Company: ARTL
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0001640334-25-001429
Chunk: 248

Company: ARTELO BIOSCIENCES, INC.
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 3
Chunk 248
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 become profitable depends significantly on our success in a number of areas.

We currently do not have any therapeutic products that are approved for commercial sale. We have not received and do not expect to receive for at least the next several years, if at all, any revenues from the commercialization of our product candidates, if approved in the future. To obtain revenues from sales of our product candidates that are significant or large enough to achieve profitability, we must succeed, either alone or with third parties, in developing, obtaining regulatory approval for, manufacturing and marketing therapies with commercial potential. Our ability to generate revenue and achieve profitability depends significantly on our success in many areas, including:

 ·our research and development efforts, including preclinical studies and clinical trials of our product candidates;    ·developing sustainable, scalable, reliable and cost-effective manufacturing and distribution processes for our product candidates, including establishing and maintaining commercially viable supply relationships with third parties and establishing our own cGMPs, manufacturing facilities and processes;    ·addressing any competing technological and industry developments;    ·identifying, assessing, acquiring and/or developing new technology platforms and product candidates across numerous therapeutic areas;    ·obtaining regulatory approvals and marketing authorizations for product candidates;    ·launching and commercializing any approved products, either directly or with a collaborator or distributor;    ·obtaining market acceptance of and acceptable reimbursement for any approved products;    ·completing collaborations, licenses and other strategic transactions on favorable terms, if at all;    ·maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and    ·attracting, hiring and retaining qualified personnel.

We have very limited operating history and capabilities.

Although our company was formed in 2011, 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;