Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 26

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 26
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protection while others may have suboptimal responses. Distributing vaccines, especially those requiring specific storage conditions
or administration routes, can pose logistical challenges, particularly in resource-limited settings. The evolution of new virus variants
may affect vaccine effectiveness, requiring ongoing monitoring and potential vaccine modifications.

We may be unable to secure new patent protection for our lipid-based vaccine delivery technology and 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 two U.S. patents referenced relating to
the proprietary lipid-based delivery system developed in Prof. Chezy Barenholz’s laboratory at the Hebrew University of Jerusalem
are scheduled to expire in July 2025 and February 2027, respectively. These patents 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.
They include 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 and demonstrated the platform’s modularity across viral targets.

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 WNV. The new patent applications will focus on the antigen-specific
compositions and immunization methods that are not covered by the original CCS delivery patents. 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. 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 Q4 2025. 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