Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 25

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 25
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 human populations, particularly in diverse cancer types
and patient 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 t 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 a new anti-cancer
combination therapy requires rigorous evaluation of safety, efficacy, and manufacturing processes, with no guarantee of successful registration.
The cancer therapy 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 anti-cancer combination therapies may impact the commercial viability of our novel adjunct therapy drug candidate , particularly
in healthcare systems with stringent cost-effectiveness criteria.

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We Face Clinical Trial and other Challenges in Connection with the development of a liposomal booster vaccine against CORONAVIRUS:

Conducting clinical trials for vaccine candidates
involves inherent risks, including recruitment challenges, regulatory hurdles, significant high development costs and unforeseen adverse
events in human subjects. Despite efforts to minimize side effects, there is always a risk of adverse reactions or unexpected safety
issues arising during clinical trials or after vaccine deployment. While preclinical studies may show promising results, there is no
guarantee that the vaccine will demonstrate sufficient efficacy in human populations, especially against emerging variants of the virus.
Scaling up production of liposomal vaccines can be complex and costly, with potential issues related to manufacturing consistency, quality
control, and supply chain disruptions. Obtaining regulatory approval for a new vaccine requires rigorous evaluation of safety, efficacy,
and manufacturing processes, with no guarantee of success. The CORONAVIRUS vaccine market is highly competitive, with numerous approved
and investigational products. Gaining market access and competing with established vaccines pose challenges for new entrants. Vaccine
hesitancy and public perception of new vaccines can influence acceptance rates and uptake, affecting overall effectiveness in controlling
the spread of the virus. Individual variability in immune response to vaccines can impact efficacy, with some individuals achieving robust