Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 17

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 17
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 patent prosecution and maintenance.

Clinical drug development and trials involve a lengthy and expensive process with an unpredictable outcome, especially human trials. We cannot be certain the results we observed in our pre-clinical testing will be confirmed in clinical trials or the results of any of our clinical trials will support FDA approval.

Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical study process. Positive results achieved in preclinical or early-stage clinical trials may not indicate the same positive results in later stage trials, or in trials with more patients. If positive results obtained in early-stage clinical trials are not achieved in later stage trials, pharmaceutical and biotechnology companies suffer significant setbacks. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses. There is a high failure rate for drugs proceeding through clinical studies, and product candidates in later stages of clinical studies may fail to show the desired safety and efficacy traits despite having progressed satisfactorily through preclinical studies and initial clinical studies. Not only are commercialization timelines pushed back, but some companies, particularly smaller biotechnology companies with limited cash reserves, have discontinued business after releasing news of 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.

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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.

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

Our current nanoparticles based novel antibiotic