and have invested in all applicable regulatory
requirements compliance systems to do so, there can be no guarantee that our efforts will prevent service interruptions or security breaches
in our systems or the unauthorized or inadvertent wrongful use or disclosure of confidential information that could adversely affect
our business operations or result in the loss, dissemination or misuse of critical or sensitive information. The increasing sophistication
and frequency of cybersecurity threats, including targeted data breaches, ransomware attacks designed to encrypt our data for ransom
and other malicious cyber activities, pose a significant risk to the integrity and confidentiality of our data systems. A breach our
security measures or the accidental loss, inadvertent disclosure, unapproved dissemination, misappropriation or misuse of trade secrets,
proprietary information or other confidential information, whether as a result of theft, hacking, fraud, trickery or other forms of deception,
or for any other cause, could enable others to produce competing products, use our proprietary technology or information, and/or adversely
affect our business position. Further, any such interruption, security breach, loss or disclosure of confidential information could result
in financial, legal, business and reputational harm to us and could have a material adverse effect on our business, financial position,
results of operations and/or cash flow.

<div align='center'>12</div>

Risks Relating to the Development and Commercialization of our Drug Candidates and Regulatory Approval

The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and even if we obtain approval for a product candidate in one country or jurisdiction, we may never obtain approval for or commercialize it in any other jurisdiction, which would limit our ability to realize our full market potential.

In order to market and sell our products in
the United States, the European Union and other jurisdictions, we or our third-party collaborators must obtain separate marketing
approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve
additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. Regulatory
approval processes outside the United States generally include all of the risks associated with obtaining FDA approval. In addition,
in many countries outside the United States, it is required