Company: RVRC
Filing Date: 2025-08-13
Form Type: S-1/A
Source: 0001213900-25-075747
Chunk: 23

Company: Revium Rx.
Filing Date: 2025-08-13
Form: S-1/A
Chunk 23
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unsuccessful clinical trial results due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier
studies. If we experience unexpected, inconsistent or disappointing results in connection with a clinical or pre-clinical trial our business
will suffer. A delay in our pre-clinical research or our clinical trials, for any reason, will require us to spend additional funds to
keep our product(s) moving through the regulatory process.

<div align='center'>10</div>

In the event our pre-clinical
research or our clinical trials are not successful, we will have to determine whether to continue to fund our programs to address the
deficiencies, or whether to abandon our clinical development programs for our products in tested indications. Because there are so many
variables inherent in pre-clinical research or clinical trials, we cannot predict whether any of our future regulatory applications to
conduct clinical trials will be approved by the FDA or other regulatory authorities, whether our clinical trials will commence or proceed
as planned, whether any Phase I, Phase II, Phase III (if any) or other clinical studies we may conduct will demonstrate consistent or
adequate efficacy and safety sufficient to obtain regulatory approval to market our product candidates, and whether the trials will ultimately
be deemed to be successful.

We may seek expedited development or approval pathways for certain of our product candidates, but there is no assurance that such pathways will be granted or will accelerate clinical development or approval.

We may pursue expedited
development and regulatory programs offered by the FDA, including Fast Track, Breakthrough Therapy, Priority Review, and Orphan Drug
Designation for certain of our product candidates. These programs are intended to expedite the development and review of therapies that
target serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. However, there can be
no assurance that any of our current or future product candidates will qualify for or be granted any such designation. Even if a product
candidate receives one of these designations, it may not result in faster development or regulatory review, may be revoked later based
on clinical data, and does not increase the likelihood of regulatory approval. Failure to obtain or maintain any such designation could
result in a longer development timeline, increased costs, and reduced competitive advantage

Our LNP-based product candidates in Combination with Other Therapies May Result in Harmful Effects.

Our current nanoparticles based novel antibiotic
and anti-cancer therapy adjunct are used in the manufacturing of a well-known chemotherapy agent Dox