Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 29

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 29
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 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 large
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. 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.

We face Clinical Trial and other Challenges in Connection with the development of Product Candidates.

Conducting clinical trials for product 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 product candidate will demonstrate sufficient efficacy in human populations. Scaling up production for clinical trials
can be complex and costly, with potential issues related to manufacturing consistency, quality control, and supply chain disruptions.
Obtaining regulatory approval for a new drug requires rigorous evaluation of safety, efficacy, and manufacturing processes, with no guarantee
of success. Gaining market access and competing with established treatments pose challenges for new entrants. Individual variability
in treatment responses can impact efficacy. Delays, inconclusive results, or safety concerns could prevent or delay regulatory approval.
Even if early studies are encouraging, there can be no assurance that later-stage trials will confirm these results. Any such challenges
could materially and adversely affect our drug development programs, our overall business strategy, and our financial condition.

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We may not be successful in establishing and maintaining development and commercialization collaborations, which could