Company: RVRC
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-013823
Chunk: 18

Company: Revium Rx.
Filing Date: 2025-02-14
Form: S-1
Chunk 18
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 and anti-cancer therapy adjuvant are used in the manufacturing of a well-known chemotherapy agent Doxil®. While pre-clinical research regarding the use of this candidates did not point out at serious harmful effects, we cannot predict if this outcome will continue to be true or whether possible adverse side effects directly attributable to the candidates and will compromise their safety profile when used in certain combination therapies. In some instances, clinical results may not clearly indicate whether possible adverse effects are related to our technology versus other study related factors.

Conducting clinical trials for systemic antibiotics involves inherent risks, safety concerns, and regulatory requirements for demonstrating efficacy in treating bacterial infections.

Despite efforts to optimize safety profiles, there is always a risk of adverse reactions or unexpected safety issues emerging during clinical trials or after drug approval. While preclinical studies may show promising results, there is no guarantee that the antibiotic will demonstrate sufficient efficacy in human populations, especially against complex infections and resistant bacteria.

There is a risk that bacteria may develop resistance to the novel formulation of the antibiotic over time, potentially limiting its long-term effectiveness and necessitating the development of additional treatments. We also face manufacturing and scale-up challenges, since scaling up production of nanoparticles-based antibiotics can be complex and costly, with potential issues related to manufacturing consistency, quality control, and supply chain management. In addition, obtaining regulatory approval for a new antibiotic requires rigorous evaluation of safety, efficacy, and manufacturing processes, with no guarantee of successful registration. The antibiotic market is highly competitive, with numerous approved and investigational products. Gaining market access and competing with established antibiotics pose challenges for new entrants. Public health policies and antibiotic stewardship initiatives may impact the adoption and use of new antibiotics, influencing market demand and reimbursement considerations.

The competitive landscape is highly dynamic, with continuous advancements in science and technology leading to the emergence of novel therapeutic modalities. Regulatory approvals, strategic partnerships, and market adoption of competing therapies could significantly impact the commercial potential of our novel anti-cancer therapy adjuvant product candidate.

Conducting clinical trials for cancer therapy adjuvants involves inherent risks, including recruitment challenges, safety concerns, and demonstrating efficacy in combination with standard cancer treatments. Despite efforts to optimize safety profiles, there is always a risk of adverse reactions or unexpected safety issues emerging during clinical trials or after drug approval, especially when targeting complex biological pathways such as the Angiotensin Receptor Blocker System (ARB). While preclinical studies may show promising results, there is no guarantee that the ARB novel adjuvant will demonstrate sufficient efficacy in