Achieve Life Sciences

Achieve Life Sciences, Inc. is a clinical-stage pharmaceutical company, which engages in the development and commercialization of cytisinicline for smoking cessation. Its products includes cytisine, a plant-based alkaloid with a binding affinity to the nicotinic acetylcholine receptor. The company was founded in October 1991 and is headquartered in Vancouver, Canada.

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Achieve Life Sciences reports positive Q4 results, eyes regulatory milestones

Achieve Life Sciences demonstrated strong performance in Q4 2022 with positive trial results and strategic advancements. While facing financial challenges, the company's focus on innovation and upcoming milestones positions it well for growth and regulatory success.

Achieve Life Sciences reports positive trial results, faces funding challenges

Achieve Life Sciences demonstrated promising results in vaping cessation with cytisinicline treatment, showing significant benefits and a strong market demand for cessation solutions.
While facing challenges of increasing expenses and a net loss in Q1 2023, the company's cash balance and upcoming trials provide opportunities for growth and market expansion.
The company's strategic initiatives, including the Board of Directors refresh, position Achieve Life Sciences for future success in addressing the vaping cessation market.

Achieve Life Sciences advances cytisinicline trials, targets FDA approval

Achieve Life Sciences is making significant progress with cytisinicline, despite facing financial losses. Strategic initiatives and a proactive approach to FDA engagement position the company well for future growth and NDA submission.

Achieve Life Sciences reports improved Q3 performance and eyes NDA submission

Achieve Life Sciences shows financial improvement and promising results in the cytisinicline program for smoking cessation. Engaging with the FDA for NDA submission and seeking commercial partners are key priorities. Challenges include finalizing partnerships and defining regulatory pathways, while opportunities exist in global partnerships and public health impact.

Achieve Life Sciences excels in 2023, poised for growth and innovation

Achieve Life Sciences demonstrated strong performance in achieving key milestones, securing financing, and presenting positive trial results in 2023.
While facing challenges in regulatory discussions and trial completion, the company's strategic strengths in financial stability, regulatory compliance, and innovation position it well for future growth.
Opportunities lie in market expansion, partnerships, and visibility enhancement through continued FDA engagement, commercial collaborations, and industry participation.

Achieve Life Sciences excels in trials and secures funding for growth

Achieve Life Sciences demonstrated strong operational and financial performance with positive trial outcomes and strategic financing.
Regulatory advancements and successful trial results underscore the company's credibility and potential for market expansion.
Challenges in recruitment, regulatory compliance, and financial management require attention for sustained growth and success.

Achieve Life Sciences advances vaping cessation program with FDA breakthrough

Achieve Life Sciences showcased progress in its Cytisinicline Development Program and financial stability through debt refinancing.
While facing challenges in trial enrollment and regulatory requirements, the company remains optimistic about future milestones.
The FDA breakthrough therapy designation and focus on public health underscore Achieve Life Sciences' commitment to addressing nicotine dependence.

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$60 million financing upfront with up to an additional $64.2 million tied to exercise of milestone-driven warrants

Achieve Life Sciences Announces Pricing of up to $124.2 Million Registered Direct Offering and Concurrent Private Placement

Achieve Life Sciences (NASDAQ: ACHV ) stock is dropping on Tuesday after the company provided an update on its New Drug Application (NDA) for cytisinicline. A meeting with the Food and Drug Administration (FDA) saw the agency request additional data concerning cytisinicline before it will approve its NDA.

Why Is Achieve Life Sciences (ACHV) Stock Down 44% Today?

Why Is Achieve Life Sciences (ACHV) Stock Down 25% Today?

Achieve Life Sciences Inc. shares ACHV, -1.09% dropped 25% premarket on Tuesday as analysts forecasted delays in the launch of the company's smoking cessation treatment cytisinicline. In a recent meeting with the U.S. Food and Drug Administration, the agency said it would need longer-term data beyond 12 weeks to assess potential safety risks of cytisinicline, given that the regulator views smoking cessation drugs as products for chronic, intermittent use, Achieve Life Sciences said in a regulatory filing Monday.

Achieve Life Sciences shares drop as analysts see delayed launch of smoking-cessation treatment

Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET Company Participants Nicole Jones - IR John Bencich - CEO Jerry Wan - Principal Accounting Officer Cindy Jacobs - President and CMO Conference Call Participants Thomas Flaten - Lake Street Michael Higgins - Ladenburg Thalmann John Vandermosten - Saks Operator Greetings. Welcome to Achieve Life Sciences Third Quarter Earnings Conference Call and Webcast.

Achieve Life Sciences, Inc. (ACHV) Q3 2023 Earnings Call Transcript

SEATTLE and VANCOUVER, British Columbia, Oct. 26, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced it will report its third quarter 2023 financial results and provide an update on the cytisinicline development program on Thursday, November 9, 2023 at 4:30 PM EST.

Achieve Life Sciences to Announce Third Quarter 2023 Financial Results and Host Conference Call and Webcast on November 9, 2023

SEATTLE and VANCOUVER, British Columbia, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Phase 2 ORCA-V1 trial results will be presented at the Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting, being held in London September 11–13, 2023.

Achieve Life Sciences Announces Presentation of Cytisinicline E-Cigarette Cessation (ORCA-V1) Results at Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting

Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q2 2023 Earnings Conference Call August 15, 2023 8:30 AM ET Company Participants Nicole Jones - Investor Relations John Bencich - Chief Executive Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Francois Brisebois - Oppenheimer Farhana Sakloth - Ladenburg Thalmann Laura Suriel - Alliance Resource Partners John Vandermosten - Zacks Research Operator Greetings. Welcome to the Achieve Life Sciences Second Quarter 2023 Earnings Conference Call and Webcast.

Achieve Life Sciences, Inc. (ACHV) Q2 2023 Earnings Call Transcript

Company to host conference call tomorrow, Tuesday, August 15, 2023, at 8:30 AM EDT SEATTLE and VANCOUVER, British Columbia, Aug. 14, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced second quarter 2023 financial results and provided an update on the cytisinicline development program. Recent Highlights Publication of Phase 3 ORCA-2 trial results in the Journal of the American Medical Association (JAMA) Reported statistically significant smoking cessation benefit for cytisinicline in the confirmatory Phase 3 ORCA-3 trial Announced Phase 2 ORCA-V1 trial results showing statistically significant vaping cessation benefit with cytisinicline treatment Closed equity financing with gross proceeds of approximately $16.5 million, prior to deducting placement agent commissions and estimated offering expenses Refinanced outstanding loan with Silicon Valley Bank (SVB) "We've had a very exciting and eventful first half of 2023, with two additional clinical trials reading out with positive results for cytisinicline in both smoking and vaping cessation, and the recent publication of the completed Phase 3 ORCA-2 trial in the highly prestigious Journal of the American Medical Association,” commented John Bencich, CEO of Achieve.

Achieve Life Sciences Reports Financial Results for Second Quarter 2023 and Provides Corporate Update

SEATTLE and VANCOUVER, British Columbia, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced it will report its second quarter 2023 financial results on Monday, August 14, 2023, and host a conference call and webcast on Tuesday, August 15, 2023, at 8:30 AM EDT.

Achieve Life Sciences to Announce Second Quarter 2023 Financial Results and Host Conference Call and Webcast

Cytisinicline 6- and 12-week dosing schedules, with behavioral support, demonstrated “smoking cessation efficacy and excellent tolerability”

Achieve Life Sciences Announces Publication of Cytisinicline Phase 3 ORCA-2 Smoking Cessation Trial in Journal of the American Medical Association (JAMA)

Efficacy: Phase 3 ORCA-3 trial showed significant efficacy of cytisinicline in smoking cessation, reinforcing data from ORCA-2. Safety: Cytisinicline exhibited no serious treatment-related adverse events, implying safe long-term usage.

Achieve: Exciting Smoking Cessation Drug Approval Could Come Soon

Achieve Life Sciences Inc. ACHV, +12.88% said Tuesday a second confirmatory late-stage trial of its cytisinicline for quitting smoking and nicotine dependence achieved positive results, showing a statistically significant benefit compared to placebo. The Phase 3 trial involved 792 adult smokers at 20 trial sites in the U.S. who were dosed 3 times daily with 3mg of cytisinicline for a period of six weeks or 12 weeks.

Achieve Life Sciences says confirmatory late-stage trial of its treatment for quitting smoking achieved positive results

ORCA-3 demonstrated statistically significant topline results in primary and secondary smoking cessation endpoints for both 6- and 12-week cytisinicline treatment durations compared to placebo

Achieve Life Sciences Reports Statistically Significant Smoking Cessation Benefit for Cytisinicline in Second, Confirmatory Phase 3 Clinical Trial

SEATTLE and VANCOUVER, British Columbia, May 17, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced the Company has refinanced its previous debt agreement with Silicon Valley Bank (SVB), a division of First-Citizens Bank. The Company and SVB have entered into a new contingent convertible debt agreement which refinanced the outstanding loan and accrued interest balance of $16.6 million from its previous debt agreement entered into on December 22, 2021.

Achieve Life Sciences Announces Refinancing of Outstanding Loan with Silicon Valley Bank

SEATTLE and VANCOUVER, British Columbia, May 09, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced first quarter 2023 financial results and provided an update on the cytisinicline development program. Recent Business Highlights Released positive Phase 2 ORCA-V1 clinical trial results showing statistically significant vaping cessation benefit for cytisinicline    Announced accomplishment of key milestones, including last subject dosing and last subject visit, in the Phase 3 ORCA-3 trial evaluating cytisinicline for smoking cessation   Presented additional analyses from the Phase 3 ORCA-2 trial at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting Appointed three new members to Achieve's Board of Directors “We are excited about our start to 2023, announcing statistically significant trial results from ORCA-V1 in April, and on-track to report topline results from the Phase 3 ORCA-3 trial in the second quarter,” stated John Bencich, Chief Executive Officer of Achieve.

Achieve Life Sciences Reports Financial Results for First Quarter 2023 and Provides Corporate Update

SEATTLE and VANCOUVER, British Columbia, April 26, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced it will report its first quarter 2023 financial results and provide an update on the cytisinicline development program on Tuesday, May 9, 2023 at 4:30 PM EDT.

Achieve Life Sciences to Announce First Quarter 2023 Financial Results and Host Conference Call and Webcast on May 9, 2023

Achieve: Late-Stage Biotech Developing Vaping And Smoking Cessation Drugs.

Achieve: Late-Stage Biotech Developing Vaping And Smoking Cessation Drugs

SEATTLE and VANCOUVER, British Columbia, April 14, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that John Bencich, CEO of Achieve, will present at the Life Science Innovation Northwest (LSINW) 2023 Conference being held at the Seattle Convention Center April 25-26, 2023.

Achieve Life Sciences to Present at Life Science Innovation Northwest 2023 Conference

SEATTLE, Wash. and VANCOUVER, British Columbia, March 30, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced changes to the Company's Board of Directors to continue to support the future direction of the Company. As provided in the previously reported Cooperation Agreement, as amended, between the Company and certain of its shareholders, Mr. Stuart Duty, Mr. Thomas King, and Mr. Tom Sellig have been appointed to the Board of Directors and will be nominated for election at the Company's Annual Meeting of Stockholders to be held in June 2023. Additionally, each of Mr. Donald Joseph, Dr. Martin Mattingly, and Mr. Jay Moyes will not be nominated for re-election at the Annual Meeting. “We thank Mr. Joseph, Dr. Mattingly, and Mr. Moyes for their years of service to the Company and for their invaluable strategic guidance to Achieve through the Company's growth and success,” commented Rick Stewart, Achieve's Co-Founder and Chairman of the Board of Directors. “As we look to the future, we welcome three industry veterans who bring a wealth of leadership and experience that will be imperative as we continue to work to advance cytisinicline towards FDA approval and commercialization.”

Achieve Life Sciences Announces Refresh to Board of Directors

SEATTLE, Wash. and VANCOUVER, British Columbia, March 17, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that the Company has issued an inducement grant of stock options to a new employee.    Achieve's Board of Directors approved the new employment inducement grant to purchase 25,000 shares of Achieve's common stock with the grant awarded on March 14, 2023. Achieve granted the stock options as a material inducement to the new employee for entering into an employment agreement with Achieve in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options approved under the inducement grant were issued pursuant to a stock option agreement on terms substantially similar to Achieve's 2018 Equity Incentive Plan and have a per share exercise equal to the closing price of Achieve's common stock on March 14, 2023. The stock options vest over four years, with 25% vesting on the first anniversary of the employee's start date and 1/36TH of the remaining shares vesting monthly thereafter, subject to the employee's continued employment on each such date. The stock options have a 10-year term and are subject to the terms and conditions of the stock option agreements.   About Achieve and Cytisinicline  Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2 In addition, there are over 9 million adults in the United States who use e-cigarettes, also known as vaping.3 While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease.4 In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.5 Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped.6 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, 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 addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com. Investor Relations Contact Rich Cockrell achv@cg.capital (404) 736-3838   Media Contact Glenn Silver  Glenn.Silver@Finnpartners.com (646) 871-8485  References 1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 2 U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 3Cornelius ME, Loretan CG, Wang TW, Jamal A, Homa DM. Tobacco Product Use Among Adults — United States, 2020. MMWR Morb Mortal Wkly Rep 2022;71:397–405. 4Ogunwale, Mumiye A et al. (2017) Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489]. 5Gentzke AS, Wang TW, Cornelius M, et al. Tobacco Product Use and Associated Factors Among Middle and High School Students – National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ 2022;71(no. SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1. 6Elizabeth C. Hair, Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao, Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association between e-cigarette use and future combustible cigarette use: Evidence from a prospective cohort of youth and young adults, 2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN 0306-4603. DOI: 10.1016/j.addbeh.2020.106593.

Achieve Life Sciences Announces Granting of New Hire Inducement Award

Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q4 2022 Earnings Conference Call March 16, 2023 4:30 PM ET Company Participants Nicole Jones - Investor Relations John Bencich - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Jaime Xinos - Executive Vice President, Commercial Conference Call Participants Thomas Flaten - Lake Street Capital Michael Higgins - Ladenburg Thalmann Francois Brisebois - Oppenheimer Operator Hello and welcome to the Achieve Life Sciences Fourth Quarter 2022 Earnings Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

Achieve Life Sciences, Inc. (ACHV) Q4 2022 Earnings Call Transcript

Company to host conference call March 16, 2023, at 4:30 PM EDT Company to host conference call March 16, 2023, at 4:30 PM EDT

Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2022 and Provides Corporate Update

Topline Data Expected in 2Q 2023 Topline Data Expected in 2Q 2023

Achieve Life Sciences Announces Last Subject Last Visit Completed in Phase 2 ORCA-V1 Trial of Cytisinicline for e-Cigarette Cessation

SEATTLE, Wash. and VANCOUVER, British Columbia, March 03, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, announced data from the Phase 3 ORCA-2 trial will be presented at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting, being held in San Antonio, TX, March 1-4, 2023. Additional findings from the ORCA-2 trial, that evaluated cytisinicline as a treatment for smoking cessation, will be included in the “Novel Treatments for Smoking Cessation” session held today, March 3, 2023, at 3:15 p.m. CST. The presentation will be given by ORCA-2 Principal Investigator, Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and Director, Tobacco Research and Treatment Center, Massachusetts General Hospital. Positive topline results from the ORCA-2 trial were reported in April 2022, demonstrating 6-8 times increased likelihood of smoking abstinence with 3mg cytisinicline dosed 3 times daily for a period of 6-weeks or 12-weeks compared to placebo in 810 adult U.S. smokers. The study population was approximately 52 years in age, smoked a pack of cigarettes a day, and had made 5 to 6 prior quit attempts. Additional analyses being reported today confirm that successful abstinence was observed in subgroups of smokers who received cytisinicline, regardless of age, gender, smoking history, or previous quit attempts. Subjects who received either 6 or 12-weeks of cytisinicline treatment experienced consistently higher rates of abstinence. The improvement was observed by the second week of treatment, maintained weekly throughout study treatment and during the 24- week follow-up period, compared to those who received placebo. Study compliance was high with 82% of subjects completing the 12 weeks of treatment. No treatment-related serious adverse events were reported and the majority of adverse events were mild in all subjects. Dr. Cindy Jacobs, Achieve Chief Medical Officer and President commented, “The ORCA-2 population represents a vast majority of smokers in the real world who remain heavy smokers, want to quit smoking, and have made multiple, unsuccessful quit attempts utilizing various methods. The ability of cytisinicline to improve the likelihood of quitting, regardless of prior treatments and level of nicotine dependence, will be critical for increased adoption and future prescribing, if ultimately approved by the FDA.” Achieve is currently conducting the final FDA-registration enabling Phase 3 ORCA-3 trial for smoking cessation and the Phase 2 ORCA-V1 trial evaluating cytisinicline for e-cigarette cessation. The Company continues to expect topline data results for both trials to be announced in the second quarter of 2023. For more information on cytisinicline and Achieve visit www.achievelifesciences.com . To learn more about SRNT or the SRNT Annual Meeting, please visit www.srnt.org . About Achieve and Cytisinicline  Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2 In addition, there are over 9 million adults in the United States who use e-cigarettes, also known as vaping.3 While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease.4 In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.5 Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped.6 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, 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 addiction and has not been approved by the Food and Drug Administration for any indication in the United States. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve's intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of the COVID-19 pandemic or similar public health crises and the other factors described in the risk factors set forth in Achieve's filings with the Securities and Exchange Commission from time to time, including Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. Investor Relations Contact Nicole Jones achv@cg.capital (404) 736-3838 Media Contact Glenn Silver Glenn.Silver@Finnpartners.com (646) 871-8485 References 1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 2U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 3Cornelius ME, Loretan CG, Wang TW, Jamal A, Homa DM. Tobacco Product Use Among Adults — United States, 2020. MMWR Morb Mortal Wkly Rep 2022;71:397–405. 4Ogunwale, Mumiye A et al. (2017) Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489]. 5Gentzke AS, Wang TW, Cornelius M, et al. Tobacco Product Use and Associated Factors Among Middle and High School Students – National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ 2022;71(no. SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1. 6Elizabeth C. Hair, Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao, Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association between e-cigarette use and future combustible cigarette use: Evidence from a prospective cohort of youth and young adults, 2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN 0306-4603. DOI: 10.1016/j.addbeh.2020.106593.

Achieve Life Sciences Announces Presentation of the Phase 3 ORCA-2 Trial of Cytisinicline at Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting

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