Company: ACHV
Filing Date: 2025-03-11
Form Type: 10-K
Source: 0000950170-25-036831
Chunk: 47

Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-03-11
Form: 10-K
Item: Item 1A
Chunk 47
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 that we will continue to incur losses for the foreseeable future.

We are a late-stage clinical specialty pharmaceutical company with a limited operating history, are not profitable, have incurred losses in each year since our inception and expect to continue incurring losses for the foreseeable future. 

Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We have devoted substantially all of our financial resources to developing our cytisinicline product candidate and supporting our operations. To date, we have funded the company primarily through the sale of equity securities and convertible promissory notes.

We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We further expect that our expenses will increase substantially if and as we:

•continue the clinical development of cytisinicline;

•establish a sales, marketing, and distribution infrastructure to commercialize cytisinicline;

•seek to attract and retain skilled personnel;

•undertake the manufacturing of cytisinicline or increase volumes manufactured by third parties;

•seek regulatory approvals and reimbursement for cytisinicline;

•experience delays in the development of our cytisinicline candidate, including delays in clinical trials and delays in regulatory review;

•initiate additional non-clinical, clinical, or other trials or studies for cytisinicline;

•make milestone, royalty or other payments under third-party license and/or supply agreements;

•seek to establish, maintain, protect, and expand our intellectual property portfolio;

•seek to discover, identify, assess, acquire, and/or develop other product candidates;

•encounter safety concerns; or

•require additional studies to support regulatory approval and commercialization.

Further, the net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.

We have never generated any revenue from product sales and may never be profitable.

We have no products approved for commercialization and have never generated any revenue from product sales. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaborators, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize cytisinicline. We do not anticipate generating revenue from product sales for the foreseeable future. Our ability to generate future revenue from product sales depends heavily on our success in many areas, including but not limited to:

•completing research and development of cytisinicline;

•obtaining regulatory approvals for cytisinicline