Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 94

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 94
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 - | Initial studies with                                                                            
 candesartan liposomes (25% HPCD formulation) showed no reduction in MBP, similar to the results 
 obtained for valsartan formulations.                                                            |

| ● | IP protection:                                                                            
 ARB approach is patent pending. The below table summarizes the project related IP estate. |

| FIG. Mouse blood pressure (mmHg) after                                                                             
 free valsartan or liposomal valsartan (25 mg/kg) administration as determined using blood pressure monitor device. |

Title: Liposomal Formulations Comprising AT1 Receptor Blockers (ARB) and Uses Thereof

(Composition matter and use claimed)

| ** | Note:                                                                                     
 this application was abandoned and divisional application in CN was filed. The divisional 
 has not been published yet (as                                                            
 of May 5th, 2025)                                                                         |

<div align='center'>58</div>

We plan to generate additional evidence supporting
the efficacy and safety of the novel ARB formulation and to conduct further preclinical development, including animal studies in order
to evaluate its therapeutic potential.

The Company is currently planning to conduct
a dose-dependent study to evaluate the effect of the lead formulation on blood pressure in large animals. The results of this study will
shape the next phase of preclinical activities.

Following the large animal studies, we plan
to undertake a series of IND-enabling preclinical studies. These include therapeutic efficacy testing of the lead formulation in chosen
cancer models to assess its anti-cancer activity. Preliminary pharmacokinetics and tumor biodistribution studies in mice will be performed
to understand the absorption, distribution, metabolism, and excretion of the drug, as well as its accumulation in tumors. Concurrently,
bioanalytical methods will be developed and validated to quantify the drug and its metabolites in biological samples.

The Company will also scale up the manufacturing
process from lab scale to pilot scale, ensuring consistency in the formulation. Stability studies will follow, involving the development
of analytical methods to monitor stability and the performance of long-term and accelerated stability tests to define the shelf life
and storage conditions of the lead formulation. Additionally, toxicity and toxicokinetic studies in rats will assess the safety of the
formulation at clinically relevant doses, establishing the No Observed Adverse Effect Level (NOAEL).

In this way, management expects that the Company
will be able to ensure readiness for submission of an IND application with the FDA and preparedness for clinical trials, presenting