XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT

XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT

XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT

Form 8-K - Current report - Item 1.01 Item 7.01 Item 9.01

Achieve Life Sciences Inc.

Announcement: ACHV 8-K Special Filing

Form 8-K - Current report - Item 7.01 Item 8.01 Item 9.01

Form 8-K - Current report - Item 1.01 Item 2.03 Item 9.01

Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend]

Announcement: ACHV 10-K/A Special Filing Amendment

Part 1: Analysis of Performance

Achieve Life Sciences, Inc. is a company that is focused on developing and commercializing cytisinicline, a plant-based alkaloid that is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation. The company is addressing the global smoking health and nicotine addiction epidemic through this product. Achieve Life Sciences, Inc. has not generated any revenue from product sales to date, and it has never been profitable. The company has incurred operating losses in every year since its inception. Its net loss was $9.0 million for the three months ended March 31, 2023. The company's accumulated deficit as of March 31, 2023, was $144.9 million. It had a cash and cash equivalents balance of $16.5 million, which is insufficient to fund its planned operations for the next twelve months. The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues its clinical development of, and seeks regulatory approval for, cytisinicline. It expects that its operating losses will fluctuate significantly from quarter to quarter and year to year due to the timing of clinical development programs and efforts to achieve regulatory approval. 

In April 2022, Achieve Life Sciences, Inc. announced positive topline results for the Phase 3 ORCA-2 clinical trial. ORCA-2 evaluated the efficacy and safety of 3 mg cytisinicline dosed three times daily compared to placebo in 810 adult smokers at 17 clinical sites in the United States. ORCA-2 participants were randomized to one of three study arms to determine the smoking cessation efficacy and safety profile of cytisinicline when administered for either 6 or 12 weeks, compared to placebo. The results of the trial provide promising evidence for cytisinicline's potential as a smoking cessation aid, especially for those who have not had success with other cessation options. Overall, Achieve Life Sciences, Inc. is still in its early stages and has a lot of work to do in terms of gaining regulatory approval and commercializing its product. 

Part 2: Forward Looking Analysis

The global smoking health and nicotine addiction epidemic is a major problem that affects millions of people worldwide. Achieve Life Sciences, Inc.'s focus on developing cytisinicline to address this issue is a step in the right direction. However, the company's financial situation is not strong, and it will need to raise substantial additional capital to continue funding its operations. The amount and timing of its future funding requirements will depend on many factors, including the pace and results of its clinical development efforts. 

Achieve Life Sciences, Inc. operates in a highly competitive environment, and it will face competition from existing and potential new products targeting smoking cessation. Additionally, regulatory approval is critical to the company's success. The FDA approval process can be lengthy and costly, and any delays or hiccups in this process could have a negative impact on the company's financial condition and its ability to develop and commercialize its product. 

Recent trends in the industry, such as the increasing popularity of e-cigarettes among adolescents, highlight the need for effective cessation options. If approved, cytisinicline could fill a gap in the market by providing an FDA-approved treatment indicated specifically as an aid to nicotine e-cigarette cessation. 

Overall, Achieve Life Sciences, Inc. has significant potential for growth and success if it can obtain regulatory approval and commercialize its product successfully. However, the company's financial situation and the highly competitive environment it operates in create challenges. Investors should pay close attention to future developments, particularly regarding regulatory approval and the company's efforts to raise additional capital.

XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

Achieve Life Sciences: A Promising Smoking Cessation Aid?

Achieve Life Sciences, a late-stage pharmaceutical company, has reported its financial results for Q1 2023. As per the report, the company has successfully completed the last subject visit for its ongoing Phase 3 ORCA-3 trial and expects to report topline results in Q2 2023. Achieve is developing and commercializing cytisinicline, a plant-based alkaloid that aims to aid in treating nicotine addiction for smoking and e-cigarette cessation. The company's goal is to become the first new FDA-approved treatment for smoking cessation in nearly 20 years, and now with the ORCA-V1 trial results, the first treatment specifically indicated for e-cigarette cessation. 

The Phase 2 ORCA-V1 trial showed successful results, with trial participants who received 12 weeks of cytisinicline treatment having a vaping cessation rate of 31%, compared to 15% for the placebo group. The benefit was observed across clinical trial sites and demographics such as age, gender, race, and smoking history. Furthermore, additional analyses from the Phase-3 ORCA-2 trial were reported at the SRNT Annual Meeting, proving that successful smoking cessation was observed in subgroups of people who smoke that received cytisinicline.

The company has appointed three new directors, Mr. Stuart Duty, Mr. Thomas King, and Mr. Tom Sellig, to its Board of Directors, bringing extensive pharmaceutical and life sciences industry experience.

Overall, the financial report suggests that Achieve Life Sciences is making notable progress towards its goal of making cytisinicline a new treatment for smoking cessation. Investors can take note of the company's achievements in its ongoing Phase 3 trials and its potential to cater to a significant market with high unmet medical needs.

Form 8-K - Current report - Item 2.02 Item 9.01

Announcement: ACHV 8-K Special Filing

Announcement: ACHV 8-K Special Filing

Announcement: ACHV 8-K Special Filing

Announcement: ACHV 8-K Special Filing

Announcement: ACHV 8-K Special Filing

Announcement: ACHV 8-K Special Filing

Announcement: ACHV 10-K/A Special Filing Amendment

Announcement: ACHV 10-K/A Special Filing Amendment

Achieve Life Sciences: A Promising Smoking Cessation Aid?

Achieve Life Sciences: A Promising Smoking Cessation Aid?

$ACHV reports progress in Phase 3 ORCA-3 trial for smoking cessation treatment with cytisinicline

$ACHV reports progress in Phase 3 ORCA-3 trial for smoking cessation treatment with cytisinicline