Company: ACHV
Filing Date: 2025-03-11
Form Type: 10-K
Source: 0000950170-25-036831
Chunk: 95

Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-03-11
Form: 10-K
Item: Item 1A
Chunk 95
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 the market price of our common stock to fluctuate include:

•our ability to raise additional capital, the terms of such capital, and our ability to continue as a going concern;

•the ability of us or our partners to develop cytisinicline and other product candidates and conduct clinical trials that demonstrate such product candidates are safe and effective;

•the ability of us or our partners to obtain regulatory approvals for cytisinicline or other product candidates, and delays or failures to obtain such approvals;

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•failure of any of our product candidates to demonstrate safety and efficacy, receive regulatory approval and achieve commercial success;

•the ability of us to establish a commercial infrastructure and complete other pre-commercialization and commercialization tasks to necessary to successfully commercialize cytisinicline should it be approved by the FDA;

•failure to maintain our existing third-party license, manufacturing and supply agreements;

•failure by us or our licensors to prosecute, maintain, or enforce our intellectual property rights;

•changes in laws or regulations applicable to our candidates;

•any inability to obtain adequate supply of product candidates or the inability to do so at acceptable prices;

•adverse regulatory authority decisions;

•introduction of new or competing products by our competitors;

•failure to meet or exceed financial and development projections we may provide to the public;

•the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;

•announcements of significant acquisitions, strategic partnerships, joint ventures, or capital commitments by us or our competitors;

•disputes or other developments relating to proprietary rights, including patents, litigation matters, and our ability to obtain intellectual property protection for our technologies;

•additions or departures of key personnel;

•significant lawsuits, including intellectual property or stockholder litigation;

•if securities or industry analysts do not publish research or reports about us, or if they issue an adverse or misleading opinion regarding our business and stock;

•changes in federal or global health policies, legislation or the review and oversight functions of federal health regulatory bodies;

•changes in the market valuations of similar companies;

•general market or macroeconomic conditions and geopolitical conditions, including fluctuating inflation, interest and tariff rates, increased volatility in the debt and equity markets, instability in the global banking system, global health crises and pandemics and geopolitical conflict, and their potentially material adverse impact on our business and the execution of our preclinical studies and clinical trials;

•sales of our common stock us or our stockholders in the future;

•trading volume of our common stock;

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