Company: RVRC
Filing Date: 2025-10-03
Form Type: S-1/A
Source: 0001213900-25-096094
Chunk: 28

Company: Revium Rx.
Filing Date: 2025-10-03
Form: S-1/A
Chunk 28
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 depends on the availability, pricing,       
 and reimbursement of the partner drug. If the partner drug is expensive, in short supply,        
 replaced by newer standards of care, or faces restricted reimbursement, the commercial potential 
 of our therapy could be materially reduced, regardless of our product’s clinical performance.    |

| ● | Intellectual                                                                                  
 Property and Partnering Risk. Use of off-patent or competitor-owned drugs in our combinations 
 may complicate exclusivity, licensing, and long-term value capture. We may be required to     
 obtain licenses or enter into collaborations to commercialize our therapies, and there can    
 be no assurance that such arrangements will be available on acceptable terms, if at all.      |

Any of these risks, individually or in the
aggregate, could materially and adversely affect our ability to advance this program and our overall business prospects.

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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, and increased costs.

Our LNP-based product candidates in Combination with Other Therapies may result in unexpected adverse effects, which could delay, limit, or prevent their development and commercialization.

Our current nanoparticles based novel antibiotic
and anti-cancer therapy adjunct are used in the manufacturing of a well-known chemotherapy agent Doxil®. While pre-clinical research
regarding the use of these candidates did not point out serious harmful effects, we cannot predict if this outcome will continue to be
true or whether possible adverse side effects directly attributable to our product candidates will be effective or safe when used in
certain combination therapies. In some instances, clinical results may not clearly