Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 34

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 34
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. If any of these events occur, then we face the potential of losing control over valuable company
information, which could negatively affect our competitive position.

We may be unable to secure new patent protection for our LPLT-based immunization platform approach through additional patent applications, or may receive only partial claim approvals, which could limit the scope of intellectual property protection.

The one U.S. patent referenced relating to
the proprietary lipid-based delivery system developed in Prof. Barenholz’s laboratory at the Hebrew University of Jerusalem is
scheduled to expire on February 2027. This patent protect the composition and method of use of a liposomal nanoparticle platform incorporating
ceramide carbamoyl spermine (CCS) for the delivery of recombinant protein antigens in vaccine formulations. It includes composition of
matter claims and methods of use for prophylactic and therapeutic immunization.

This delivery system we are developing is
designed to optimize antigen presentation, enhance mucosal and systemic immunogenicity, and improve stability of co-encapsulated recombinant
proteins, as exemplified in preclinical studies involving SARS-CoV-2 and West Nile Virus (WNV) antigens. These studies showed promising
immunogenicity and protection outcomes in rodent models, however this neds to be further verified by future clinical trials.

<div align='center'>17</div>

As the Company advances its understanding
of the platform’s performance, it is preparing to file new patent applications covering the co-encapsulation of specific protein
combinations targeting additional viruses, including SARS-CoV-2 and West Nile Virus (WNV). The new patent applications will focus on
the antigen-specific compositions and immunization methods that are not covered by the original CCS delivery platform patents. These
applications are expected to be submitted following completion and internal review of the final reports from both the West Nile Virus
and SARS-CoV-2 preclinical proof-of-concept and challenge studies. These studies are designed to validate the underlying platform and
antigen design strategy and are currently being finalized by Prof. Barenholz’s team. Filings are anticipated by Q2 2026. The key
remaining milestones include: (i) completion and analysis of the SARS-CoV-2 challenge study dataset, and (ii) drafting of patent claims
specific to each antigen formulation.

The upcoming expiration of our current patent
poses a risk to our ability to protect the lipid-based vaccine delivery technology in its original form