Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 157

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 157
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 of the laws described above or any other government regulations that apply to us, we may
be subject to penalties, including significant civil and criminal penalties, damages, fines, exclusion from participation in government
healthcare programs, such as Medicare and Medicaid, imprisonment, and the curtailment or restructuring of our operations, any of which
could adversely affect our business, financial condition, results of operations, and prospects.

Nano-Mupirocin Regulatory Strategy

United States

We may seek FDA approval for Nano-Mupirocin under
the 505(b)(2) regulatory pathway, which is subject to FDA discretion, and there can be no assurance that this pathway will be available
or sufficient for approval. The 505(b)(2) pathway could potentially allow reliance on existing data for an approved active ingredient
while supporting innovation in formulation or route of administration. Mupirocin is currently approved in the U.S. as a topical antibiotic
(Bactroban) but is unsuitable for systemic use due to rapid metabolism and high protein binding..

Nano-Mupirocin is a novel liposomal formulation
being developed to enable parenteral administration of mupirocin (i.e., administration into the body by routes other than the intestines
or digestive tract), with the goal of evaluating its potential as a systemically active antibiotic. By encapsulating mupirocin in a liposomal
composition similar to that used in the FDA-approved product Doxil (liposomal doxorubicin), preclinical studies suggest that the drug
may be protected in the bloodstream and may exhibit altered bioavailability and antibacterial activity against serious and resistant
bacterial pathogens identified by the CDC. However, these observations are limited to preclinical models, and there can be no assurance
that such effects will be observed in humans, that they will result in clinical benefit, or that they will be sufficient for regulatory
approval..

While no assurance can be provided, we believe
that the 505(b)(2) pathway may provide an appropriate regulatory approach for this product, subject to FDA discretion, as it could allow
us to bridge existing data on both the active ingredient (mupirocin) and the well-characterized and FDA-approved liposomal delivery platform,
while generating new data specific to the systemic application of the formulation. This regulatory strategy may provide a scientifically
sound and capital-efficient path to approval and could potentially facilitate development of a critical new therapeutic in the context
of the growing global threat of antimicrobial resistance.

We believe that the 505(b