Company: OSRH
Filing Date: 2025-01-29
Form Type: S-4/A
Source: 0001213900-25-007923
Chunk: 185

Company: OSR Holdings, Inc.
Filing Date: 2025-01-29
Form: S-4/A
Chunk 185
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 commercialize, our product candidates, including: •timely completion of our preclinical studies and clinical trials; •negative or inconclusive results from our preclinical studies or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional preclinical testing or clinical trials or abandon a program; •the prevalence, duration and severity of potential product -relatedside effects experienced by participants receiving our product candidates in our clinical trials or by individuals using drugs or therapeutics similar to our product candidates; •delays in submitting Investigational New Drug (“IND”) or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators to commence a clinical trial, or a suspension or termination of a clinical trial once commenced; •conditions imposed by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials; •delays in enrolling participants in clinical trials; •high drop -outrates of participants from clinical trials; •inadequate supply or quality of product candidates or other materials necessary for the conduct of our clinical trials; •greater than anticipated clinical trial costs; •inability to compete with other therapies; 98 •poor efficacy of our product candidates during clinical trials; •unfavorable FDA or other regulatory agency inspection and review of a clinical trial site; •failure of our third -partycontractors or investigators to comply with regulatory requirements or otherwise meet their contractual obligations in a timely manner, or at all; •delays related to the impact of recessions, man -madeand/or natural disasters, pandemics, and/or any other such events; •delays and changes in regulatory requirements, policy and guidelines, including the imposition of additional regulatory oversight around clinical testing generally or with respect to our technology in particular; or •varying interpretations of data by the FDA and similar foreign regulatory agencies. We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and our manufacturing, marketing, distribution and sales efforts or that of any future collaborator. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of any of our product candidates, which may adversely impact our results of operations and financial condition. We may experience delays in initiating or completing clinical trials. Clinical trials can be delayed or terminated for a variety of reasons, including: •regulators or institutional review boards (“ IRB”) or ethics committees may not authorize us or our investigators