Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 79

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 79
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 potentially present significant advancement in antibiotic therapy by enabling systemic use of mupirocin, a potent topical antibiotic
previously ineffective in systemic applications due to rapid degradation in blood. Through a PEGylated liposomal delivery system, Nano-Mupirocin
achieves intracellular delivery, prolonged circulation time, and site-specific targeting of resistant bacterial infections. This technology
fills a critical therapeutic gap, particularly for multidrug-resistant pathogens such as MRSA, VRE, rapidly emerging resistant pathogens
of Gonorrhea, and others. The novelty lies not in a new molecule but in a promising therapeutic profile of delivery science and may offer
valuable and clinically significant novel therapeutic option.

Nano-Mupirocin addresses the global Anti-Microbial
Resistance (AMR) crisis by enabling targeted systemic therapy for high-risk infections with limited existing treatment options. The platform
offers precision delivery and intracellular access, unlike current broad-spectrum antibiotics. Our product candidate is being developed
to establish a new therapeutic standard and potentially introduce a new class of liposomal anti-infective agents. Our novel formulation
and approach are also expected to reduce off-target toxicity and be less harmful to microbiome integrity, while addressing critical unmet
clinical needs in hospital settings and in the management of resistant infections.

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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 such
studies sponsored by the National Institute of Health (US). Its pharmacokinetic profile in animal studies showed significantly higher
exposure compared to the free drug, along with a substantially prolonged half-life. The in vitro spectrum of activity for both
Mupirocin and Nano-Mupirocin was tested on many clinical isolates, showing no cross-resistance with other antibiotics. Interestingly,
similar MICs were observed, indicating that Mupirocin remains active against bacteria while encapsulated in liposomes.

Additionally, Nano-Mupirocin was shown to
penetrate phagocytic cells and enhance the extermination of bacteria. In addition to the safety data available for topical mupirocin—which
was originally developed as Bactroban® by GSK and has been approved for