Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 27

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 27
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 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.                                             |

| ● | Regulatory                                                                                         
 Risk. Regulatory agencies may require us to demonstrate incremental benefit of the investigational 
 agent when added to an approved therapy. This can raise the evidentiary bar, necessitating         
 larger, more complex, and costlier clinical trials. There can be no assurance that our studies     
 will meet such requirements or result in regulatory approval.                                      |

| ● | Commercial                                                                                       
 Risk. The market acceptance of a combination therapy