Company: ACHV
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001193125-25-268074
Chunk: 3

Company: ACHIEVE LIFE SCIENCES, INC.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 2
Chunk 3
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 receptors in the brain by reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine dependence. In September 2025, we announced that the FDA accepted for review our NDA for cytisinicline as a treatment for smoking cessation as the first indication in the United States and assigned a Prescription Drug User Fee Act, or PDUFA, targeted action date of June 20, 2026.

We believe cytisinicline represents a unique opportunity to significantly impact global health by addressing the considerable unmet 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 potential option for a shorter therapy duration as compared to existing prescription smoking cessation therapies, 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 $40.0 million for the nine months ended September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $245.6 million, cash, cash equivalents and marketable securities balance of $48.1 million and a positive working capital balance of $40.3 million. For the nine months ended September 30, 2025, net cash used in operating activities was $31.5 million.

Substantial doubt exists as to our ability to continue as a going concern. Our ability to