Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 105

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 105
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 study in Balb/c mice, conducted by Prof. Chezy Barenholz’s laboratory
at the Hebrew University, assessed immunogenicity, mucosal and systemic antibody titers, T-cell responses, viral clearance, and histopathology
following intranasal administration. Preliminary results demonstrated a favorable immunogenicity profile, including mucosal IgA and Th1-biased
T-cell responses, as well as reductions in viral titers and lung pathology in the treated groups.

The final report from this challenge and POC
studies are being conducted by the team of researchers from Prof. Barenholz’s lab. In parallel, a similar formulation targeting
WNV using the same CCS-based delivery system is being evaluated in vivo in rodents. These data are critical to validating the platform’s
modularity and supporting further development decisions, formulating potential intellectual property protection and devising a regulatory
strategy.

Next Steps:

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. | Initiate IND-enabling studies                                                                      
 for the selected candidate, including GLP toxicology and safety pharmacology studies in accordance 
 with FDA guidelines.                                                                               |

| 3. | Prepare a standard IND submission                                                                    
 for the chosen indication, with the goal of initiating a Phase 1 clinical trial focused on           
 safety and immunogenicity in healthy volunteers. The regulatory pathway will follow the conventional 
 phased development plan, with Phase 2 and Phase 3 trials to follow based on results.                 |

Contingent R&D Milestones (12–24 months):

| Milestone                                                  |     | Target Timeline   |
| Final report of challenge/POC studies (SARS-CoV-2 and WNV) |     | Q4 2025           |
| Internal review and candidate prioritization               |     | Q3–4 2025-Q1 2026 |
| IND-enabling GLP studies initiation                        |     | Q23-4 2026        |
| GMP manufacturing + Pre-IND submission (standard pathway)  |     | Q1-Q4 2027        |
| Phase 1 trial initiation (pending IND clearance)           |     | Q2 2028           |

Given the novel nature of the CCS-based delivery
system and