Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 27

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 27
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 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 that the product be approved for reimbursement before the product can be approved for sale
in that country. We may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval
by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority
outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. We may
not be able to file for marketing approvals and may not receive the necessary approvals to commercialize our product candidates in any
particular market.

Additional time and costs may be required to obtain marketing authorizations for the ARB-based product candidate that we develop as part of a combination therapy.

One of our product candidates currently in early-stage
development is a novel adjunct therapy intended to be administered alongside existing cancer treatments to improve therapeutic outcomes.
It is a nanoparticles-based formulation of angiotensin receptor blockers (ARB) for intravenous administration. Developing a drug as part
of a combination regimen introduces unique complexities compared to monotherapy. In clinical development, combinations must demonstrate
not only the safety and efficacy of the investigational product itself, but also its added value beyond existing standards of care. This
requires larger and more complex trial designs, often involving multiple treatment protocols and study arms to isolate the contribution
of each agent. The required studies may fail to show statistically significant or clinically meaningful improvements, or the benefits
may be offset by increased toxicity, cost, or complexity of treatment. If we are unable to generate robust evidence that our therapy
enhances the efficacy of existing treatments, regulators may not approve it, physicians may be reluctant to prescribe it, and payors
may decline to reimburse for its use.

These operative material risks can be summarized as follows:

| ● | Clinical                                                                                        
 Risk. Combination therapy carries the risk of unexpected toxicity due to drug–drug              
 interactions or overlapping adverse effects. Even if each component drug is independently       
 well characterized, the safety profile of the combination may differ significantly, and adverse 
 events could delay or prevent clinical development.