Company: ACHV
Filing Date: 2025-05-13
Form Type: 10-Q
Source: 0000950170-25-069806
Chunk: 3

Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-05-13
Form: 10-Q
Item: Part I, Item 2
Chunk 3
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 nearly two decades aimed at aiding individuals in overcoming nicotine dependence. We believe cytisinicline is differentiated from existing smoking cessation treatments given its combination of efficacy, well-tolerated safety profile, and a shorter therapy duration, as demonstrated in clinical trials.

We have no products approved for commercial sale and have not generated any revenue from product sales to date. We have never been profitable and have incurred operating losses in each year since inception. Our net loss was $12.8 million for the three months ended March 31, 2025. As of March 31, 2025, we had an accumulated deficit of $218.4 million, cash, cash equivalents and marketable securities balance of $23.2 million and a positive working capital balance of $17.9 million. For the three months ended March 31, 2025, net cash used in operating activities was $11.1 million.

Substantial doubt exists as to our ability to continue as a going concern. Our ability to continue as a going concern is subject to material uncertainty and dependent on our ability to obtain additional financing. For additional information, see the section titled “—Liquidity, Capital Resources and Going Concern.”

Cytisinicline Regulatory Progress

Smoking Cessation 

In the fourth quarter of 2023, we initiated our pre-NDA discussions with the FDA regarding the adequacy of our efficacy and safety information for proceeding with an NDA submission. The FDA expressed support for an NDA submission based on adequate efficacy data from our two completed randomized and controlled Phase 3 trials. In addition, the FDA advised that long-term exposure data beyond 12 weeks would be needed to adequately assess safety risks given that the FDA views smoking cessation drugs as products for chronic, repeated, and intermittent use as patients may relapse and require subsequent courses of treatment over a lifetime. In the first quarter of 2024, we reached agreement with the FDA that a single, open-label study evaluating the long-term safety effects of cytisinicline will be sufficient to complete the requirement and enable an NDA submission anticipated in the second quarter of 2025. This study was initiated in May 2024, as discussed further below. We plan to submit the cytisinicline NDA to the FDA in June 2025. 

Vaping Cessation