Company: ACHV
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0000950170-25-104571
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Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 2
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met need among millions of smokers and e-cigarettes users. If approved by the FDA, it may become one of the first new prescription medicines in 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.

If approved, we plan to commence commercial sales of cytisinicline in the United States in the second half of 2026. We believe we will be able to commercialize independently in the U.S. market by focusing our marketing and sales efforts on highly targeted prescriber and patient audiences. We are planning to launch by utilizing a well-established marketing technology infrastructure and embedding AI tools to enhance targeting, decision making, and performance metrics. Launch planning and readiness activities are underway, leveraging our integrated agency partnership with Omnicom, with teams established for key functional areas including market access, medical education, prescriber and patient marketing, and digital infrastructure. Additionally, field-based and virtual sales representatives will supplement digital promotional efforts. 

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 $25.5 million for the six months ended June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $231.1 million, cash, cash equivalents and marketable securities balance of $55.4 million and a positive working capital balance of $48.3 million. For the six months ended June 30, 2025, net cash used in operating activities was $20.2 million.

Cytisinicline Regulatory Progress

Smoking Cessation 

In June 2025, we announced the submission of an NDA with the FDA for cytisinicline as a treatment of nicotine dependence for smoking cessation in adults. The cytisinicline NDA is supported by a combination of efficacy and well-tolerated safety results from two large, placebo-controlled Phase 3 trials, ORCA-2 and ORCA-3, which evaluated cytisinicline for smoking cessation. In both studies, cytisinicline administered for either 6 or 12 weeks, alongside standard behavioral support, demonstrated significantly greater abstinence rates by the end of treatment and in long-term abstinence through week 24 compared to placebo. We also included safety data on