Company: ARTL
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0001640334-25-000825
Chunk: 231

Company: ARTELO BIOSCIENCES, INC.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 2
Chunk 231
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 on our preclinical data may prove inaccurate. Frequently, pharmaceutical and biotechnology companies have suffered significant setbacks in clinical trials after achieving positive results in preclinical testing and early clinical trials, and we cannot be certain that we will not face similar setbacks. These setbacks may be caused by the fact that preclinical and clinical data can be susceptible to varying interpretations and analyses. Furthermore, certain product candidates performed satisfactorily in preclinical studies and clinical trials, but nonetheless failed to obtain FDA approval or a marketing authorization granted by the European Commission. If we fail to produce positive results in our clinical trials for our product candidates, the development timeline and regulatory approval and commercialization prospects for them and as a result our business and financial prospects, would be materially adversely affected.

Clinical trials of lipid-signaling modulators and cannabinoid-based product candidates are novel with very limited or non-existing history; we face a significant risk that the trials will not result in commercially viable products and treatments.

At present, there is only a very limited documented clinical trial history related to lipid-signaling modulators and cannabinoids from which we can derive any scientific conclusions or prove that our present assumptions for the current and planned research are scientifically compelling. While we are encouraged by the limited results of clinical trials by others, there can be no assurance that any clinical trial will result in commercially viable products or treatments.

Clinical trials are expensive, time consuming and difficult to design and implement. We, as well as the regulatory authorities, may suspend, delay, or terminate our clinical trials at any time, may require us, for various reasons, to conduct additional clinical trials, or may require a particular clinical trial to continue for a longer duration than originally planned, including, among others:

·lack of effectiveness of any formulation or delivery system during clinical trials;   ·discovery of serious or unexpected toxicities or side effects experienced by trial participants or other safety issues; ·slower than expected rates of subject recruitment and enrollment rates in clinical trials; ·delays or inability in manufacturing or obtaining sufficient quantities of materials for use in clinical trials due to regulatory and manufacturing constraints; ·delays in obtaining regulatory authorization to commence a trial, including IRB or Ethics Committee approvals, licenses required for obtaining and using cannabinoids for research, either before or after a trial is commenced; ·unfavorable results from ongoing non-clinical studies and clinical trials; ·patients or investigators failing to comply with study protocols; ·patients failing to return for post-treatment follow-up at the expected rate; ·