Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 165

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 165
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(TME). Candesartan has been shown to reduce tumor-associated fibrosis, lower interstitial pressure, and normalize abnormal tumor vasculature—mechanisms
that enhance the intratumoral delivery and efficacy of co-administered therapies such as chemotherapy and immune checkpoint inhibitors.

Encapsulation of candesartan in nano-liposomes
enables targeted delivery to tumor tissue, prolongs circulation time, and significantly reduces systemic exposure and side effects, such
as hypotension. This targeted approach enhances the drug’s therapeutic index and supports its repurposing for oncology indications,
including hard-to-treat cancers like pancreatic adenocarcinoma.

We believe that the 505(b)(2) pathway may
be scientifically and strategically appropriate for this product, subject to FDA discretion. This pathway could potentially permit reliance
on established safety and pharmacology data from the reference listed drug (Atacand), while requiring us to generate new data specific
to the novel liposomal formulation and its intended oncology use. This approach may help streamline development timelines, may reduce
costs, and could potentially accelerate market entry compared to the 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.

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,