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

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 25
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 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 and integrity of such information. We also plan to outsource certain elements of our information technology infrastructure;
as a result, we manage independent vendor relationships with third parties who are responsible for maintaining significant elements of
our information technology systems and infrastructure and who may or could have access to our confidential information. The size and
complexity of our information technology systems, and those of our third-party vendors, make such systems potentially vulnerable to service
interruptions