Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 123

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 123
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 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 dual approach ensures a thorough characterization
of Nano-Mupirocin, laying the groundwork for successful clinical development and regulatory submission.

The Phase 1 activities planned to commence
Q1 2026, will prepare for and execute the initial clinical study to assess the safety, tolerability, and pharmacokinetics of Nano-Mupirocin.
A clinical trial protocol document is now being finalized by us, outlining the study’s objectives, design, endpoints, and methodologies.
Regulatory submission already made to the Ministry of Health (MOH) in Israel in September 2025, while pre-Investigational New Drug (pre-IND)
meeting with the FDA is planned to be conducted Q2 2026.

Management anticipates that the Phase 1 clinical
trial will be initiated in Israel and/or or Europe, depending on regulatory and logistical considerations. The study will involve healthy
volunteers or patients and will evaluate the safety, tolerability, and pharmacokinetics of Nano-Mupirocin. Once the trial is complete,
the data will be analyzed to assess the drug’s pharmacokinetic and other relevant profiles. The findings will guide the next steps
in clinical development and inform strategies for subsequent studies.

Management believes that this comprehensive plan
is designed to ensure that Nano-Mupirocin progresses systematically through manufacturing and clinical evaluation, adhering to regulatory
standards and providing the necessary data to support further development.

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