Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 29

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 29
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 anti-cancer therapy adjunct are used in the manufacturing of a well-known chemotherapy agent Doxil®. While pre-clinical research
regarding the use of these candidates did not point out serious harmful effects, we cannot predict if this outcome will continue to be
true or whether possible adverse side effects directly attributable to our product candidates will be effective or safe 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 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. Del