Company: RVRC
Filing Date: 2025-12-12
Form Type: S-1/A
Source: 0001213900-25-121070
Chunk: 101

Company: Revium Rx.
Filing Date: 2025-12-12
Form: S-1/A
Chunk 101
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 clinical trials will demonstrate an acceptable
safety profile, that the product will be tolerated in patients, or that it will show clinically significant results.

To strengthen translational relevance, we plan
to conduct a dose-dependent study to evaluate the effect of the lead formulation on blood pressure in large animals. This program will
include detailed evaluation of multiple safety and pharmacological parameters relevant to intravenous administration, thereby informing
the clinical development pathway.

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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 also intends to 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.

In this way, management expects that the Company
will be able to proceed with submission of an IND application with the FDA and preparedness for clinical trials, subject to raising additional
capital. In the event that results from large-animal studies are supportive, we anticipate initiating clinical trials in the second half
of 2027.

We believe that combination therapy may offer
potential advantages beyond clinical performance. Because Nano-Candesartan may be paired with more than one class of established therapies,
the platform has the potential to enable collaborations with multiple pharmaceutical companies. This flexibility may create opportunities
for strategic partnerships and broaden the commercial applicability of the program.

However, developing a drug as part of a combination
regimen introduces unique complexities compared to monotherapy. In clinical development, combinations must demonstrate not only the safety
and efficacy of the investigational product itself, but also its added value beyond existing standards of care. This requires larger
and more complex trial designs, often involving multiple treatment arms to isolate the contribution of each agent. Regulatory agencies
may request mechanistic justification and additional data to ensure that the benefit is not solely attributable to the approved partner
drug.

From a marketing perspective, positioning a combination
therapy