Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 83

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 83
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 in systemic applications due to rapid degradation in blood. Through a PEGylated liposomal delivery
system, we believe that Nano-Mupirocin can be designed to achieve intracellular delivery, prolonged circulation time, and improve biodistribution
to the affected by the resistant bacterial tissue. This technology we are working to develop fills a critical therapeutic gap, particularly
for multidrug-resistant pathogens such as MRSA, VRE, rapidly emerging resistant pathogens of Gonorrhea, and others.

We believe that Nano-Mupirocin can address
the global Anti-Microbial Resistance (AMR) crisis by enabling highly potent systemic therapy for high-risk infections with limited existing
treatment options. The platform is being designed to offer improved affected tissue-selective delivery and intracellular access, unlike
current untargeted broad-spectrum antibiotics. We believe that our product candidate is being developed to establish a new therapeutic
standard and to potentially introduce a new class of liposomal anti-infective agents.

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Nano-Mupirocin technology overview

The nano-liposomal
formulation of Mupirocin is enhanced by adding hydroxypropyl-beta-cyclodextrin (HPCD) to the intraliposomal volume, allowing for Mupirocin
controlled release from the liposomes in blood. The novel Nano-Mupirocin’s efficacy has been demonstrated in various animal models,
with two of these studies sponsored by the National Institute of Health (US). Its pharmacokinetic profile in animal studies demonstrated
increased systemic exposure compared to the free drug, together with a substantially extended half-life. The in vitro spectrum
of activity for both Mupirocin and our liposomal Nano-Mupirocin was tested on many clinical isolates, showing no cross-resistance with
other antibiotics. Interestingly, similar Minimum Inhibitory Concentrations (MIC – the lowest concentration of the drug that inhibit
visible growth of a microorganism) were observed, indicating that Mupirocin remains active against bacteria while encapsulated in liposomes.
However, even if preclinical studies show promising results, there is no guarantee that such pharmaceutical candidate will demonstrate
sufficient efficacy or safety in human populations.

Additionally, Nano-Mupirocin was shown to
penetrate phagocytic cells and enhance the extermination of bacteria in vitro. Our internal data, which has not been independently verified,
suggests that our liposomal formulation has been well-tolerated in preclinical models.

The production