Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 24

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 24
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il®. While pre-clinical research
regarding the use of these candidates did not point out at serious harmful effects, we cannot predict if this outcome will continue to
be true or whether possible adverse side effects directly attributable to the candidates and will compromise their safety profile when
used in certain combination therapies. In some instances, clinical results may not clearly indicate whether possible adverse effects
are related to our technology versus other study related factors.

Conducting clinical trials for systemic antibiotics involves inherent risks, safety concerns, and regulatory requirements for demonstrating efficacy in treating bacterial infections.

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. While
preclinical studies may show promising results, there is no guarantee that the antibiotic will demonstrate sufficient efficacy in human
populations, especially against complex infections and resistant bacteria.

There is a risk that bacteria may develop resistance
to the novel formulation of the antibiotic over time, potentially limiting its long-term effectiveness and necessitating the development
of additional treatments. We also face manufacturing and scale-up challenges, since scaling up production of nanoparticles-based antibiotics
can be complex and costly, with potential issues related to manufacturing consistency, quality control, and supply chain management.
In addition, obtaining regulatory approval for a new antibiotic requires rigorous evaluation of safety, efficacy, and manufacturing processes,
with no guarantee of successful registration. The antibiotic market is highly competitive, with numerous approved and investigational
products. Gaining market access and competing with established antibiotics pose challenges for new entrants. Public health policies and
antibiotic stewardship initiatives may impact the adoption and use of new antibiotics, influencing market demand and reimbursement considerations.

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 anti-cancer adjunct therapy product candidate.

Conducting clinical trials for anti-cancer
adjunct therapy involves inherent risks, including recruitment challenges, safety concerns, and demonstrating efficacy in combination
with standard cancer treatments. 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). While preclinical studies may show promising results, there is no guarantee that our novel
ARB-based anti-cancer adjunct therapy will demonstrate sufficient efficacy in