Company: ARTL
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001640334-25-001429
Chunk: 85

Company: ARTELO BIOSCIENCES, INC.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part II, Item 1A
Chunk 85
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 early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. There is a high failure rate for drugs proceeding through clinical trials, and product candidates in later stages of clinical trials may fail to show the required safety and efficacy despite having progressed through preclinical studies and initial clinical trials. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier clinical trials, and we cannot be certain that we will not face similar setbacks. Even if our clinical trials are completed, the results may not be sufficient to support obtaining regulatory approval for our product candidates.

We do not know whether future clinical trials, if any, will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all. Clinical trials can be delayed, suspended or terminated by us, regulatory authorities, clinical trial investigators, and ethics committees for a variety of reasons, including failure to:

·generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials; ·obtain regulatory approval, or feedback on clinical trial design, to commence a clinical trial; ·identify, recruit and train suitable clinical investigators; ·reach agreement on acceptable terms with prospective CROs and clinical trial sites; ·obtain and maintain IRB, approval at each clinical trial site; ·identify, recruit, and enroll suitable patients to participate in a clinical trial; ·have a sufficient number of patients complete a clinical trial or return for post-treatment follow-up; ·ensure clinical investigators observe clinical trial protocol or continue to participate in a clinical trial; ·address any patient safety concerns that arise during the course of a clinical trial; ·address any conflicts with new or existing laws or regulations; ·add a sufficient number of clinical trial sites; ·timely manufacture sufficient quantities of a product candidate for use in clinical trials; or ·raise sufficient capital to fund a clinical trial.

Patient enrollment is a significant factor in the timing of clinical trials and is affected by many factors, including the size and nature of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the clinical trial, the design of the clinical trial, competing clinical trials and clinicians’ and patients’ or caregivers’ perceptions as to the potential advantages of the drug candidate being studied in relation to other available therapies, including any new drugs or treatments