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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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

ORCA-2 phase 3 trial was a success where Cytisinicline has shown statistically significant improvement in quit rates and robust safety profile. Phase 3 ORCA-3 registration trial is ongoing, and we expect the data readout in 2Q 2023; we expect the results to be positive.

Achieve Life Sciences: All Eyes On Phase 3 Data For Smoking Cessation Drug

SEATTLE, Wash and VANCOUVER, British Columbia, Dec. 21, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,459,328 covering the mesylate salt formulation of cytisinicline and the process for its development.

Achieve Life Sciences Announces Patent Granted by USPTO for New Cytisinicline Formulation

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Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q3 2022 Earnings Conference Call November 14, 2022 4:30 PM ET Company Participants Nicole Jones - Investor Relations-CG Capital John Bencich - Chief Executive Officer Jerry Wan - Principal Accounting Officer Cindy Jacobs - President & Chief Medical Officer Conference Call Participants Thomas Flaten - Lake Street Capital François Brisebois - Oppenheimer Michael Higgins - Ladenburg Thalmann John Vandermosten - Zacks Jim Molloy - Alliance Global Partners Operator Good day, ladies and gentlemen, and welcome to Achieve Life Sciences Third Quarter 2022 Earnings Conference Call. All lines have been placed on a listen-only mode.

Achieve Life Sciences, Inc. (ACHV) Q3 2022 Earnings Call Transcript

SEATTLE, Wash and VANCOUVER, British Columbia, Oct. 31, 2022 (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 financial results and provide an update on the cytisinicline development program on Monday, November 14, 2022, at 4:30 PM EST.

Achieve Life Sciences to Announce Third Quarter Financial Results and Host Conference Call and Webcast on November 14, 2022

ORCA-3 Designed to Enable FDA Registration and Confirm the Efficacy and Safety of 3 mg Cytisinicline Three Times Daily Dosing Compared to Placebo in Adult Smokers in the United States ORCA-3 Designed to Enable FDA Registration and Confirm the Efficacy and Safety of 3 mg Cytisinicline Three Times Daily Dosing Compared to Placebo in Adult Smokers in the United States

Achieve Announces Completion of Target Enrollment in the Phase 3 ORCA-3 Trial of Cytisinicline for Smoking Cessation

Achieve Life Sciences, Inc. (NASDAQ:ACHV ) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Cindy Jacobs - President, Chief Medical Officer & Director Jerry Wan - Principal Accounting Officer John Bencich - Chief Executive Officer Conference Call Participants Michael Higgins - Ladenburg Thalmann François Brisebois - Oppenheimer John Vandermosten - Zacks Vernon Bernardino - H.C. Wainwright Jim Molloy - Alliance Global Partners Operator Good day, ladies and gentlemen, and welcome to the Achieve Life Science Second Quarter 2022 Earnings Conference Call.

Achieve Life Sciences, Inc. (ACHV) CEO John Bencich on Q2 2022 Results - Earnings Call Transcript

Company to host conference call at 4:30 PM EDT today, August 11, 2022 Company to host conference call at 4:30 PM EDT today, August 11, 2022

Achieve Reports Financial Results for Second Quarter 2022 and Provides Corporate Update

SEATTLE and VANCOUVER, British Columbia, July 28, 2022 (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 addiction, today announced it will report its second quarter financial results and provide an update on the cytisinicline development program on Thursday, August 11, 2022, at 4:30 PM EDT.

Achieve Life Sciences to Announce Second Quarter Financial Results and Host Conference Call and Webcast on August 11, 2022

SEATTLE and VANCOUVER, British Columbia, July 01, 2022 (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 addiction, today announced that the Company has issued inducement grants of stock options to two new employees.

Achieve Life Sciences Announces Granting of New Hire Inducement Awards

SEATTLE and VANCOUVER, British Columbia, June 21, 2022 (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 addiction, today announced it will be participating at the H.C. Wainwright 1st Annual Mental Health Conference. The conference is taking place in-person at the Lotte New York Palace Hotel and virtually on June 27, 2022. Details to access the presentation are as follows:

News for Achieve Life Sciences Stock (ACHV)