Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 125

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 125
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 release systems, present
potential competition. These technologies aim to enhance the selective accumulation and controlled release of therapeutics within the
TME, which is a key feature of our liposomal ARB formulation.

Furthermore, the use of angiotensin receptor
blockers (ARBs) in cancer therapy, while innovative, is not exclusive to our company. Research institutions and pharmaceutical companies
are investigating the repurposing of ARBs and other similar agents for oncological applications, given their potential anti-tumor effects.
This could lead to direct competition with our ARB product candidate, especially if these entities develop formulations or combinations
that demonstrate superior efficacy or safety profiles. However, while other methods of delivering ARBs orally or intravenously may lower
blood pressure, making them unsuitable for a large portion of cancer patients, the liposomal ARB has been demonstrated in animal models
to be safe without reducing blood pressure. This allows for its potential administration in a safe and efficacious manner.

The competitive landscape in oncology 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 ARB product candidate.

While our proprietary Liposomal Protein-Loaded
Technology and the innovative use of ARB for TME normalization present a unique approach to cancer therapy, we acknowledge the presence
of significant competition from existing and forthcoming technologies aimed at improving the treatment of solid tumors. Our success will
depend on our ability to demonstrate superior efficacy, safety, and patient outcomes compared to these competing therapies.

Competition related to the novel vaccination platform LPTP

The global race to develop effective vaccines
against Coronavirus has led to a highly competitive environment, with numerous pharmaceutical companies, biotech firms, and academic
institutions actively engaged in the creation of a variety of vaccine platforms. These include mRNA vaccines, viral vector vaccines,
protein subunit vaccines, and inactivated virus vaccines, among others. Each of these platforms has its own set of advantages and challenges,
particularly in terms of efficacy, safety, storage requirements, and ease of distribution.

Our liposomal booster vaccine, leveraging proprietary
Liposomal Protein-Loaded Technology, faces competition from several established and emerging vaccine technologies. Notably, mRNA vaccines
from companies like Pfizer-BioNTech and Moderna have received widespread approval and adoption due to their high efficacy rates and relatively
rapid development timelines. However, limitations related to cold-chain storage, distribution