Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 112

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 112
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apsulation of specific protein combinations targeting additional
viruses, beyond SARS-CoV-2 and WNV. The new patent applications will focus on the antigen-specific compositions designed for each selected
virus. These applications are expected to be submitted following completion and internal review of the final reports from both the West
Nile Virus (WNV) and SARS-CoV-2 preclinical proof-of-concept and challenge studies. The key remaining milestones include: (i) completion
and analysis of both short and long-term SARS-CoV-2 challenge study dataset, and (ii) drafting of patent claims specific to each antigen
formulation.

There can be no assurance that these applications
will result in issued patents, that any patents granted will provide meaningful protection, or that they will not be challenged by third
parties.

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Current Stage of Development

The vaccine candidates have completed initial
preclinical proof-of-concept studies in rodent models. A short-term challenge study in BALB/c mice, conducted by Prof. Barenholz’s
team at specialized BSL-3 unit, assessed immunogenicity, mucosal and systemic antibody titers, T-cell responses, viral clearance, and
histopathology following intranasal administration. Preliminary results suggested a favorable immunogenicity profile, including mucosal
IgA and T-cell responses, as well as potential reductions in viral load and lung injury in the treated groups. Of course, there can be
no assurance that these features will be demonstrated in clinical studies or translate into meaningful treatment outcomes.

A long-term proof-of-concept (POC) challenge
study using the SARS-CoV-2 virus is planned to be completed Q1 2026. In addition, a similar formulation targeting WNV using the same
lipid-based delivery system is being evaluated in rodents. These data sets are critical for assessing the platform’s modularity
and will help guide further development decisions, inform potential intellectual property filings, and support the design of our regulatory
strategy.

24 Months Development Plan

Upon receipt and internal review of the final
challenge study reports, the Company plans to:

| 1. | Evaluate go/no-go decision                                                                                                 
 for advancement of either the SARS-CoV-2 or WNV vaccine candidate based on immunological outcomes and strategic alignment. |

| 2. | In the event a decision                                                                                                             
 is made to advance development, we intend to initiate IND-enabling studies for the