Company: ARTL
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001640334-25-001429
Chunk: 175

Company: ARTELO BIOSCIENCES, INC.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 2
Chunk 175
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 our current business focus and operations in pharmaceutical development began in 2017. We do not currently have the ability to perform all the functions necessary to develop and commercialize any product candidates. The successful development of any product candidates will require us to perform a variety of functions including, but not limited to:

·identifying, licensing and obtaining development programs and lead candidates; ·conducting initial research required to identify a lead candidate as the result of intellectual property we have licensed; ·initiating preclinical, clinical or other required studies for future product candidates; ·adding manufacturers and suppliers required to advance our programs; ·obtaining regulatory and marketing approvals for our product candidates that successfully complete clinical studies; ·making milestone or other payments under any license agreements; ·expanding, maintaining and protecting our intellectual property portfolio; ·attracting and retaining skilled personnel; and ·creating and maintaining an infrastructure required to support our operations as a public company.

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Our operations continue to be focused on acquiring, developing and securing our proprietary technology and undertaking pre-clinical and clinical trials of our products.

We expect our financial condition and operating results to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control. Upon approval of any of our product candidates, we will need to transition from a company with a research and development focus to a company capable of undertaking commercial activities. We may encounter unforeseen expenses, difficulties, complications and delays and may not be successful in such a transition.

We may experience delays in providing sufficient product for future testing of our candidates due to prior and any future supply chain limitations.

Due to prior and any future supply chain disruptions caused by COVID-19, or other pandemics, our contract manufacturing organizations may experience an inability to manufacture and produce sufficient quantities of our drug candidates as we progress through our regulatory testing and/or approval. Should this happen, we may not be able to provide sufficient quantities of our drug candidates to complete our testing as currently planned which could delay our ability to bring an approved drug to market. Such a delay may cause us to use more capital than currently planned which may have a material adverse effect on our projected timing of product approval and financials.

After submitting Investigational New Drug applications, the FDA may not permit us to proceed in a timely manner, or at all.

Prior to commencing clinical trials in territories with a regulatory authority we must obtain the necessary approvals to commence the clinical studies