Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 114

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 114
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 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
by 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 are now being finalized by the Company, outlining the study’s objectives, design, endpoints,
and methodologies. Regulatory submissions are planned to be made to the Ministry of Health (MOH) in Israel by October 2025, while pre-Investigational
New Drug (pre-IND) submissions and meetings with the FDA are planned to be conducted Q2-3 2026.

Management anticipates that the Phase 1 clinical
trial will be initiated in Israel and/or the US 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 safety and pharmacokinetic 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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Competition

The pharmaceutical
industry is characterized by rapidly advancing technologies and intense competition and a strong emphasis on proprietary drugs. While
we believe that our knowledge, experience and scientific resources provide us with competitive advantages, we face potential competition
from many different sources, including large and specialty pharmaceutical and biotechnology companies, academic research institutions
and governmental agencies, as well as public and private research institutions. Any product candidates that we successfully develop and
commercialize, if approved, will compete with existing therapies and new therapies that may become available in the future.

The key competitive
factors affecting the success of all of our product candidates, if approved, are likely to be their safety, efficacy, convenience, price,
the level of generic competition, the existence of therapeutic alternatives and the availability of coverage and reimbursement from government
and other third-party payors.

Many of our competitors
have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting
clinical trials, obtaining regulatory approvals and marketing approved drugs than we do