Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 156

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 156
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 generate new data specific to the novel liposomal formulation and its intended oncology use.
This approach streamlines development timelines, reduces costs, and accelerates market entry compared to the 505(b)(1) pathway.

For our oncology combination therapy program,
we plan to prioritize regulatory filings in the United States and Europe, with a phased expansion into Asia based on emerging data and
partnership opportunities.

Given the increasing incidence of therapy-resistant
cancers and the urgent demand for novel treatment strategies, Nano-Candesartan represents a clinically meaningful advancement. We are
prioritizing regulatory filings in the United States and Europe, with plans to seek Orphan Drug Designation for specific oncology indications
such as pancreatic cancer, where unmet need and limited therapeutic options justify regulatory incentives.

Europe

We intend to seek regulatory approval for
Liposomal-ARB through the European Medicines Agency (EMA) via the centralized marketing authorization procedure, which is mandatory for
all medicinal products designated as Orphan Medicinal Products and ensures simultaneous access across all EU member states.

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Given the poor prognosis and limited treatment
options associated with advanced pancreatic cancer, we plan to pursue Orphan Medicinal Product Designation (OMPD) for Liposomal-ARB under
Regulation (EC) No 141/2000. To qualify, we will provide:

| ● | Justification                                                                
 that pancreatic cancer affects fewer than 5 in 10,000 individuals in the EU. |

| ● | Evidence                                                                                    
 of the product’s potential significant benefit over existing treatments, such as FOLFIRINOX 
 or gemcitabine/nab-paclitaxel, particularly when used in combination regimens.              |

| ● | Data                                                                               
 supporting the drug’s unique mechanism of action, involving tumor microenvironment 
 normalization and improved drug penetration.                                       |

| ● | Upon                                                                           
 designation, we will benefit from a range of regulatory incentives, including: |

| ● | 10                                                   
 years of market exclusivity in the orphan indication |

| ● | Protocol                                                                                          
 assistance from the EMA, including scientific advice specifically tailored for orphan development |

| ● | Fee                                                                                       
 reductions for regulatory procedures (e.g., scientific advice, inspections, and marketing 
 authorization)                                                                            |

If interim or early clinical data demonstrate
compelling activity or address a critical unmet need, we will also evaluate eligibility for:

| ● | Conditional                                                                                     
 Marketing Authorization, allowing approval based on less comprehensive data if the benefit-risk