Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 159

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 159
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 involved, and where liposomal delivery offers added benefit.

Focusing on these AMR-related orphan indications
supports a targeted clinical development plan with high unmet medical need, smaller trial sizes, and a strong alignment with public health
priorities. This also enhances the potential to access key regulatory incentives and pathways dedicated to antimicrobial resistance.

Expedited Regulatory Pathways and Potential Designations

We intend to evaluate and, where appropriate,
pursue various expedited development and review pathways provided by the U.S. Food and Drug Administration (FDA), including Orphan Drug
Designation (ODD), Breakthrough Therapy designation (BTD), Fast Track designation, and Priority Review, for certain of our product candidates
such as Nano-Mupirocin, Nano-Candesartan (as an ARB cancer therapy adjuvant), and our liposomal vaccine platform. These regulatory programs
are intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs.

Basis for Potential Eligibility:

Based on early-stage preclinical data and the
indications we are targeting, we believe that certain of our product candidates may meet the preliminary criteria for expedited development
programs. For example:

| ● | Nano-Mupirocin                                                                                                                       
 may be eligible for Fast Track designation or QIDP status due to its potential to address serious, multidrug-resistant Gram-positive 
 infections, including MRSA.                                                                                                          |

| ● | Nano-Candesartan                                                                                                                      
 may qualify for Breakthrough Therapy designation if future clinical data demonstrate substantial improvement over available therapies 
 in oncology settings. 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).                                        |

However, these beliefs are based on our current
development plans and nonclinical data, and actual eligibility for any FDA designation is subject to further evaluation by the FDA following
submission of the relevant data.

Limitations and Regulatory Uncertainty:

While these designations can provide potential
benefits, including more frequent interactions with the FDA, eligibility for rolling submissions, and in some cases shorter review timelines,
they do not guarantee a faster development or approval process. Moreover, they do not increase the likelihood that a product candidate
will ultimately receive marketing approval. Because our product candidates are in early stages of development, there can be no assurance
that the FDA will grant any such designation or