Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 113

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 113
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do not rely on public funding and continue to pursue multiple funding strategies to support our development programs. If we are unable
to successfully contract with third parties for development support, we may need to target less indications and/or raise additional funds
to continue advancing our product candidates.

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Manufacturing

Development plan and Chemistry, Manufacturing, and Controls (CMC)

CMC activities are centered on the development
of manufacturing methods, scaling up processes, and preparing Nano-Mupirocin for clinical trials. We do not own or operate, and currently
have no plans to establish, any manufacturing facilities.

We have engaged, and currently rely on, a
single third-party CMO, STA Pharmaceutical Hong Kong Limited, a Hong Kong corporation and an affiliated company of WuXi AppTec (HongKong),
for the supply of our product candidates for use in our preclinical studies and clinical trials. Should our CMO become unavailable to
us for any reason, we believe that there are a number of potential replacements, although we would incur delay and cost in identifying
and qualifying such replacements. We maintain a master services agreement with STA Pharmaceuticals pursuant to which it provides biologics
development and manufacturing services on a per-project basis. We may terminate the master services agreement at any time for convenience
in accordance with the terms of the agreement. The agreement includes confidentiality and intellectual property provisions to protect
our proprietary rights related to our product candidates. While any reduction or halt in supply from the CMO could limit our ability
to develop our product candidates until a replacement CMO is found and qualified, we believe that we have sufficient supply to support
our current clinical trial programs. See “Risk Factors” for additional information.

STA Pharmaceutical will develop the production
process, ensuring compliance with regulatory standards while effectively scaling up to produce clinical trial batches. The analytical
methods necessary for product characterization will be developed by STA Pharmaceutical under the close supervision of the Company’s
team and experienced consultants. These methods, which will be developed and validated, are intended to assess critical attributes of
the drug product, including potency, impurity levels, particle size distribution, and stability. They will form the foundation of quality
control and regulatory compliance efforts. Simultaneously, bioanalytical development will focus on advanced techniques for quantifying
Nano-Mupirocin and its metabolites in biological samples. Metabolite analysis, performed in collaboration with STA Pharmaceutical, will
provide deeper insights into the drug’s pharmacokinetics and metabolism. This