Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 163

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 163
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505(b)(1) pathway. However, the FDA must agree with our assessment,
and there can be no assurance that the 505(b)(2) pathway will be accepted or sufficient for approval.

For our oncology combination therapy program,
we may decide 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 need for new treatment strategies,
Nano-Candesartan is being evaluated as a potential therapy. We may prioritize regulatory
discussions in the United States and Europe and may seek Orphan Drug Designation for oncology
indications such as pancreatic cancer. Any such designation is subject to regulatory discretion,
and there can be no assurance that it will be granted or that it will provide the anticipated
benefits. See Description of Business, Our Second Lead Candidate, Nano-Candesartan (nanoparticles-based ARB), is targeted for combination therapy with an initial indication in pancreatic ductal adenocarcinoma(PDAC) for a discussion of a disagreement between us and Yissum
as to our rights to the nano-cadesartan license.

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 may seek Orphan Medicinal Product Designation (OMPD) for Liposomal-ARB under Regulation
(EC) No 141/2000. To qualify, we may 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