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

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 25
---
 key-man insurance
on the life of, any of our directors or officers. The unexpected loss of the services of one or more of our directors or officers could
have a detrimental effect on us.

<div align='center'>11</div>

The competitive landscape is highly dynamic, with continuous advancements in science and technology leading to the emergence of novel therapeutic modalities. Regulatory approvals, strategic partnerships, and market adoption of competing therapies could significantly impact the commercial potential of our novel product candidates.

Conducting clinical trials for our drug-product
candidates involves inherent risks, including recruitment challenges, safety concerns, and demonstrating efficacy. Despite efforts to
optimize safety profiles, there is always a risk of adverse reactions or unexpected safety issues emerging during clinical trials or
after drug approval, especially when targeting complex biological pathways such as the Angiotensin Receptor Blocker System (ARB) or LTLP-based
vaccines. For instance, while preclinical studies may show promising results, there is no guarantee that our novel ARB-based candidate
will demonstrate sufficient efficacy in human populations. Tumor heterogeneity can impact the response to treatment, with variability
in drug sensitivity and resistance among different cancer cells and microenvironments. This may affect the effectiveness of ARB in achieving
TME (Tumor Microenvironment) normalization. In addition, cancer cells can develop resistance to treatments over time. Adaptive responses
within the TME may also counteract the effects of ARB-based therapy, limiting their long-term efficacy. Scaling up production of ARB-based
therapies can be complex and costly, with potential issues related to manufacturing consistency, quality control, and supply chain management.

Obtaining regulatory approval for our drug-product
candidates requires rigorous evaluation of safety, efficacy, and manufacturing processes, with no guarantee of successful registration.
The pharmaceutical market is highly competitive, with numerous approved and investigational products. Gaining market access and competing
with established treatments pose challenges for new therapy candidates. High development costs and uncertainties regarding reimbursement
for new therapies may impact the potential commercial viability of our product candidates, if approved, particularly in healthcare systems
with stringent cost-effectiveness criteria.

We are increasingly dependent on information technology, and our systems and infrastructure face certain risks, including cybersecurity and data leakage risks.

Significant disruptions to our information technology
systems or breaches of information security could adversely affect our business. While conducting Clinical Trails, we may collect, store
and transmit large amounts of confidential information, and it is critical that we do so in a secure manner to maintain the confidentiality