Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 110

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 110
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 efficacy
in humans or that regulatory authorities will view them as sufficient for approval.

We are currently awaiting the completion of a
SARS-CoV-2 challenge study involving 114 ACE2-transgenic mice, conducted by Prof. Barenholz. It is expected to conclude in the first
quarter of 2026. The study is designed to evaluate the short- and long-term outcomes of the LPLT approach-based vaccination. The results
of the study are also intended to inform us of the provisional patent application that we are currently working on. The results of this
study are critical to determining the commercial viability of continued investment in this program. Prof. Barenholtz’s study was
scheduled to be completed in the third quarter of 2025 but has been delayed due to contamination of the specialized BSL-3 unit designed
for research of dangerous infectious agents that can be transmitted through the air and cause serious, potentially lethal disease.

The LPLT-based immunization platform is being
designed to:

| - | Significantly improve vaccines’                                                                        
 efficiency and be more durable than mRNA vaccines and, potentially, provide longer-lasting protection; |

| - | Provide broader cross-immunity         
 to protect against new virus variants; |

| - | Expected to boost the immune                                                                               
 system of people vaccinated with other vaccines as well as to effectively stop the spread of the pandemic; |

Recent animal studies conducted by Prof. Barenholz
suggest that the new LPLT technology may have the potential to induce immune responses and generate antibody levels in preclinical models.
This novel immunization approach is being evaluated for its ability to broaden immune protection, including potential effects on mucosal
immunity. Such effects, if confirmed, could be relevant in addressing viral mutations. However, these observations are limited to preclinical
models, and there can be no assurance that they will be replicated in clinical studies, result in meaningful patient outcomes, or be
considered sufficient by regulatory authorities for approval.

LPLT technology may potentially have several
advantages over the current methods of protein delivery. Firstly, this unique CCS drug-delivery technology is designed to protect the
proteins from degradation and clearance by the immune system or the liver, thus increasing their half-life and reducing the frequency
and dose of administration. Secondly, it can improve the biodistribution and accumulation of the proteins at the desired sites of action,
such as inflamed tissues, or infected cells, thus increasing their efficacy and reducing their side effects.

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