1. Subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months and experienced significantly fewer side effects compared to those who received varenicline

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 25, 2021 / 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 addiction, today announced online publication of the results from the Phase 3 RAUORA trial in the scientific journal Addiction. The RAUORA study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and evaluated the effectiveness and safety of cytisinicline compared to varenicline (Chantix®…

    Subjects treated with cytisinicline were 55% more likely to quit smoking at 6 months and experienced significantly fewer side effects compared to those who received varenicline

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 25, 2021 / 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 addiction, today announced online publication of the results from the Phase 3 RAUORA trial in the scientific journal Addiction. The RAUORA study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and evaluated the effectiveness and safety of cytisinicline compared to varenicline (Chantix®) as a smoking cessation aid in 679 indigenous New Zealanders (Māori) or their extended family.

    The published results indicate that cytisinicline met the pre-specified non-inferiority endpoint, and was trending towards superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79), and a 55% improvement in quit rates at six months in favor of cytisinicline when compared to varenicline. A Bayesian analysis of the primary efficacy outcome is ongoing.

    Additionally, statistically significant fewer overall adverse events (AEs) were reported in cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65, p<0.001) including a significantly lower rate of nausea when compared to subjects on varenicline. Notably, as participants were not blinded to study drug, more subjects refused to participate and withdrew consent when randomized to varenicline compared to subjects who were randomized to cytisinicline.

    "These data add to the growing body of evidence in support of cytisinicline as a much-needed, potential new treatment alternative to existing smoking cessation therapies," said John Bencich, Chief Executive Officer of Achieve Life Sciences. "Many smokers refuse to take current medications or stop treatment when they experience side effects which impedes their ability to quit successfully. We believe the tolerability profile of cytisinicline, as shown in trials such as RAUORA, may help smokers remain on treatment and lead to better outcomes for those battling nicotine addiction."

    To access the RAUORA publication, visit https://onlinelibrary.wiley.com/doi/10.1111/add.15489.

    Achieve is currently enrolling smokers in the 750-subject, Phase 3 ORCA-2 study of cytisinicline at 15 sites in the U.S. For more information on cytisinicline and the ORCA-2 study, visit www.achievelifesciences.com or www.orca-2.com.

    About the RAUORA Study

    The RAUORA study was conducted by the researchers at the University of Auckland, in conjunction with the Health Economics Research Group (HERG) at Brunel University London, and Lakes District Health Board. Currently, 3 in 10 Māori smoke, three times more than non-Māori, and supporting this population to quit smoking is a priority of the New Zealand government. The study compared cytisinicline administered on a schedule of 25 days of downward dosing titration followed by twice-daily dosing for a total of 12 weeks with varenicline administered on a schedule of 7 days of upward titration followed by twice-daily dosing for a total of 12 weeks. The primary endpoint was continuous abstinence from smoking for 6 months post-quit date.

    In total, 1,105 Māori or whānau (Māori extended family members) expressed interest in participating in the study and a total of 679 were randomized to receive either cytisinicline or varenicline. The average age of participants in the trial was 43 years and approximately 70% of the participants were women. Contact was sought over a period of six to 12 months to collect data and support their quit journey.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction, and has not been approved by the FDA for any indication in the U.S.

    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 activities, the potential market size and market acceptance for cytisinicline, the potential benefits of cytisinicline 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; 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 law.

    Media Contact
    Glenn Silver

    (646) 871-8485

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    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.

    Chantix® is a registered trademark of Pfizer Inc.

    SOURCE: Achieve Life Sciences, Inc.



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  2. Presenting Innovative Small and Mid-Cap Companies in Healthcare, Industrials, Electric Vehicles, TMT, and Consumer Products

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 16, 2021 / 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 addiction, today announced that John Bencich, Achieve's Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M-Vest and Maxim Group.

    The conference will take place on March 17 to 19 from 9:00 am-5:00 pm EDT featuring roundtable discussions, issuer presentations, fireside chats, and live Q&A with company CEOs…

    Presenting Innovative Small and Mid-Cap Companies in Healthcare, Industrials, Electric Vehicles, TMT, and Consumer Products

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 16, 2021 / 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 addiction, today announced that John Bencich, Achieve's Chief Executive Officer, has been invited to present at the Inaugural Emerging Growth Virtual Conference, presented by M-Vest and Maxim Group.

    The conference will take place on March 17 to 19 from 9:00 am-5:00 pm EDT featuring roundtable discussions, issuer presentations, fireside chats, and live Q&A with company CEOs moderated by Maxim Research Analysts. To learn more about attending, visit https://www.m-vest.com/events/2021-emerging-growth-virtual-conference.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction, and has not been approved by the FDA for any indication in the U.S.

    ABOUT M-VEST

    M Vest LLC is an online investment bank and digital community built for issuers, investors, and thought leaders to share information and access investment opportunities through capital raisings of Regulation D and Regulation A Offerings. Founded in 2017 and headquartered in New York City, M-Vest provides insights on current equity market trends, hosts presentations from public companies, and provides access to capital for emerging growth companies. M-Vest hosts live conferences and webinars featuring CEOs discussing the latest developments in their industries. M Vest LLC is a registered broker-dealer with the U.S. Securities and Exchange Commission (SEC), is a member of FINRA and SIPC, and is a sister company of Maxim Group LLC.

    ABOUT MAXIM GROUP

    Maxim Group LLC is a full-service investment banking, securities and wealth management firm headquartered in New York. The Firm provides a full array of financial services including investment banking; private wealth management; and global institutional equity, fixed-income and derivatives sales & trading, equity research and prime brokerage services. Maxim Group is a registered broker-dealer with the U.S. Securities and Exchange Commission (SEC) and the Municipal Securities Rulemaking Board (MSRB). Member of FINRA SIPC, and NASDAQ. To learn more about Maxim Group, visit maximgrp.com.

    Event Media Contact

    Beth Amorosi, AMO Communications

    917-208-7489

    Achieve Media Contact

    Glenn Silver

    (646) 871-8485

    Achieve Investor Relations Contact

    Jason Wong

    (415) 375-3340 ext. 4

    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.

    SOURCE: Achieve Life Sciences, Inc.



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  3. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 15, 2021 / 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 addiction, is pleased to announce the appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to the company's Board of Directors, effective immediately.

    "We are excited to welcome Dr. Martell and Dr. Jacobs to the board", commented Rick Stewart, Achieve's Executive Chairman of the Board of Directors. "Dr. Martell's clinical development experience compliments that of Dr. Jacobs, providing the company with depth of knowledge, particularly in the field of addiction, which is critically important…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 15, 2021 / 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 addiction, is pleased to announce the appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to the company's Board of Directors, effective immediately.

    "We are excited to welcome Dr. Martell and Dr. Jacobs to the board", commented Rick Stewart, Achieve's Executive Chairman of the Board of Directors. "Dr. Martell's clinical development experience compliments that of Dr. Jacobs, providing the company with depth of knowledge, particularly in the field of addiction, which is critically important for our continued success."

    Dr. Martell brings an impressive and diverse background of scientific, clinical, and leadership experience to the team. She is board certified in both Internal and Addiction Medicine, served over 20 years as a practicing physician at Yale, and remains active there as an Entrepreneur in Residence at the Office of Cooperative Research. She has been a pivotal leader in the development and success of numerous marketed products across multiple therapeutic categories and has held leadership and executive roles at Pfizer, Kura Oncology, and Juniper Pharmaceuticals. Dr. Martell holds a B.Sc. in Microbiology from Cornell University, an M.A. in Molecular Immunology from Boston University, and an M.D. from The Chicago Medical School.

    Dr. Jacobs currently serves as Achieve's President and Chief Medical Officer. In addition to her board appointment, she will continue in this role leading the regulatory and clinical development efforts for cytisinicline. Dr. Jacobs brings over 30 years of experience in the industry, leading multiple development programs and product regulatory approvals. She has previously held leadership and executive roles at OncoGenex, Corixa, and Immunex. Dr. Jacobs received her Bachelor's in Microbiology from Montana State University, her Master's and Ph.D. in Veterinary Pathology/Microbiology from Washington State University, and an M.D. from the University of Washington Medical School.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction, and has not been approved by the FDA for any indication in the U.S.

    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 activities, the potential market size and market acceptance for cytisinicline, the potential benefits of cytisinicline 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; 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 law.

    Media Contact

    Glenn Silver

    (646) 871-8485

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    SOURCE: Achieve Life Sciences, Inc.



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  4. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 11, 2021 / 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 addiction, today announced fourth quarter and year-end 2020 financial results and provided an update on the cytisinicline clinical development program.

    Recent Events & Highlights

    • Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States
    • Presented data on smoker and e-cigarette user attitudes and perceptions on quitting at the Society for Research on Nicotine…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 11, 2021 / 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 addiction, today announced fourth quarter and year-end 2020 financial results and provided an update on the cytisinicline clinical development program.

    Recent Events & Highlights

    • Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States
    • Presented data on smoker and e-cigarette user attitudes and perceptions on quitting at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting on February 24, 2021
    • Closed financing of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses, in December 2020
    • Facilitated Smoking Cessation Key Opinion Leader Virtual Roundtable in November 2020

    "We concluded 2020 in the best financial position since the Company's inception and with the Phase 3 ORCA-2 trial underway at 15 well-established smoking cessation research centers in the United States. As we look to the year ahead, our focus will continue to be on execution of this pivotal trial, completion of additional NDA-enabling activities, and exploration of new opportunities for expansion into additional populations, such as vaping and e-cigarette users, who may benefit from a new cessation therapeutic option like cytisinicline," commented John Bencich, Chief Executive Officer of Achieve.

    Phase 3 ORCA-2 Trial
    Achieve's first Phase 3 ORCA-2 trial was initiated in October 2020 and will randomize 750 U.S. smokers to one of three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last 4 weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. The trial is expected to complete enrollment by the middle of the 2021.

    Data Highlighting Smoker Dissatisfaction with Available Treatments Presented at SRNT
    Achieve data presented at the SRNT Annual Meeting in February 2021 provided insights into current and former smokers' perceptions on currently available cessation treatment options. In a survey of 1,122 individuals, overall satisfaction and perceived efficacy with available therapies was low, with the best performing treatment leading to satisfaction in less than one-third of the respondents. The study found a majority of prescription cessation medication users do not complete their full 3-month course of therapy, with 53% reporting less than 1 month of use. Smokers reported side effects and lack of efficacy as the most common reason for discontinuation or lack of initiation with varenicline or bupropion.

    Data Elucidating Vaping/e-Cigarette Users Behavior and Quitting Intentions Presented at SRNT
    Two Achieve posters were presented at the SRNT Annual Meeting in February 2021 reporting findings from a survey of 508 users of nicotine vape products. The results showed that the primary reason to initiate e-cigarettes/vaping was to quit combustible cigarettes. While proven successful in the cohort of subjects who only utilize vape, dual users, those who vape but also continue to smoke, reported 2-times heavier nicotine use than their counterparts. Additionally, the data indicated that 73% of e-cigarette/vape users intend to quit vaping in the next 3-12 months. Of those who intend to do so in the next 3 months, more than half reported they would be "very/extremely likely to try a new prescription product" to help them quit.

    Completed $17.3 Million Financing in December 2020
    In December 2020, Achieve announced the closing of an underwritten public offering of 2,472,500 shares of its common stock at a public offering price of $7.00, for total gross proceeds of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This included the full exercise of the underwriter's over-allotment option to purchase an additional 322,500 shares of common stock.

    Virtual Smoking Cessation KOL Roundtable on November 17, 2020
    Achieve hosted a virtual roundtable on cytisinicline and smoking cessation in November 2020. Five esteemed experts in the field of smoking cessation discussed the ongoing Phase 3 ORCA-2 trial, reviewed recent cytisinicline data, and presented evidence supporting the importance of smoking cessation in the midst of the COVID-19 pandemic.

    Financial Results
    As of December 31, 2020, the company's cash, cash equivalents, and restricted cash was $35.9 million. Total operating expenses for the fourth quarter and year ended December 31, 2020 were $4.7 million and $14.8 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2020 was $4.7 million and $14.7 million, respectively.

    As of March 11, 2021, Achieve had 6,149,917 shares outstanding.

    Conference Call Details
    Achieve will host a conference call at 4:30pm Eastern time today, Thursday, March 11, 2021. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 9395238. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    About Achieve and 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 U.S. 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 Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction, and has not been approved by the FDA for any indication in the U.S.

    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 and commercialization activities, the potential market size for cytisinicline, the potential benefits 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.

    Media Contact
    Glenn Silver

    (646) 871-8485

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    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.

    Consolidated Statements of Loss
    (In thousands, except per share and share data)
    Three months ended December 31, Twelve months ended December 31,
    2020 2019 2020 2019
    Operating expenses:
    Research and development
    2,347 1,763 6,882 9,674
    General and administrative
    2,374 1,446 7,868 6,854
    Total operating expenses
    4,721 3,209 14,750 16,528
    Loss from operations
    (4,721) (3,209) (14,750) (16,528)
    Other income (expense)
    (3) 15 20 133
    Net loss
    $ (4,724) $ (3,194) $ (14,730) $ (16,395)
    Basic and diluted net loss per share
    $ (1.11) $ (5.91) $ (5.42) $ (39.76)
    Weighted average number of basic and diluted common shares
    4,266,432 540,109 2,718,909 412,320
    Consolidated Balance Sheets
    (In thousands)
    December 31, 2020 December 31, 2019
    Assets:
    Cash, cash equivalents and restricted cash
    $35,903 $16,714
    Prepaid expenses and other current assets
    1,122 670
    Property, equipment and other assets
    229 244
    Right-of-use assets
    146 329
    License agreement
    1,864 2,087
    Goodwill
    1,034 1,034
    Total assets
    $40,298 $21,078
    Liabilities and stockholders' equity:
    Accounts payable and accrued liabilities
    $2,843 $2,666
    Current portion of long-term obligations
    92 203
    Long-term obligations
    77 159
    Stockholders' equity
    37,286 18,050
    Total liabilities and stockholders' equity
    $40,298 $21,078

    SOURCE: Achieve Life Sciences, Inc.



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  5. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 4, 2021 / 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 addiction, today announced that it will report its fourth quarter and year-end 2020 financial results and provide an update on the cytisinicline development program on Thursday, March 11, 2021 at 4:30 PM ET.

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / March 4, 2021 / 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 addiction, today announced that it will report its fourth quarter and year-end 2020 financial results and provide an update on the cytisinicline development program on Thursday, March 11, 2021 at 4:30 PM ET.

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 9395238. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    Media Contact
    Glenn Silver

    (646) 871-8485

    SOURCE: Achieve Life Sciences, Inc.



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  6. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / February 24, 2021 / 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 addiction, announced that three posters featuring data on smoker and e-cigarette user behavior will be presented today, Wednesday, February 24th at the SRNT Annual Meeting being held virtually. An overview of the data can be also accessed by visiting https://ir.achievelifesciences.com/srnt2021.

    Poster Highlights

    • "A Survey in the United States of Attitudes to Nicotine Cessation in Smokers: Smokers' Satisfaction with Available Treatments" (PH-293): Results from a recent survey of 1,122 current…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / February 24, 2021 / 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 addiction, announced that three posters featuring data on smoker and e-cigarette user behavior will be presented today, Wednesday, February 24th at the SRNT Annual Meeting being held virtually. An overview of the data can be also accessed by visiting https://ir.achievelifesciences.com/srnt2021.

    Poster Highlights

    • "A Survey in the United States of Attitudes to Nicotine Cessation in Smokers: Smokers' Satisfaction with Available Treatments" (PH-293): Results from a recent survey of 1,122 current and former smokers indicated the overall satisfaction and perceived efficacy of available cessation treatments was low. A majority of smokers who use prescription medications to quit smoking do not complete the 3-month course of therapy and concerns about side effects are reported as the key reason for non-compliance, or refusal to initiate treatment with Chantix® (varenicline) or bupropion.
    • "A Survey in the United States of Attitudes to Nicotine Cessation in Vapers: Reasons for Choosing to Vape" (PH-294) Survey results from 508 users of nicotine vape products showed that the primary reason to initiate e-cigarettes/vaping was to quit combustible cigarettes. While proven successful in the cohort of subjects who only utilize vape, dual users, those who vape but also continue to smoke, reported 2-times heavier nicotine use than their counterparts. These data suggest that dual users become more heavily addicted to nicotine due to vaping.
    • "A Survey in the United States of Attitudes to Nicotine Cessation in Vapers: Their Plans to Quit Vaping" (PH-295) Data from 508 users of nicotine vape products indicated that 73% of e-cigarette/vape users intend to quit vaping in the next 3-12 months. Of those who intend to do so in the next 3 months, more than half reported they would be "very/extremely likely to try a new prescription product" to help them quit.

    "This real-world evidence supports the critical need for a new therapeutic option for smokers and e-cigarette users who are unable to tolerate, or refuse to take, currently available treatments due to side effects or negative product perceptions," commented John Bencich, CEO of Achieve. "We know that more than 75% of Chantix users are not completing the 3-month treatment, and we believe the tolerability profile of cytisinicline, as shown in trials to date, may help smokers remain on treatment and lead to better outcomes for those battling nicotine addiction."

    Achieve is currently enrolling smokers in the 750-subject, Phase 3, ORCA-2 study of cytisinicline at 15 sites the U.S. For more information on cytisinicline and the ORCA-2 study, visit www.achievelifesciences.com or www.orca-2.com.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction, and has not been approved by the FDA for any indication in the U.S.

    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 activities, the potential market size and market acceptance for cytisinicline, the potential benefits of cytisinicline 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; 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 law.

    Media Contact

    Glenn Silver

    (646) 871-8485

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    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.

    Chantix® is a registered trademark of Pfizer Inc.

    SOURCE: Achieve Life Sciences, Inc.



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  7. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / February 11, 2021 / 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 addiction, today announced that it will present at the MicroCap Rodeo Winter Wonderland Conference, which is being held virtually on February 16th - 19th, 2021.

    Mr. John Bencich, Chief Executive Officer of Achieve Life Sciences, is scheduled to present on Tuesday, February 16th at 12:30 p.m. EST, with one-on-one meetings to be held throughout the conference.

    The presentation will be webcast live and available for replay http://ir.achievelifesciences.com/events-and-webcasts. For registration…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / February 11, 2021 / 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 addiction, today announced that it will present at the MicroCap Rodeo Winter Wonderland Conference, which is being held virtually on February 16th - 19th, 2021.

    Mr. John Bencich, Chief Executive Officer of Achieve Life Sciences, is scheduled to present on Tuesday, February 16th at 12:30 p.m. EST, with one-on-one meetings to be held throughout the conference.

    The presentation will be webcast live and available for replay http://ir.achievelifesciences.com/events-and-webcasts. For registration information and meeting requests please visit https://microcaprodeo.com/signup.

    About the MicroCap Rodeo Winter Wonderland Conference
    The MicroCap Rodeo Winter Wonderland conference is a virtual event showcasing 35 best ideas from the buy side. Qualified institutional investors recommended each of the 35 companies represented.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    Media Contact
    Glenn Silver

    (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.

    SOURCE: Achieve Life Sciences, Inc.



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  8. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / January 7, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that John Bencich, Chief Executive Officer, will present at the H.C. Wainwright BioConnect Conference being held virtually January 11-14, 2021.

    A webcast of the presentation will be available on Monday, January 11th at 6:00 AM EST and can be accessed by visiting the Achieve Investor Relations page http://ir.achievelifesciences.com/events-and-webcasts.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / January 7, 2021 / Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that John Bencich, Chief Executive Officer, will present at the H.C. Wainwright BioConnect Conference being held virtually January 11-14, 2021.

    A webcast of the presentation will be available on Monday, January 11th at 6:00 AM EST and can be accessed by visiting the Achieve Investor Relations page http://ir.achievelifesciences.com/events-and-webcasts.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    Investor Relations Contact
    Jason Wong

    (415) 375-3340 ext. 4

    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.

    SOURCE: Achieve Life Sciences, Inc.



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  9. SEATTLE and VANCOUVER, B.C., Dec. 7, 2020 /PRNewswire/ -- 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 addiction, today announced the closing of an underwritten public offering of 2,472,500 shares of its common stock at a public offering price of $7.00, for total  gross proceeds of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This includes the full exercise of the underwriter's over-allotment option to purchase an additional 322,500 shares of common stock.

    SEATTLE and VANCOUVER, B.C., Dec. 7, 2020 /PRNewswire/ -- 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 addiction, today announced the closing of an underwritten public offering of 2,472,500 shares of its common stock at a public offering price of $7.00, for total  gross proceeds of $17.3 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This includes the full exercise of the underwriter's over-allotment option to purchase an additional 322,500 shares of common stock.

    Achieve intends to use the proceeds from the offering to fund its Phase 3 ORCA-2 trial, clinical research and development, as well as for working capital and general corporate purposes. The capital from this financing extends the Company's cash runway into mid-2022.

    Lake Street Capital Markets LLC acted as the sole bookrunning manager in the offering. Maxim Group LLC served as the co-manager.

    The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-250074), which was declared effective by the Securities and Exchange Commission (SEC) on December 2, 2020.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to this offering was filed by Achieve with the SEC. Copies of the final prospectus can be obtained at the SEC's website at www.sec.gov or from Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at .

    About Achieve and 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 U.S. annually.12 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 Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    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. 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 Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and Achieve's registration statement on Form S-1 (File No. 333-250074), as amended, and Form S-1MEF (File No. 333-251088). 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 law.

    Achieve Contact

    Jason Wong



    (415) 375-3340 ext. 4

    ______________________

    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.

     

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    SOURCE Achieve Life Sciences, Inc.

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  10. SEATTLE and VANCOUVER, B.C., Dec. 3, 2020 /PRNewswire/ -- 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 addiction, today announced the pricing of an underwritten public offering of 2,150,000 shares of its common stock at a price to the public of $7.00 per share. The aggregate gross proceeds from this offering are expected to be approximately $15 million, before deducting underwriting discounts and commissions and other offering expenses payable by Achieve. Achieve has also granted the underwriters a 30-day option to purchase up to an additional 322,500 shares of common stock in connection with the…

    SEATTLE and VANCOUVER, B.C., Dec. 3, 2020 /PRNewswire/ -- 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 addiction, today announced the pricing of an underwritten public offering of 2,150,000 shares of its common stock at a price to the public of $7.00 per share. The aggregate gross proceeds from this offering are expected to be approximately $15 million, before deducting underwriting discounts and commissions and other offering expenses payable by Achieve. Achieve has also granted the underwriters a 30-day option to purchase up to an additional 322,500 shares of common stock in connection with the public offering.  All of the securities are being offered by Achieve. The offering is expected to close on or about December 7, 2020, subject to the satisfaction of customary closing conditions. 

    Lake Street Capital Markets LLC is acting as the sole bookrunning manager in the offering. Maxim Group LLC is serving as the co-manager.

    Achieve intends to use the proceeds from the offering to fund its Phase 3 ORCA-2 trial, clinical research and development, as well as for working capital and general corporate purposes.

    The securities are being offered by Achieve pursuant to a registration statement on Form S-1 (File No. 333-250074) declared effective by the Securities and Exchange Commission (SEC) on December 2, 2020, and the registration statement filed by the Company with the SEC on December 2, 2020 pursuant to Rule 462(b). The offering is being made only by means of a prospectus included in the registration statement, copies of which may be obtained from: Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at . When available, electronic copies of the final prospectus may be obtained for free by visiting the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Achieve, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

    About Achieve and 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 U.S. 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 Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    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 Achieve makes regarding the ability to complete the offering, potential exercise of the overallotment option, expected use of proceeds, potential benefits of Achieve's product candidates and platform and potential market opportunities for Achieve's product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. There can be no assurance regarding the completion of the offering. 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, and others described in Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and Achieve's registration statement on Form S-1 (File No. 333-250074). 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 law.

    Achieve Contact

    Jason Wong



    (415) 375-3340 ext. 4

    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.

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    SOURCE Achieve Life Sciences, Inc.

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  11. SEATTLE and VANCOUVER, BC, Nov. 30, 2020 /PRNewswire/ -- 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 addiction, today announced a proposed underwritten public offering in which it intends to offer and sell 1,500,000 shares of its common stock. In addition, Achieve intends to grant the underwriters a 30-day option to purchase up to an additional 225,000 shares of common stock offered in the public offering.  All of the securities are being offered by Achieve. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed…

    SEATTLE and VANCOUVER, BC, Nov. 30, 2020 /PRNewswire/ -- 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 addiction, today announced a proposed underwritten public offering in which it intends to offer and sell 1,500,000 shares of its common stock. In addition, Achieve intends to grant the underwriters a 30-day option to purchase up to an additional 225,000 shares of common stock offered in the public offering.  All of the securities are being offered by Achieve. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Lake Street Capital Markets LLC is acting as the sole bookrunning manager in the offering. Maxim Group LLC is serving as the co-manager.

    Achieve intends to use the proceeds from the offering to fund its Phase 3 ORCA-2 trial, clinical research and development, as well as for working capital and general corporate purposes.

    A registration statement on Form S-1 (File No. 333-250074) has been filed with the Securities and Exchange Commission (SEC) but has not yet become effective. Securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The offering is being made only by means of a prospectus included in the registration statement, copies of which may be obtained from: Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at . Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Achieve, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended.

    About Achieve and 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 U.S. annually.12  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  Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.  Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    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 Achieve makes regarding its intention to conduct an offering and sale of securities, the grant of the option to purchase additional shares, the ability to complete the offering and expected use of proceeds, potential benefits of Achieve's product candidates and platform and potential market opportunities for Achieve's product candidates. All statements other than statements of historical fact are statements that could be deemed forward-looking statements.  There can be no assurance regarding the completion, timing or size of the proposed offering.  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 related to market conditions, the satisfaction of customary closing conditions related to the proposed public offering, and others described in Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, and in the preliminary prospectus contained in the registration statement related to the proposed offering filed with the SEC on November 30, 2020. 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 law.

    Achieve Contact

    Jason Wong



    (415) 375-3340 ext. 4

    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.

     

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    SOURCE Achieve Life Sciences, Inc.

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  12. SEATTLE and VANCOUVER, BC, Nov. 12, 2020 /PRNewswire/ -- 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 addiction, today announced third quarter 2020 financial results and provided an update on the cytisinicline clinical development program.

    Recent Events & Highlights

    • Initiated the Phase 3 ORCA-2 clinical trial evaluating the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States
    • Promoted John Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President
    • Presented successful results from the RAUORA, head-to-head non-inferiority clinical trial comparing cytisinicline and Chantix® (varenicline), at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual Meeting
    • Presented mechanism of action data comparing 5-HT3 receptor activity of cytisinicline vs. Chantix at SRNT-E, providing rationale for differentiated side effect profile of smoking cessation treatments
    • Announced smoking cessation Key Opinion Leader Virtual Roundtable to be held on November 17, 2020

    "With the initiation of the Phase 3 ORCA-2 trial and the breakthrough evidence, both mechanistically and clinically, in support of cytisinicline in comparison to Chantix, the third quarter of 2020 has undeniably been the most pivotal in the history of our company," commented John Bencich, Chief Executive Officer of Achieve. "Our primary focus in the coming months will be enrollment and execution of ORCA-2, while continuing to explore opportunities for commercialization and expansion into new therapeutic indications, digital health technologies, and audiences who may benefit from cytisinicline, specifically, users of vapes or e-cigarettes."

    Phase 3 ORCA-2 Trial Initiation

    Achieve's first Phase 3 ORCA-2 trial was initiated in October 2020 and will randomize 750 U.S. smokers to one of three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. The primary endpoint is biochemically verified continuous abstinence during the last 4 weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo.  Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo.

    Management Team Update

    In September, the Company announced the promotion of John Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President. Mr. Bencich has been serving as Achieve's Chief Financial and Operating Officer since 2017 and will join the Board of Directors in his role. Dr. Jacobs has been serving as the Chief Medical Officer of Achieve since 2017 and will continue in her role leading the regulatory and clinical development efforts for cytisinicline. Rick Stewart will remain with Achieve as the Executive Chairman of the Board of Directors and Dr. Anthony Clark will remain in his role as Chief Scientific Officer.

    RAUORA: Significantly Fewer Adverse Events and Higher Quits Rates for Cytisinicline vs Chantix

    Final results from the New Zealand RAUORA Phase 3 non-inferiority clinical trial comparing cytisinicline to varenicline (Chantix) in Māori (indigenous New Zealanders) and whānau (family) of Māori were presented at the SRNT-E Annual Meeting in September 2020. Results showed that cytisinicline met the pre-specified non-inferiority endpoint and was trending towards superiority demonstrating a 4.29% improvement in quit rates in favor of cytisinicline. Subjects in the cytisinicline arm were approximately one and a half times more likely to have quit smoking at 6 months compared to subjects who received varenicline. Importantly, significantly fewer overall adverse events (AEs) were reported in cytisinicline-treated subjects. Of the subjects who experienced AEs (111 in the cytisinicline arm compared to 138 in the varenicline arm), there was significantly less nausea and vivid dreams.

    MOA Data Explaining Reduced Nausea and Vomiting with Cytisinicline Presented at SRNT-E

    Data presented at the SRNT-E Annual Meeting in September 2020 provides a rationale based on detailed receptor pharmacology to explain why the incidence of nausea and vomiting associated with cytisinicline appears to be consistently lower than that seen with Chantix. The preclinical study, conducted at the University of Cambridge Department of Biochemistry, was designed to examine the in vitro binding characteristics of cytisinicline compared to varenicline at the human 5-HT3 receptor. The study reported an IC50 of 0.50 mM for cytisinicline and 0.25 µM for varenicline, representing a 2000-greater fold agonist binding affinity to the 5-HT3 receptor for varenicline compared to cytisinicline.

    Virtual Smoking Cessation KOL Roundtable to be Held November 17, 2020

    Achieve announced plans to host a virtual roundtable on cytisinicline and smoking cessation on Tuesday, November 17, 2020, at 12:00PM EST. Five esteemed experts in the field of smoking cessation will discuss the ongoing ORCA-2 trial, review recent cytisinicline data, and discuss the importance of smoking cessation in the midst of the COVID-19 pandemic. Visit http://ir.achievelifesciences.com/events-and-webcasts for additional information and click here to register for the event.

    Financial Results

    As of September 30, 2020, the company's cash, cash equivalents, and restricted cash was $22.4 million. Total operating expenses for the three and nine months ended September 30, 2020 were $3.8 million and $10.0 million, respectively. Total net loss for the three and nine months ended September 30, 2020 was $3.8 million and $10.0 million, respectively.

    As of November 12, 2020, Achieve had 3,617,664 shares outstanding.

    Conference Call Details

    Achieve will host a conference call at 4:30pm Eastern time today, Thursday, November 12, 2020. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 8047128. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    About Achieve and 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 U.S. 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 Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.  

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking. 

    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 and commercialization activities, the potential market size for cytisinicline, the potential benefits 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.

    Media Contact 

    Glenn Silver 

     

    (646) 871-8485 

    Investor Relations Contact 

    Jason Wong 

      

    (415) 375-3340 ext. 4 

    References 

    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.  

    Chantix® is a registered trademark of Pfizer Inc.























    Consolidated Statements of Loss

    (In thousands, except per share and share data)

















































    Three Months Ended September 30,



    Nine Months Ended September 30,







    2020



    2019



    2020



    2019









































    Operating expenses:



















      Research and development





    1,891



    1,824



    4,535



    7,911

      General and administrative





    1,863



    1,893



    5,494



    5,408

        Total operating expenses





    3,754



    3,717



    10,029



    13,319

    Loss from operations





    (3,754)



    (3,717)



    (10,029)



    (13,319)

      Other income (expense)





    (10)



    44



    23



    118

    Net loss





    $                         (3,764)



    $                         (3,673)



    $                       (10,006)



    $                       (13,201)





















    Basic and diluted net loss per share





    $                           (1.14)



    $                           (9.07)



    $                           (4.55)



    $                         (35.96)





















    Weighted average number of basic and diluted common shares





    3,289,252



    405,012



    2,197,368



    367,103











































    Consolidated Balance Sheets

    (In thousands)



































     September 30, 



     December 31, 















    2020



    2019





















    Assets:



















      Cash, cash equivalents, short term investments and restricted cash













    $                        22,443



    $                        16,714

      Prepaid expenses and other current assets













    1,669



    670

      Property, equipment and other assets













    358



    244

      Right-of-use assets













    193



    329

      License agreement













    1,920



    2,087

      Goodwill













    1,034



    1,034

    Total assets













    $                        27,617



    $                        21,078





















    Liabilities and stockholders' equity:



















      Accounts payable and accrued liabilities













    $                          1,719



    $                          2,666

      Current portion of long-term obligations













    129



    203

      Long-term obligations













    94



    159

      Stockholders' equity













    25,675



    18,050

    Total liabilities and stockholders' equity













    $                        27,617



    $                        21,078

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-reports-financial-results-for-third-quarter-2020-and-provides-corporate-and-cytisinicline-development-update-301171373.html

    SOURCE Achieve Life Sciences, Inc.

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  13. SEATTLE and VANCOUVER, BC, Oct. 29, 2020 /PRNewswire/ -- 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 addiction, today announced that it will report its third quarter 2020 financial results and provide an update on the cytisinicline development program on Thursday, November 12, 2020 at 4:30PM ET.

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 8047128. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days. 

    Achieve Contact 

    Jason Wong 

      

    (415) 375-3340 ext. 4 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-to-announce-third-quarter-2020-financial-results-and-host-conference-call-and-webcast-on-november-12-2020-301162254.html

    SOURCE Achieve Life Sciences, Inc.

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  14. SEATTLE and VANCOUVER, BC, Oct. 27, 2020 /PRNewswire/ --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 addiction, today announced the Company will host a Key Opinion Leader (KOL) virtual roundtable event on cytisinicline and smoking cessation on Tuesday, November 17th, 2020, at 12:00PM EST

    The event will include an overview by the principal investigator of the ongoing ORCA-2 Phase 3 clinical trial of cytisinicline and provide a review of the results from the RAUORA head-to-head study of cytisinicline vs. Chantix® (varenicline). It will also feature a panel discussion, moderated by healthcare analysts Michael Higgins from Ladenburg Thalmann and Thomas Flaten from Lake Street Capital Markets, on the importance of smoking cessation in the midst of the COVID-19 pandemic, with participation from the following esteemed experts in the field of smoking cessation:

    • Nancy Rigotti, MD - Professor of Medicine, Harvard Medical School, Director of Tobacco Research & Treatment, Massachusetts General Hospital, and ORCA-2 Principal Investigator
    • Mitchell Nides, PhD - President, LA Clinical Trials LLC, ORCA-1 Principal Investigator
    • Neal Benowitz, MD - Professor of Medicine, Emeritus, University of California, San Francisco
    • Judith Prochaska, PhD, MPH - Professor of Medicine, Stanford University
    • Scott Leischow, PhD - Professor and Director, Clinical and Translational Science, Arizona State University, Former Senior Advisor for Tobacco Policy at HHS

    Additional details and registration information can be accessed with this link or by visiting the  Achieve website, http://ir.achievelifesciences.com/events-and-webcasts.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    Media Contact                                 

    Glenn Silver

     

    (646) 871-8485

    Investor Relations Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    Chantix® is a registered trademark of Pfizer Inc.  

    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.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-to-host-smoking-cessation-key-opinion-leader-virtual-roundtable-on-november-17th-2020-301160210.html

    SOURCE Achieve Life Sciences, Inc.

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  15. SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / October 8, 2020 / 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 addiction, today announced that it has been invited to present at the MicroCap Rodeo Best Ideas Bowl, which is being held virtually October 13th - 16th, 2020.

    Mr. John Bencich, Chief Executive Officer of Achieve Life Science's, is scheduled to present on Tuesday, October 13th at 3:30 p.m. ET, with one-on-one meetings to be held throughout the conference. The presentation will be webcast live and available for replay - http://ir.achievelifesciences.com/events-and-webcasts.

    To receive additional…

    SEATTLE, WA and VANCOUVER, BC / ACCESSWIRE / October 8, 2020 / 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 addiction, today announced that it has been invited to present at the MicroCap Rodeo Best Ideas Bowl, which is being held virtually October 13th - 16th, 2020.

    Mr. John Bencich, Chief Executive Officer of Achieve Life Science's, is scheduled to present on Tuesday, October 13th at 3:30 p.m. ET, with one-on-one meetings to be held throughout the conference. The presentation will be webcast live and available for replay - http://ir.achievelifesciences.com/events-and-webcasts.

    To receive additional information, request an invitation, or to schedule a one-on-one meeting, please contact .

    About the MicroCap Rodeo Best Ideas Bowl

    The MicroCap Rodeo is back with its first ever "Best Ideas Bowl." This conference is a virtual conference that brings you the top 25 best ideas from the buy side. Qualified institutional investors recommended each of the 25 companies represented as one of their best ideas. Those of you who attended the 2019 MicroCap Rodeo in Austin, Texas, know that we're focused on alpha. The Best Ideas Bowl is sure to have some big winners too.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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.

    Media Contact

    Glenn Silver

    (646) 871-8485

    Investor Relations Contact

    Jason Wong

    (415) 375-3340 ext. 4

    SOURCE: Achieve Life Sciences, Inc.



    View source version on accesswire.com:
    https://www.accesswire.com/609373/Achieve-Life-Sciences-Announces-to-Present-at-the-MicroCap-Best-Ideas-Conference-October-13-2020

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  16. SEATTLE and VANCOUVER, B.C., Oct. 7, 2020 /PRNewswire/ -- 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 addiction, today announced initiation of the Phase 3 ORCA-2 clinical trial. ORCA-2 will evaluate the efficacy and safety of 3 mg cytisinicline dosed 3 times daily compared to placebo in 750 adult smokers at 15 clinical sites in the United States.

    "We are very excited to be participating in this important trial that will hopefully lead to a widely available new treatment option for smokers in the U.S. and around the globe," commented Nancy Rigotti, MD, Massachusetts General Hospital, Professor of Medicine at Harvard Medical School, and Primary Investigator of the ORCA-2 trial. "Smoking remains the number one cause of preventable death and we clearly need new options to help people who smoke avoid the enormous toll of illness and death attributable to cigarette smoking."

    ORCA-2 participants will be randomized to one of three study arms to determine the smoking cessation efficacy and safety profile of cytisinicline administered for either 6 or 12 weeks, compared to placebo. All subjects will receive standard behavioral support and will be assigned to one of the following groups:

    • Arm A: 12 weeks of placebo
    • Arm B: 6 weeks of cytisinicline, followed by 6 weeks of placebo
    • Arm C: 12 weeks of cytisinicline

    The primary outcome measure of success in the ORCA-2 trial is biochemically verified continuous abstinence during the last four weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo.  Each treatment arm will be compared independently to the placebo arm, and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. Secondary outcome measures will be conducted to assess continued abstinence rates through 6 months from the start of study treatment.

    "We are optimistic that the ORCA-2 trial will add to the growing body of evidence demonstrating that cytisinicline, if approved, can be an effective and well-tolerated treatment for smokers who want to quit," stated John Bencich, Chief Executive Officer of Achieve. "Importantly, based on the findings of ORCA-1 and modifications to the cytisinicline treatment regimen, including a longer duration of treatment and a higher dose, we believe ORCA-2 results may yield an improvement in quit rates compared to previously reported data."

    For additional information on cytisinicline and the ORCA-2 trial, visit achievelifesciences.com or orcaprogram.com.

    About Achieve and 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 U.S. 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

    Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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, the timing and nature of cytisinicline clinical development activities, the potential market size for cytisinicline and the effectiveness and potential uses and benefits of cytisinicline. 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 cytisinicline may not be effective in treating a larger breadth of diseases and addictions; 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; impacts from the COVID-19 pandemic; 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.

    Media Contact                                 

    Glenn Silver

     

    (646) 871-8485

    Investor Relations Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    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.

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    SOURCE Achieve Life Sciences, Inc.

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  17. SEATTLE and VANCOUVER, BC, Sept. 30, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced the promotion of John Bencich to Chief Executive Officer. Mr. Bencich has been serving as Achieve's Chief Financial and Operating Officer since 2017. Mr. Bencich will join the Board of Directors in his role as Chief Executive Officer. Rick Stewart, Achieve's current Chairman and Chief Executive Officer, will remain with Achieve as the Executive Chairman of the Board of Directors.

    Additionally, Dr. Cindy Jacobs will be promoted to the role of President. Dr. Jacobs has been serving as the Chief Medical Officer of Achieve since 2017 and will continue in this role leading the regulatory and clinical development efforts for cytisinicline. Dr. Anthony Clark will step down from the Board of Directors but will remain in his role as Chief Scientific Officer. Mr. Jerry Wan, currently Achieve's Sr. Director of Accounting Operations, will assume the role of Principal Accounting Officer.

    "John, Cindy, and Jerry have demonstrated exemplary leadership driving the clinical development, regulatory, and financial objectives of Achieve in its pursuit of cytisinicline as an aid to smoking cessation," stated Rick Stewart, Executive Chairman of Achieve. "Given our focus on regulatory approval and commercialization in the U.S. plus international travel restrictions due to the COVID-19 pandemic, we feel this is the appropriate time to recognize their contributions and transition to our new management structure."

    The Company had approximately $26.7 million of cash available on a pro forma basis when including cash on hand at June 30, 2020 and proceeds from equity financings and warrant exercises in the third quarter. The company plans to initiate the Phase 3 ORCA-2 trial in the fourth quarter of 2020.

    About Achieve and Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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, the timing and nature of cytisinicline clinical development activities, the potential market size for cytisinicline, the potential benefits 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.

    Media Contact                                 

    Glenn Silver



    (646) 871-8485

    Investor Relations Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    1  World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

     

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    SOURCE Achieve Life Sciences, Inc.

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  18. SEATTLE and VANCOUVER, BC, Sept. 18, 2020 /PRNewswire/ -- 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 addiction, today announced presentation of final results from the RAUORA trial, led by Dr. Natalie Walker, Associate Professor at the University of Auckland. RAUORA evaluated the effectiveness and safety of cytisinicline compared to varenicline as a smoking cessation aid in 679 indigenous New Zealanders (Māori) or their extended family, (337 in the cytisinicline arm, 342 in the varenicline arm). Results were presented today at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual…

    SEATTLE and VANCOUVER, BC, Sept. 18, 2020 /PRNewswire/ -- 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 addiction, today announced presentation of final results from the RAUORA trial, led by Dr. Natalie Walker, Associate Professor at the University of Auckland. RAUORA evaluated the effectiveness and safety of cytisinicline compared to varenicline as a smoking cessation aid in 679 indigenous New Zealanders (Māori) or their extended family, (337 in the cytisinicline arm, 342 in the varenicline arm). Results were presented today at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual Meeting.

    The primary endpoint of the non-inferiority trial was to demonstrate that cytisinicline quit rates would be no less than 10% lower than the quit rates for varenicline. Results showed that cytisinicline met the pre-specified non-inferiority endpoint and was trending towards superiority with an Absolute Risk Difference of +4.29 in favor of cytisinicline (95% CI -0.22 to 8.79), demonstrating a 4.29% improvement in quit rates in favor of cytisinicline. Specifically, continuous abstinence rates at 6 months, verified by exhaled carbon monoxide, were 12.1% for cytisinicline compared to 7.9% for varenicline. The Relative Risk was 1.55 on an intent-to-treat basis, indicating that subjects in the cytisinicline arm were approximately one and a half times more likely to have quit smoking at 6 months compared to subjects who received varenicline.

    Additionally, significantly fewer overall adverse events (AEs) were reported in cytisinicline-treated subjects (Relative Risk 0.56, 95% CI 0.49 to 0.65, p<0.001). Notably, of the subjects who experienced adverse events (111 in the cytisinicline arm compared to 138 in the varenicline arm), there was significantly less nausea (22.5% vs. 39.1%) and vivid dreams (7.2% vs. 17.4%) respectively.

    "In this trial, subjects who received cytisinicline were on average 55% more likely to quit smoking and about half as likely to experience adverse events," said Cindy Jacobs, Chief Medical Officer of Achieve. "Adverse events can often lead to poor compliance, discontinuation of treatment, and worse quit rates. The safety profile in RAUORA confirms what we have seen historically, that cytisinicline continues to demonstrate lower AEs, in particular, reduced nausea, which is the most commonly reported AE for varenicline."

    "It has been over a decade since the launch of Chantix and there still remain over 34 million smokers in the U.S. alone. New, effective treatments, such as cytisinicline, that offer improved tolerability are desperately needed to help the millions of people who are addicted to nicotine," commented Richard Stewart, Chairman and Chief Executive Officer of Achieve. "Importantly, the benefits observed in the RAUORA study were achieved using a lower dose of cytisinicline in a difficult-to-treat patient population. We expect to demonstrate even more impressive efficacy in the upcoming Phase 3 ORCA-2 trial, that will utilize our 3 mg dose and optimized dosing schedule."

    For additional information please visit http://ir.achievelifesciences.com/events-and-webcasts.

    About RAUORA

    The RAUORA study was conducted by the researchers at the University of Auckland, in conjunction with the Health Economics Research Group (HERG) at Brunel University London, and Lakes District Health Board. Currently, 3 in 10 Māori smoke, three times more than non-Māori, and supporting this population to quit smoking is a priority of the New Zealand government. The study compared 1.5mg cytisinicline administered on a schedule of 25 days of downward dosing titration followed by twice-daily dosing for a total of 12 weeks with varenicline administered on a schedule of 7 days of upward titration followed by twice-daily dosing for a total of 12 weeks. The primary endpoint was continuous abstinence from smoking for 6 months post-quit date.

    The trial demonstrated that cytisinicline plus behavioral support was at least as effective as varenicline plus behavioral support at six months. In addition, the trial showed that cytisinicline resulted in significantly fewer reported adverse events when compared to varenicline.

    In total, 1,105 Māori or whānau (Māori extended family members) expressed interest in participating in the study and a total of 679 were randomized to receive either cytisinicline or varenicline. The average age of participants in the trial was 43 years and approximately 70% of the participants were women. Contact was sought over a period of six to 12 months to collect data and support their quit journey.

    About Achieve and Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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, the timing, and nature of cytisinicline clinical development activities, the potential market size for cytisinicline and the potential benefits of cytisinicline. 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; impacts from the COVID-19 pandemic; 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.

    Media Contact                                 

    Glenn Silver



    (646) 871-8485

    Investor Relations Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    Chantix® is a registered trademark of Pfizer Inc.  

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-announces-presentation-of-investigator-led-rauora-trial-data-demonstrating-significantly-fewer-side-effects-with-higher-quit-rates-for-cytisinicline-cytisine-compared-to-chantix-varenicline-in-first-head-to-head-compa-301133947.html

    SOURCE Achieve Life Sciences, Inc.

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  19. SEATTLE, and VANCOUVER, British Columbia, Sept. 18, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced data presented at the Society for Research on Nicotine and Tobacco European (SRNT-E) Annual Meeting.

    The presentation, "Cytisine's Lower Potency at 5-HT3 Receptors May Explain its Lower Incidence of Nausea and Vomiting than Varenicline", provides a rationale based on detailed receptor pharmacology to explain why the incidence of nausea and vomiting associated with cytisinicline appears to be consistently lower than that seen with varenicline.

    The study, conducted at the University of Cambridge Department of Biochemistry by Professor Sarah Lummis and Dr. Kerry Price, was designed to examine the in vitro binding characteristics of cytisinicline compared to varenicline at the human 5-HT3 receptor. Using a radioligand antagonist displacement design, the study reported an IC50 of 0.50 mM for cytisinicline and 0.25 µM for varenicline, representing a 2000-greater fold agonist binding affinity to the 5-HT3 receptor for varenicline compared to cytisinicline.

    "It is well-established that agonist activation of 5-HT3 receptors in the brain stem directly leads to nausea and vomiting. These data provide further rationale to explain what has been consistently observed in clinical studies reporting the adverse event profiles of cytisinicline and varenicline," commented Achieve's Chief Scientific Officer, Dr. Anthony Clarke. "Nausea and vomiting can greatly impact smoker's compliance with medication, their willingness to complete the course of treatment, and ultimately, their ability to successfully quit smoking."

    Additional safety and efficacy data from the RAUORA head-to-head non-inferiority trial of cytisinicline vs. varenicline will be presented later today by Dr. Natalie Walker at 4:15PM CET. For additional information please visit http://ir.achievelifesciences.com/events-and-webcasts.

    About Achieve and Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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, the timing and nature of cytisinicline clinical development activities, the potential market size for cytisinicline and the effectiveness and potential uses and benefits of cytisinicline. 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 cytisinicline may not be effective in treating a larger breadth of diseases and addictions; 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; impacts from the COVID-19 pandemic; 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.

    Media Contact  

    Glenn Silver

     

    (646) 871-8485

    Investor Relations Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    Chantix® is a registered trademark of Pfizer Inc.

    World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-announces-results-from-evaluation-of-cytisinicline-cytisine-versus-chantix-varenicline-in-5-ht3-receptor-binding-assay-study-301133675.html

    SOURCE Achieve Life Sciences, Inc.

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  20. SEATTLE and VANCOUVER, BC, Sept. 10, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that cytisinicline data will be featured in two presentations on Friday, September 18th, at the SRNT-E virtual conference.  Both presentations evaluate positive findings from studies comparing cytisinicline to varenicline (Chantix®).

    • "Cytisine's Lower Potency at 5-HT3 Receptors May Explain its Lower Incidence of Nausea and Vomiting than Varenicline", presented by Achieve's Chief Scientific Officer, Dr. Anthony Clarke, at 1:00PM CET.
    • "Is Cytisine At Least as Effective as Varenicline for Smoking Cessation? Findings from a Non-Inferiority Trial in Indigenous New Zealanders and their Extended Family", presented by the RAUORA study Primary Investigator, Dr. Natalie Walker, at 4:15PM CET.

    The presentations will be followed by a 30-minute live Q&A session with the authors and additional details can be found at http://ir.achievelifesciences.com/events-and-webcasts.

    About Achieve and Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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, the timing and nature of cytisinicline clinical development activities, the potential market size for cytisinicline and the effectiveness and potential uses and benefits of cytisinicline. 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 cytisinicline may not be effective in treating a larger breadth of diseases and addictions; 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; impacts from the COVID-19 pandemic; 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.

    Media Contact                                 

    Glenn Silver

     

    (646) 871-8485

    Investor Relations Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    Chantix® is a registered trademark of Pfizer Inc.

                                                                                                  

    1
      World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

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    SOURCE Achieve Life Sciences, Inc.

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  21. SEATTLE and VANCOUVER, BC, Sept. 3, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that it will present at two upcoming investor conferences.

    • H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16th
      • John Bencich, Chief Financial and Operating Officer, will present a virtual corporate overview at the H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday, September 16th at 3:30 PM ET. A live webcast of the presentation can be accessed by visiting http://ir.achievelifesciences.com/events-and-webcasts. A replay of the presentation will be archived on Achieve's website following the conference.



    • Lake Street Capital Markets 4th Annual Best Ideas Growth (BIG4) Conference on Thursday, September 17th
      • Management will be hosting one-on-one meetings with investors at the Lake Street Capital Markets 2020 Best Ideas Growth (BIG4) Conference, to be held virtually on Thursday, September 17th, 2020. This conference is an invitation-only event, featuring over 50 dynamic, small-cap companies interacting with top institutional investors. For those interested in arranging a one-on-one meeting with Achieve management, please contact your Lake Street Capital Markets representative.

    About Achieve and Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide.1 It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking.2 Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    Investor Relations Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-to-present-at-upcoming-investor-conferences-301123636.html

    SOURCE Achieve Life Sciences, Inc.

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  22. SEATTLE and VANCOUVER, British Columbia, Aug. 6, 2020 /PRNewswire/ -- 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 addiction, today announced second quarter 2020 financial results and provided an update on the cytisinicline clinical development program.

    Recent Highlights

    • Announced successful topline results from the investigator initiated RAUORA head-to-head non-inferiority clinical trial comparing cytisinicline and Chantix® (varenicline) as a treatment to quit smoking
    • Closed a Registered Direct Offering for gross proceeds of approximately $6 million, prior to deducting placement agent commissions and estimated offering expenses
    • Entered into an Underwritten Public Offering for estimated gross proceeds of $7.5 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This financing is expected to close on or about August 6, 2020, subject to the satisfaction of customary closing conditions
    • New patent granted in the U.S. for novel analogs of cytisinicline for use in CNS and addiction indications

    "It has been a busy and exciting quarter with new evidence further reinforcing our belief that cytisinicline has the potential to provide a more tolerable cessation treatment to millions of smokers who want to quit," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. We continue to focus our efforts on initiation of the 750 patient Phase 3 ORCA-2 trial in the second-half of 2020, subject to the ability to conduct the trial safely in light of the COVID-19 pandemic."

    Successful RAUORA Head-to-Head vs Chantix® Study Results

    Achieve announced the successful topline results from the New Zealand RAUORA Phase 3 non-inferiority clinical trial comparing cytisinicline to varenicline (Chantix) in Māori (indigenous New Zealanders) and whānau (family) of Māori. The trial achieved statistical significance in showing that cytisinicline plus behavioral support was at least as effective as varenicline plus behavioral support at six months. In addition, the trial showed that cytisinicline resulted in significantly fewer reported adverse events when compared to varenicline. The study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and was funded by the Health Research Council of New Zealand.  The final RAUORA trial results have been submitted for presentation at The Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting in September 2020.

    Closed Registered Direct Offering for Gross Proceeds of $6 million

    Achieve entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of 731,707 shares of common stock at a price of $8.20 per share in a registered direct offering, resulting in total gross proceeds of approximately $6 million, prior to deducting placement agent fees and estimated offering expenses. The financing was closed in early July 2020.

    Entered into an Underwritten Public Offering for Gross Proceeds of $7.5 million

    On August 3, 2020, Achieve entered into an Underwritten Public Offering to which it will sell 569,043 shares of common stock, including 92,856 shares subject to the underwriters' option to purchase additional shares, at a price of $10.50 per share, and 142,857 pre-funded warrants at a price of $10.499 per pre-funded warrant, which represents the per share public offering price for the shares of common stock less $0.001 per shares exercise price for each pre-funded warrant. Total gross proceeds from the offering are expected to be approximately $7.5 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This financing is expected to close on or about August 6, 2020, subject to the satisfaction of customary closing conditions.

    Patent Granted in the U.S. for Novel Analogs of Cytisinicline

    Achieve announced that the United States Patent and Trademark Office has granted Achieve a patent on derivatives of cytisinicline and use thereof. The newly patented analogs provide the opportunity for selective targeting of nAChRs in the brain in order to treat a number of conditions, such as Alzheimer's disease, depression, anxiety, schizophrenia, epilepsy, Parkinson's disease and addiction.

    Financial Results

    As of June 30, 2020, the company's cash, cash equivalents, and restricted cash was $12.2 million, exclusive of the funds from the July and August financings totaling $13.5 million gross proceeds.  Total operating expenses for the three and six months ended June 30, 2020 were $2.9 million and $6.3 million, respectively. Total net loss for the three and six months ended June 30, 2020 was $2.9 million and $6.2 million, respectively.

    As of August 6, 2020, Achieve had 3,587,205 shares outstanding.

    Conference Call Details

    Achieve will host a conference call at 4:30pm Eastern time today, Thursday, August 6, 2020. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 1661409. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    About Achieve and Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide[1]. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking[2]. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.



    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 ability to secure any non-dilutive financing, the timing and nature of cytisinicline clinical development activities,  the potential market size for cytisinicline, the potential benefits 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.

    Achieve Contact

    Jason Wong



    (415) 375-3340 ext. 4

    Chantix® is a registered trademark of Pfizer Inc.

     

    Consolidated Statements of Loss

    (In thousands, except per share and share data)

















































    Three months ended June 30,



    Six months ended June 30,







    2020



    2019



    2020



    2019









































    Operating expenses:



















      Research and development





    1,103



    2,032



    2,644



    6,087

      General and administrative





    1,815



    1,630



    3,631



    3,515

        Total operating expenses





    2,918



    3,662



    6,275



    9,602

    Loss from operations





    (2,918)



    (3,662)



    (6,275)



    (9,602)

      Other income (expense)





    (4)



    38



    33



    74

    Net loss





    $                             (2,922)



    $                             (3,624)



    $                             (6,242)



    $                             (9,528)





















    Basic and diluted net loss per share





    $                                (1.68)



    $                             (10.08)



    $                                (3.79)



    $                             (27.39)





















    Weighted average number of basic and diluted common shares





    1,744,014



    359,484



    1,645,426



    347,836









































    Consolidated Balance Sheets

    (In thousands)



































     June 30, 



     December 31, 















    2020



    2019





















    Assets:



















      Cash, cash equivalents, short term investments and restricted cash













    $                            12,161



    $                            16,714

      Prepaid expenses and other current assets













    545



    670

      Property, equipment and other assets













    502



    244

      Right-of-use assets













    240



    329

      License agreement













    1,976



    2,087

      Goodwill













    1,034



    1,034

    Total assets













    $                            16,458



    $                            21,078





















    Liabilities and stockholders' equity:



















      Accounts payable and accrued liabilities













    $                               1,645



    $                               2,666

      Current portion of long-term obligations













    165



    203

      Long-term obligations













    110



    159

      Stockholders' equity













    14,538



    18,050

    Total liabilities and stockholders' equity













    $                            16,458



    $                            21,078

    [1]World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    [2]Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-reports-financial-results-for-second-quarter-2020-and-provides-update-on-cytisinicline-development-program-301108047.html

    SOURCE Achieve Life Sciences, Inc.

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  23. SEATTLE and VANCOUVER, BC, Aug. 4, 2020 /PRNewswire/ -- 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 addiction, today announced the pricing of an underwritten public offering of 476,187 shares of its common stock at a price to the public of $10.50 per share. In addition, Achieve is offering to certain investors whose purchase of common stock would result in the investor, together with its affiliates, beneficially owning more than 9.99% of Achieve's common stock following the completion of the offering, pre-funded warrants to purchase up to an aggregate of 142,857 shares of common stock at a purchase…

    SEATTLE and VANCOUVER, BC, Aug. 4, 2020 /PRNewswire/ -- 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 addiction, today announced the pricing of an underwritten public offering of 476,187 shares of its common stock at a price to the public of $10.50 per share. In addition, Achieve is offering to certain investors whose purchase of common stock would result in the investor, together with its affiliates, beneficially owning more than 9.99% of Achieve's common stock following the completion of the offering, pre-funded warrants to purchase up to an aggregate of 142,857 shares of common stock at a purchase price of $10.499 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.001 per share exercise price for each such pre-funded warrant. The aggregate gross proceeds from this offering are expected to be approximately $6.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by Achieve. Achieve has also granted the underwriters a 30-day option to purchase up to an additional 92,856 shares of common stock in connection with the public offering. All of the securities are being offered by Achieve. The offering is expected to close on or about August 6, 2020, subject to the satisfaction of customary closing conditions.

    Lake Street Capital Markets LLC is acting as the sole book-running manager in the offering.

    Achieve intends to use the proceeds from the offering to fund clinical research and development, and for general working capital.

    The securities are being offered by Achieve pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, and when available, the final prospectus supplement, may be obtained from:  Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at . Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Achieve, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Achieve & Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 the Company makes regarding its expectation of market conditions and the satisfaction of customary closing conditions related to the offering, its ability to complete the offering and expected use of proceeds and anticipated preclinical and clinical development activities, timing of announcements of clinical results, potential benefits of the Company's product candidates and platform and potential market opportunities for the Company's product candidates. 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 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 law.

    Achieve Contact

    Jason Wong



    (415) 375-3340 ext. 4

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

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  24. SEATTLE and VANCOUVER, BC, Aug. 3, 2020 /PRNewswire/ -- 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 addiction, today announced a proposed underwritten public offering in which it intends to offer and sell shares of its common stock and, to certain investors whose purchase of common stock would result in the investor, together with its affiliates, beneficially owning more than 9.99% of Achieve's common stock following the completion of the offering, pre-funded warrants to purchase shares of common stock. In addition, Achieve intends to grant the underwriters a 30-day option to purchase up to an additional…

    SEATTLE and VANCOUVER, BC, Aug. 3, 2020 /PRNewswire/ -- 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 addiction, today announced a proposed underwritten public offering in which it intends to offer and sell shares of its common stock and, to certain investors whose purchase of common stock would result in the investor, together with its affiliates, beneficially owning more than 9.99% of Achieve's common stock following the completion of the offering, pre-funded warrants to purchase shares of common stock. In addition, Achieve intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the securities are being offered by Achieve. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Lake Street Capital Markets LLC is acting as the sole book-running manager in the offering.

    Achieve intends to use the proceeds from the offering to fund clinical research and development, and for general working capital.

    The securities are being offered by Achieve pursuant to a registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at . Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at http://www.sec.gov.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Achieve, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Achieve & Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 Achieve makes regarding its intention to conduct an offering and sale of securities, the grant of the option to purchase additional shares, the ability to complete the offering and expected use of proceeds and anticipated preclinical and clinical development activities, timing of announcements of clinical results, potential benefits of Achieve's product candidates and platform and potential market opportunities for Achieve's product candidates. 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 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 law.

    Achieve Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

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  25. SEATTLE and VANCOUVER, British Columbia, July 31, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that the United States Patent and Trademark Office has granted Achieve a patent (US 2020/0172544 A1) on novel analogs of cytisinicline, a process for their preparation, and their use in the prevention or treatment of CNS and addictive disorders.

    Cytisinicline is a selective partial agonist of nicotinic acetylcholine receptors (nAChRs), which underlies its activity in nicotine addiction. nACHRs are more broadly involved in a range of physiological functions, such as cognitive function, learning and memory, emotion and control of movement. The newly patented analogs provide the opportunity for selective targeting of nAChRs in the brain in order to treat a number of conditions, such as Alzheimer's disease, depression, anxiety, schizophrenia, epilepsy, Parkinson's disease and addiction.

    "While smoking cessation and nicotine addiction continue to be our primary focus, it is critically important that we continue to expand our intellectual property portfolio through patent extensions and future potential indications of cytisinicline," stated Rick Stewart, Chairman and Chief Executive Officer of Achieve. 

    About Achieve and Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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, the timing and nature of cytisinicline clinical development activities, the potential market size for cytisinicline and the effectiveness and potential uses and benefits of cytisinicline. 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 cytisinicline may not be effective in treating a larger breadth of diseases and addictions; 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; impacts from the COVID-19 pandemic; 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.

    Media Contact                                 

    Glenn Silver

    Email:

    Telephone: 1 646 871 8485

    1  World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

     

     

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    SOURCE Achieve Life Sciences, Inc.

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  26. SEATTLE and VANCOUVER, British Columbia, July 28, 2020 /PRNewswire/ -- 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 addiction, today announced that it will report its second quarter 2020 financial results on Thursday, August 6, 2020. Company management will host a conference call and live webcast at 4:30 pm Eastern Time to report financial results and provide an update on the cytisinicline clinical development program.

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 1661409. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days. 

    Achieve Contact 

    Jason Wong 

      

    (415) 375-3340 ext. 4 

     

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    SOURCE Achieve Life Sciences, Inc.

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  27. SEATTLE and VANCOUVER, BC, June 29, 2020 /PRNewswire/ -- 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 addiction, today announced that it has entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of 14,634,146 shares of common stock at a price of $0.41 per share in a registered direct offering, resulting in total gross proceeds of approximately $6 million, prior to deducting placement agent fees and estimated offering expenses. The offering is expected to close on or about July 1, 2020, subject to customary closing conditions.

    SEATTLE and VANCOUVER, BC, June 29, 2020 /PRNewswire/ -- 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 addiction, today announced that it has entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of 14,634,146 shares of common stock at a price of $0.41 per share in a registered direct offering, resulting in total gross proceeds of approximately $6 million, prior to deducting placement agent fees and estimated offering expenses. The offering is expected to close on or about July 1, 2020, subject to customary closing conditions.

    Lake Street Capital Markets LLC is acting as exclusive placement agent for the registered direct offering.

    The shares of common stock were offered pursuant to a shelf registration statement on Form S-3 (File No. 333-229019), which was declared effective by the United States Securities and Exchange Commission ("SEC") on February 11, 2019. The Company intends to use the proceeds from the offering to fund clinical research and development, and for general working capital.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock will be filed by the Company with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from Lake Street Capital Markets LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at .

    About Achieve & Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 completion of the offering and the expected net proceeds of the offering. 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 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 law.

    Achieve Contact

    Jason Wong

     

    (415) 375-3340 ext. 4

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

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    SOURCE Achieve Life Sciences, Inc.

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  28. Cytisinicline demonstrated quit rates at least as effective as varenicline

    Participants on cytisinicline experienced significantly fewer side effects than those on varenicline

    SEATTLE and VANCOUVER, BC, June 29, 2020 /PRNewswire/ -- 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 addiction, today announced the successful topline results from the New Zealand RAUORA Phase 3 non-inferiority clinical trial comparing cytisinicline to varenicline (Chantix®) in Māori (indigenous New Zealanders) and whānau (family) of Māori. The study was led by Dr. Natalie Walker, Associate Professor at the University of…

    Cytisinicline demonstrated quit rates at least as effective as varenicline

    Participants on cytisinicline experienced significantly fewer side effects than those on varenicline

    SEATTLE and VANCOUVER, BC, June 29, 2020 /PRNewswire/ -- 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 addiction, today announced the successful topline results from the New Zealand RAUORA Phase 3 non-inferiority clinical trial comparing cytisinicline to varenicline (Chantix®) in Māori (indigenous New Zealanders) and whānau (family) of Māori. The study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and was funded by the Health Research Council of New Zealand.

    The RAUORA trial was designed to evaluate the effectiveness, safety, and cost-effectiveness of cytisinicline compared to varenicline as a smoking cessation aid. In total, the study randomized 679 subjects to receive 12 weeks of either cytisinicline or varenicline. The primary endpoint was a comparison of biochemically confirmed continuous abstinence rates at 6 months, and the trial was designed to assess if the two agents were non-inferior to each other. The trial achieved statistical significance in showing that cytisinicline plus behavioral support was at least as effective as varenicline plus behavioral support at six months. In addition, the trial showed that cytisinicline resulted in significantly fewer reported adverse events when compared to varenicline. The final RAUORA trial results have been submitted for presentation at The Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting in September 2020.

    "The positive topline results of the RAUORA Phase 3 trial, which is the first, direct head-to-head comparative study between cytisinicline and varenicline, provide additional evidence that cytisinicline is at least as effective as varenicline while offering improved tolerability," said Rick Stewart, Chairman and Chief Executive Officer of Achieve. "Importantly, these benefits were achieved using a lower dose of cytisinicline. Future cytisinicline clinical trials, sponsored by Achieve, will use a higher dose and optimized dosing schedule, and we believe that this change will allow us to demonstrate even better efficacy than what was seen in the RAUORA trial."

    "In an effort to achieve New Zealand's Smokefree 2025 goal, smoking rates need to decrease substantially, particularly for Māori and their family, who have the highest prevalence of smoking and the slowest decline in prevalence over the last 20 years," said Dr. Natalie Walker, Associate Professor at the University of Auckland and Principal investigator for the RAUORA trial. "We found that cytisinicline was just as good as Chantix in helping people to quit smoking and stay quit. In addition, we found that fewer people in the cytisinicline group reported any side effects from the medicine compared to those in the Chantix group. These results demonstrated that the study was successful." 

    "We look forward to seeing the publication of full results from this important study which will add to the growing body of clinical evidence supporting cystisinicline's potential as a new tool in the fight against smoking and nicotine addiction. We expect that 2020 will continue to be a pivotal year for our company as we continue to publish new data and expect to initiate our Phase 3 U.S. trial of cytisinicline later this year," added Stewart.

    About the RAUORA Study

    The RAUORA study was conducted by the researchers at the University of Auckland, in conjunction with the Health Economics Research Group (HERG) at Brunel University London, and Lakes District Health Board. Currently, 3 in 10 Māori smoke, three times more than non-Māori, and supporting this population to quit smoking is a priority of the New Zealand government. The study compared cytisinicline administered on a schedule of 25 days of downward dosing titration followed by twice-daily dosing for a total of 12 weeks with varenicline administered on a schedule of 7 days of upward titration followed by twice-daily dosing for a total of 12 weeks. The primary endpoint was continuous abstinence from smoking for 6 months post-quit date.

    In total, 1,105 Māori or whānau (Māori extended family members) expressed interest in participating in the study and a total of 679 were randomized to receive either cytisinicline or varenicline. The average age of participants in the trial was 43 years and approximately 70% of the participants were women. Contact was sought over a period of six to 12 months to collect data and support their quit journey.

    About Achieve and Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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, the timing, and nature of cytisinicline clinical development activities, the potential market size for cytisinicline and the potential benefits of cytisinicline. 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; impacts from the COVID-19 pandemic; 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.

    Media Contact                                 

    Glenn Silver

    Email:

    Telephone: 1 646 871 8485

    ® Chantix® is a registered trademark of Pfizer Inc.

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

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    SOURCE Achieve Life Sciences, Inc.

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  29. SEATTLE and VANCOUVER, British Columbia, May 14, 2020 /PRNewswire/ -- 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 addiction, today announced first quarter 2020 financial results and provided an update on the cytisinicline clinical development program.

    Recent Highlights

    • Submitted required non-clinical supportive data for longer cytisinicline treatment to the U.S. Food & Drug Administration (FDA) in preparation for Phase 3 cytisinicline ORCA-2 trial initiation
    • Closed financing for gross proceeds of approximately $1.9 million, prior to deducting placement agent commissions and estimated offering expenses
    • Presented new findings from the Phase 2b ORCA-1 trial evaluating cytisinicline in U.S. smokers at the Society for Research on Nicotine & Tobacco (SRNT) Annual Conference
    • Established agreement with the FreeMind Group to assist in securing non-dilutive funding to evaluate cytisinicline in vapers and e-cigarette users

    "The COVID-19 pandemic has revealed an increased risk for smokers due to the known relationship between smoking and respiratory illnesses and we see an even greater need to do all that we can to help them quit," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "We expect to initiate the 750 patient Phase 3 ORCA-2 trial in the second-half of 2020, subject to financing and the ability to conduct the trial safely in light of the COVID-19 pandemic."

    Completed FDA Submission 
    In preparation for initiation of the Phase 3 ORCA-2 clinical trial of cytisinicline, the Company has now submitted to FDA all requested non-clinical data to allow 6 and 12 weeks of cytisinicline treatment in the Phase 3 trials. No new safety or toxicology signals were observed in the non-clinical data evaluating either 13 or 26 weeks of cytisinicline treatment.

    Closed private placement financing for gross proceeds of $1.9 million
    In April 2020, Achieve announced it entered into definitive agreements for a private placement of its securities for gross proceeds of approximately $1.9 million, prior to deducting placement agent commissions and estimated offering expenses. The Company intends to use the proceeds to fund clinical research and development, and for general working capital.

    Additional ORCA-1 Results at SRNT Annual Conference  
    An oral presentation featuring new ORCA-1 Phase 2b trial analyses was presented at the SRNT Annual Meeting in March 2020. In addition to previously reported data indicating a statistically significant improvement in quit rates, new analyses demonstrate cytisinicline biochemical efficacy via measurement of serum cotinine as well as the previous carbon monoxide efficacy. Additionally, further analyses confirm that cytisinicline benefit was observed across all clinical sites, baseline characteristics, and attributes. Thus, regardless of trial site location, patient demographics, smoking history, or prior treatments, all subjects treated with cytisinicline showed similar smoking cessation benefit. 

    Agreement with the FreeMind Group to secure non-dilutive financing for vaping trials
    In the first quarter of 2020, Achieve retained the FreeMind Group, an international consulting firm dedicated to assisting life science organizations secure non-dilutive funding. Achieve and FreeMind are conducting a strategic assessment of potential non-dilutive funding opportunities from various public and private sources, followed by anticipated grant production and submission, to further the clinical development of cytisinicline in vaping or e-cigarette cessation.

    Financial Results
    As of March 31, 2020, the company's cash, cash equivalents, and restricted cash was $12.2 million. Total operating expenses for the quarter ended March 31, 2020 were $3.4 million. Total net loss for the quarter ended March 31, 2020 was $3.3 million.

    As of March 14, 2020, Achieve had 37,515,408 shares outstanding.

    Conference Call Details
    Achieve will host a conference call at 8:00 a.m. Eastern time today, Thursday, May 14, 2020. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 4477265. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 ability to secure any non-dilutive financing, the timing and nature of cytisinicline clinical development activities,  the potential market size for cytisinicline, the potential benefits 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.

    Achieve Contact  
    Jason Wong

    (415) 375-3340 ext. 4

    1  World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

     

    Consolidated Statements of Loss

    (In thousands, except per share and share data)




















    Three months ended March 31,



    2020



    2019

















    Operating expenses:








      Research and development



    1,541




    4,055

      General and administrative



    1,816




    1,885

        Total operating expenses



    3,357




    5,940

    Loss from operations



    (3,357)




    (5,940)

      Other income (expense)



    37




    36

    Net loss


    $

    (3,320)



    $

    (5,904)









    Basic and diluted net loss per share


    $

    (0.11)



    $

    (0.88)









    Weighted average number of basic and diluted common shares



    30,936,777




    6,721,184

















    Consolidated Balance Sheets

    (In thousands)











    March 31,



    December 31,



    2020



    2019









    Assets:








      Cash, cash equivalents, short term investments and restricted cash


    $

    12,206



    $

    16,714

      Prepaid expenses and other current assets



    746




    670

      Property, equipment and other assets



    345




    244

      Right-of-use assets



    285




    329

      License agreement



    2,031




    2,087

      Goodwill



    1,034




    1,034

    Total assets


    $

    16,647



    $

    21,078









    Liabilities and stockholders' equity:








      Accounts payable and accrued liabilities


    $

    1,348



    $

    2,666

      Current portion of long-term obligations



    196




    203

      Long-term obligations



    118




    159

      Stockholders' equity



    14,985




    18,050

    Total liabilities and stockholders' equity


    $

    16,647



    $

    21,078

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-reports-financial-results-for-first-quarter-2020-and-provides-update-on-cytisinicline-development-program-301058990.html

    SOURCE Achieve Life Sciences, Inc.

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  30. SEATTLE and VANCOUVER, British Columbia, May 5, 2020 /PRNewswire/ -- 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 addiction, today announced that it will report its first quarter 2020 financial results on Thursday, May 14, 2020. Company management will host a conference call and live webcast at 8:00 am Eastern Time to report financial results and provide an update on the cytisinicline clinical development program.

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 4477265. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days. 

    Achieve Contact 
    Jason Wong 
      
    (415) 375-3340 ext. 4 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-to-announce-first-quarter-2020-financial-results-and-host-conference-call-and-webcast-on-may-14-2020-301052442.html

    SOURCE Achieve Life Sciences, Inc.

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  31. SEATTLE and VANCOUVER, British Columbia, April 30, 2020 /PRNewswire/ -- 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 addiction, today announced that it has entered into definitive agreements for a private placement of its securities for gross proceeds of approximately $1.9 million, prior to deducting placement agent commissions and estimated offering expenses.

    The private placement will be for up to 5,615,653 units at a price of $0.33 per unit, with each unit consisting of one share of common stock and a warrant to purchase 0.75 shares of common stock.  The private placement will close in two tranches based on the execution of definitive documents on April 27, 2020 and April 28, 2020. The warrants for the first closing have an initial per share exercise price of $0.362, and the warrants for the second closing have an initial per share exercise price of $0.366.  All warrants will be exercisable beginning on the six-month anniversary of the initial closing of the offering and will have a five-year term. The Company intends to use the proceeds from the private placement to fund clinical research and development, and for general working capital.

    Paulson Investment Company, LLC, acted as the exclusive placement agent in connection with this offering.

    The Company has additionally agreed to file a registration statement to register the resale of the shares of common stock included in the units and underlying the investor and placement agent warrants within 60 days of the closing of the offering.

    The Company offered and sold the securities described above in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder. 

    About Achieve & Cytisinicline

    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 completion of the offering and the expected net proceeds of the offering. 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 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 law.

    Achieve Contact

    Jason Wong



    (415) 375-3340 ext. 4

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-announces-private-placement-of-1-9-million-301050616.html

    SOURCE Achieve Life Sciences, Inc.

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  32. - Will support Sera's Transition from clinical to commercial stage company -
    - Sera positioned for growth with several outcome study read-outs taking place in 2020 -

    SALT LAKE CITY, April 02, 2020 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., The Pregnancy Company™, focused on improving maternal and neonatal health through innovative precision biomarker approaches, today announced the appointment of Jay M. Moyes as Chief Financial Officer. Mr. Moyes joins Sera Prognostics as it transitions from rigorous scientific and groundbreaking clinical stage company into a rapidly growing commercial organization.

    For more than two decades, Jay Moyes has served in C-level executive and board positions of both private and public companies. He currently serves…

    - Will support Sera's Transition from clinical to commercial stage company -
    - Sera positioned for growth with several outcome study read-outs taking place in 2020 -

    SALT LAKE CITY, April 02, 2020 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., The Pregnancy Company™, focused on improving maternal and neonatal health through innovative precision biomarker approaches, today announced the appointment of Jay M. Moyes as Chief Financial Officer. Mr. Moyes joins Sera Prognostics as it transitions from rigorous scientific and groundbreaking clinical stage company into a rapidly growing commercial organization.

    For more than two decades, Jay Moyes has served in C-level executive and board positions of both private and public companies. He currently serves as Director on the public boards of Achieve Life Sciences (NASDAQ:ACHV), BioCardia (NASDAQ: BCDA) and Puma Biotechnologies (NASDAQ:PBYI). Previous roles include board director service with Predictive Technology Group (PRED); Osiris Therapeutics (OSIR); and Integrated Diagnostics (acquired by Biodesix). Jay also served as Chief Financial Officer and Director of the publicly traded biomaterials company, Amedica Corporation (now SINTX Technologies), managing the company's IPO and listing on NASDAQ; and as Chief Financial Officer at XDx (now CareDx – CDNA).  

    At Myriad Genetics (MYGN) , Jay led the finance function for 14 years from the company's early private stage development beginning with 7 employees, through its successful IPO in 1996, and serving until 2007 as Chief Financial Officer during Myriad's rapid growth trajectory to become one of the world's most highly profitable molecular diagnostics companies, with over 900 employees.  During that time, Moyes spearheaded the efforts in raising more than $500 million in public and private financings.

    "I am thrilled to be working with Jay Moyes again, as we build Sera Prognostics into a highly successful and profitable enterprise," said Gregory C. Critchfield, MD., MS, chairman and CEO. "Jay's deep financing connections and expertise in leading biopharmaceutical, medical device and diagnostics companies, both in private and public company settings, will help Sera to achieve its vision of improving the health of mothers and babies and reducing the costs of healthcare delivery."


    "I am excited to join the talented Sera team and help accelerate the company's progress, as Greg and I successfully did together at Myriad."

    -Jay Moyes

    Click to tweet

    "Sera has achieved remarkable progress in building a world-class approach to address the immense burden of premature birth," said Jay Moyes.  "The early data from outcome study reports show that Sera's PreTRM® strategy works, and that by improving the health of women and babies, the enormous personal, societal and economic consequences of prematurity can be mitigated.  I am excited to join the talented Sera team and help accelerate the company's progress, as Greg and I successfully did together at Myriad."

    A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/b1b82cc8-0a89-413b-bf84-1354b59a87da

    About Sera Prognostics, Inc.
    Sera Prognostics is the leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera delivers pivotal information in early pregnancy to physicians, enabling them to improve health of their patients, resulting in reductions in the costs healthcare delivery.  Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM® test reports to a physician the individualized risk of premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is located in Salt Lake City, Utah. For more information, please visit the company's website at www.seraprognostics.com.

    About Preterm Birth
    Preterm birth is defined as any birth before 37 weeks gestation and is the leading cause of illness and death in newborns.  The 2019 March of Dimes Report Card shows that of nearly 4 million babies born annually in the U.S., more than one in ten is born prematurely.1 Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual US health care costs to manage complications of prematurity were estimated at $31.5B for 2015.2

    About the PreTRM® Test
    The PreTRM® test is the only clinically validated commercially available blood test that provides an early individual risk prediction for spontaneous preterm birth in asymptomatic, singleton pregnancies. The PreTRM® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® test permits physicians to identify, as early as 19 weeks of pregnancy, which women are at increased risk for premature delivery, enabling more informed clinical decisions based on each woman's individual risk, so that her care can be personalized to address her risk. The PreTRM® test is ordered by a medical professional. For more information about the PreTRM® test, please visit www.PreTRM.com and the PreTRM® test YouTube Channel. You can also join the conversation on Facebook and @PreTRM.

    About Sera's Science
    Using its advanced mass spectrometry platform, Sera detects biologically important protein expression changes to build high performing predictions of risk for adverse pregnancy outcomes (including preterm birth, preeclampsia, gestational diabetes, growth restriction, and others).  Rigorous clinical validation of PreTRM® test performance (accuracy of predicting premature delivery) was reported in the American Journal of Obstetrics & Gynecology in 2016 in a US cohort of 5,501 patients across 11 centers.  Subsequent scientific work has confirmed performance of Sera's biomarker predictions in cohorts of patients across the globe: US, Europe, Asia and Africa, with over 10,500 patients tested in studies.

    About Clinical Outcomes Data
    Sera's validated PreTRM® prediction has been taken into prospective intervention studies, where populations of pregnant women have been screened by the Sera test.  Higher PreTRM®-risk pregnancies are stratified to receive earlier more proactive interventions, and important outcomes are examined in comparison to pregnancies in control groups where the test is not available. 

    Topline results showing the benefit of the PreTRM® strategy in a recently completed randomized controlled prospective intervention study (PREVENT PTB Study, NCT03530332) became available online for the Late Breaking Poster Session of the Annual Meeting of the Society of Reproductive Investigation, scheduled for March 14 in 2020 in Vancouver, Canada.

    1 http://www.marchofdimes.org/mission/prematurity-reportcard.aspx
    2 Caughey et al., Am J Perinatol Rep 2016;6:e407-e416

    Contacts:
    Fern Lazar, Lazar FINN

    212 867 1765          
    Chantal Beaudry, Lazar FINN

    646 871 8480

    Primary Logo

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  33. SEATTLE and VANCOUVER, British Columbia, March 13, 2020 /PRNewswire/ -- 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 addiction, today announced fourth quarter and year-end 2019 financial results and provided an update on the cytisinicline clinical development program.

    Recent Highlights

    • Completed meeting with the U.S. Food & Drug Administration (FDA) to finalize the Phase 3 cytisinicline clinical development program
    • Presented new findings from the Phase 2b ORCA-1 trial evaluating cytisinicline in U.S. smokers at the Society for Research on Nicotine & Tobacco (SRNT) Annual Conference in March 2020
    • Established agreement with the FreeMind Group to assist in securing non-dilutive funding to evaluate cytisinicline in vapers and e-cigarette users
    • Closed underwritten public offering for gross proceeds of $13.8 million, before underwriting discounts and commissions and offering expenses

    "With over 34 million smokers and nearly 11 million vape and e-cigarette users in the United States alone, the nicotine addiction epidemic continues to be a major public health crisis that Achieve is exclusively focused on addressing through the development of cytisinicline," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "Our key priorities in the coming months are to initiate the ORCA-2 Phase 3 clinical trial in smokers and secure non-dilutive financing to evaluate cytisinicline specifically in the growing population of vape users."

    Completed FDA Meeting
    In the fourth quarter of 2019, Achieve received feedback on the Phase 3 clinical trial protocols and the cytisinicline clinical development program. Specifically, the FDA agreed with the overall Phase 3 study designs that anticipate utilizing the simplified cytisinicline dosing schedule of 3.0 mg administered three times daily and the duration of 6 and 12 weeks of treatment. Additionally, the FDA agreed that no further escalation in cytisinicline dosing beyond the 30.0 mg dose was necessary for defining a maximum tolerated dose, which is required for the New Drug Application.

    Additional ORCA-1 Results at SRNT Annual Conference
    An oral presentation featuring new ORCA-1 Phase 2b trial analyses was presented at the SRNT Annual Meeting in March 2020. In addition to previously reported data indicating a statistically significant improvement in quit rates, new analyses demonstrate cytisinicline biochemical efficacy via measurement of serum cotinine as well as the previous carbon monoxide efficacy. Additionally, further analyses confirm that cytisinicline benefit was observed across all clinical sites, baseline characteristics, and attributes. Thus, regardless of trial site location, patient demographics, smoking history, or prior treatments, all subjects treated with cytisinicline showed similar smoking cessation benefit. 

    Agreement with the FreeMind Group to secure non-dilutive financing for vaping trials
    Achieve retained the FreeMind Group, an international consulting firm dedicated to assisting life science organizations secure non-dilutive funding. Achieve and FreeMind will conduct a strategic assessment of potential non-dilutive funding opportunities from various public and private sources, followed by anticipated grant production and submission, to further the clinical development of cytisinicline in vaping or e-cigarette cessation.

    Closed underwritten public offering for gross proceeds of $13.8 million
    In December 2019, Achieve announced the closing of an underwritten public offering that raised total gross proceeds of $13.8 million, which includes the full exercise of the underwriter's over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses.

    Financial Results
    As of December 31, 2019, the company's cash, cash equivalents, and restricted cash was $16.7 million. Total operating expenses for the fourth quarter and year ended December 31, 2019 were $3.2 million and $16.5 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2019 was $3.2 million and $16.4 million, respectively.

    As of March 13, 2020 Achieve had 31,352,764 shares outstanding.

    Conference Call Details
    Achieve will host a conference call at 8:30 a.m. Eastern time today, Friday, March 13, 2020. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6628874. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 ability to secure any non-dilutive financing, the timing and nature of cytisinicline clinical development activities,  the potential market size for cytisinicline, the potential benefits 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; 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.

    Achieve Contact                                              
    Jason Wong

    (415) 375-3340 ext. 4

    1  World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1











    Consolidated Statements of Loss

    (In thousands, except per share and share data)

























    Three months ended December 31,


    Twelve months ended December 31,




    2019


    2018


    2019


    2018

    Operating expenses:










      Research and development



    1,763


    2,081


    9,674


    5,868

      General and administrative



    1,446


    1,628


    6,854


    6,945

        Total operating expenses



    3,209


    3,709


    16,528


    12,813

    Loss from operations



    (3,209)


    (3,709)


    (16,528)


    (12,813)

      Other income (expense)



    15


    72


    133


    126

    Net loss



    $          (3,194)


    $       (3,637)


    $             (16,395)


    $             (12,687)











    Basic and diluted net loss per share



    $             (0.30)


    $          (0.55)


    $                   (1.99)


    $                   (3.61)











    Weighted average number of basic and diluted common shares



    10,802,186


    6,659,379


    8,246,400


    3,510,217





















    Consolidated Balance Sheets

    (In thousands)


















     December 31, 


     December 31, 








    2019


    2018

    Assets:










      Cash, cash equivalents, short term investments and restricted cash







    $               16,714


    $               14,654

      Prepaid expenses and other current assets







    670


    933

      Property, equipment and other assets







    244


    153

      Right-of-use assets







    329


      License agreement







    2,087


    2,310

      Goodwill







    1,034


    1,034

    Total assets







    $               21,078


    $               19,084











    Liabilities and stockholders' equity:










      Accounts payable and accrued liabilities







    $                  2,666


    $                  3,259

      Current portion of long-term obligations







    203


    11

      Long-term obligations







    159


    12

      Stockholders' equity







    18,050


    15,802

    Total liabilities and stockholders' equity







    $               21,078


    $               19,084











     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-reports-financial-results-for-fourth-quarter-and-year-end-2019-and-provides-update-on-cytisinicline-development-program-301022028.html

    SOURCE Achieve Life Sciences, Inc.

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  34. SEATTLE and VANCOUVER, British Columbia, March 12, 2020 /PRNewswire/ -- 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 addiction, announced that additional analyses from the ORCA-1 Phase 2b trial will be presented today, Thursday, March 12th, at the SRNT Annual Meeting in New Orleans.

    Previously reported data from the ORCA-1 trial of 254 smokers demonstrated significant quit rates in all cytisinicline-treated subjects compared to placebo, particularly in the 3.0 mg cytisinicline-treated three times daily (TID) arm. Smokers who received 3.0 mg cytisinicline dosed TID over 25 days demonstrated a 54% abstinence rate at week 4 compared to 16% for placebo (p < 0.0001). A 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline was also observed compared to 8% for placebo (p= 0.005).

    New analyses from the ORCA-1 trial indicate that the cytisinicline benefit, abstinence and reduction in number of cigarettes smoked, was consistently observed across all demographics, smoking history, and clinical trial locations. Additionally, clinical benefit was observed with cytisinicline regardless of prior smoking cessation treatments utilized, including Chantix® (varenicline), Zyban® (bupropion), or Nicotine Replacement Therapy (NRT). Smokers in the ORCA-1 trial had an average smoking history of 32.1 years, smoked 18 cigarettes per day, and had 4.5 previous quit attempts, indicating a highly nicotine-addicted population.

    New analyses also demonstrate cytisinicline biochemical efficacy via measurement of serum cotinine as well as the previously reported carbon monoxide (CO) efficacy. Similar to CO analyses, all subjects in the cytisinicline-treated arms had a statistically significant reduction in serum cotinine levels by the end of study treatment. Both expired CO and serum cotinine levels are biochemical products from cigarette smoking or metabolizing nicotine and were objective biochemical markers used in the study to assess cigarette smoking or nicotine intake.

    "The additional analyses further validate our belief that cytisinicline could be an effective aid to smoking cessation regardless of demographics, prior smoking history, or numerous quit attempts," stated Dr. Cindy Jacobs PhD, MD, Chief Medical Officer of Achieve. "With over 34 million smokers in the United States alone and the growing, global vaping epidemic, new potential treatment options like cytisinicline are desperately needed to treat nicotine addiction."

    Achieve plans to initiate the Phase 3 development program in mid-2020, subject to the availability of capital.  Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.com or www.orcaprogram.com.

    About Achieve & Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide[1]. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking[2]. Achieve's focus is to address the global smoking and nicotine addiction health epidemic and through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    About ORCA-1
    ORCA-1 is the first in Achieve's ORCA (Ongoing Research of Cytisinicline for Addiction) Program, which aims to evaluate the safety and effectiveness of cytisinicline for smoking cessation and potentially other addiction indications. The study was designed to evaluate the declining titration schedule, currently utilized in Central and Eastern Europe, compared to a simplified TID schedule at both the 1.5 mg and 3.0 mg cytisinicline doses compared to placebo. Positive ORCA-1 topline results were announced in June 2019 and enrolled 254 smokers at eight centers across the United States.

    Overall adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg TID arm, specifically. Cytisinicline was generally well-tolerated with no serious or severe adverse events (AEs) reported.

    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 activities,  the potential market size for cytisinicline, the potential benefits 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; 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 law. 

    Achieve Contact
    Jason Wong

    (415) 375-3340 ext. 4

    "ORCA" is a trademark of Achieve Life Sciences, Inc.
    Chantix® is a registered trademark of Pfizer Inc., Zyban® is registered trademark of the GlaxoSmithKline group of companies.

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

     

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    SOURCE Achieve Life Sciences, Inc.

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  35. SEATTLE and VANCOUVER, British Columbia, March 3, 2020 /PRNewswire/ -- 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 addiction, today announced it that it will report its fourth quarter and year-end 2019 financial results on Friday, March 13, 2020. Company management will host a conference call and live webcast at 8:30 am Eastern Time to report financial results and provide an update on the cytisinicline clinical development program.

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 6628874. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days. 

    Achieve Contact 
    Jason Wong 
      
    (415) 375-3340 ext. 4 

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    SOURCE Achieve Life Sciences, Inc.

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  36. SEATTLE and VANCOUVER, British Columbia, Feb. 6, 2020 /PRNewswire/ -- 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 addiction, today announced it has retained the FreeMind Group, an international consulting firm dedicated to assisting life science organizations secure non-dilutive funding.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    Achieve and FreeMind will conduct a strategic assessment of potential non-dilutive funding opportunities from various public and private sources, followed by anticipated grant production and submission, to further the clinical development of cytisinicline in vaping, or e-cigarette, cessation. The use of e-cigarettes…

    SEATTLE and VANCOUVER, British Columbia, Feb. 6, 2020 /PRNewswire/ -- 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 addiction, today announced it has retained the FreeMind Group, an international consulting firm dedicated to assisting life science organizations secure non-dilutive funding.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    Achieve and FreeMind will conduct a strategic assessment of potential non-dilutive funding opportunities from various public and private sources, followed by anticipated grant production and submission, to further the clinical development of cytisinicline in vaping, or e-cigarette, cessation. The use of e-cigarettes or vaping devices can avoid certain chemicals that are associated with cigarette smoking, but may have other associated health and safety issues. The emerging use of e-cigarettes is contributing to the growing population of people who are addicted to nicotine.  

    "Based on FreeMind's proven track record securing over 1.5 billion dollars to date in non-dilutive financing, we are optimistic in their ability to assist Achieve with this critical initiative," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "It is estimated that nearly 11 million adults in the U.S. alone are using e-cigarettes, and more than half are under the age of thirty-five. We strongly believe in the potential of cytisinicline, as a treatment for nicotine addiction, to address this emerging epidemic."

    About Achieve & Cytisinicline 
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking and nicotine addiction health epidemic and through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    About FreeMind Group
    The FreeMind Group is a premier international consulting firm that specializes in assisting life science organizations secure non-dilutive funding from US federal agencies, such as the National Institutes of Health and Department of Defense, and private foundations. Established in 1999, FreeMind is the largest consulting group of its kind and works with academics and research institutions as well as industry from all around the world. Services provided by the FreeMind Group include strategic assessment of available funding opportunities, assistance with application preparation, and reward negotiation. FreeMind's proven long-term, multi-submission, strategic approach has garnered its clients over 1.5 billion dollars to date.

    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 ability to secure any non-dilutive financing, the timing and nature of cytisinicline clinical development activities,  the potential market size for cytisinicline, the potential benefits 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; 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 law. 

    Achieve Contact
    Jason Wong
     
    (415) 375-3340 ext. 4

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017 
    Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

     

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    SOURCE Achieve Life Sciences, Inc.

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  37. SEATTLE and VANCOUVER, British Columbia, Jan. 13, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), University of Bristol, and Oracle Corporation (NYSE:ORCL) today announced the outcome of a study using Oracle's high-performance cloud infrastructure to potentially improve the speed of drug discovery and development of new treatments.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    The study, "A General Mechanism for Signal Propagation in the Nicotinic Acetylcholine Receptor Family," was led by scientists from the University of Bristol and recently published in the Journal of the American Chemical Society. It aimed to evaluate how receptors in the brain respond to nicotine. Researchers utilized new computational simulation methods to conduct 450 individual assessments of…

    SEATTLE and VANCOUVER, British Columbia, Jan. 13, 2020 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), University of Bristol, and Oracle Corporation (NYSE:ORCL) today announced the outcome of a study using Oracle's high-performance cloud infrastructure to potentially improve the speed of drug discovery and development of new treatments.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    The study, "A General Mechanism for Signal Propagation in the Nicotinic Acetylcholine Receptor Family," was led by scientists from the University of Bristol and recently published in the Journal of the American Chemical Society. It aimed to evaluate how receptors in the brain respond to nicotine. Researchers utilized new computational simulation methods to conduct 450 individual assessments of the biochemistry associated with the binding of nicotine to a subtype of nicotinic acetylcholine receptors, a key mechanism believed to be responsible for the highly-addictive nature of nicotine.

    Computations that would otherwise have taken months to complete were achieved in five days using Oracle's high-performance cloud infrastructure. The speed of results represents a breakthrough in computational chemistry and is transformational from a research perspective.

    "To understand why nicotine is so addictive, and to develop molecules to help people quit smoking, we need to understand how nicotine affects the nervous system," commented Professor Adrian Mulholland from Bristol's Centre for Computational Chemistry and co-author of the study. "By harnessing the power of cloud computing, we can quickly observe how nicotine exerts its effects at the molecular level. This information can inform future drug development of new treatments for companies like Achieve."

    Achieve Life Sciences has partnered with the University of Bristol to formulate molecules and potential treatments to combat addiction and neurological disorders based on their lead smoking cessation compound in development, cytisinicline. Building on this research and previously conducted studies, cloud-based computer simulations can now be utilized to evaluate the effectiveness of potential new treatments more efficiently and help to accelerate the pace of discovery.

    About Achieve & Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide.1 It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking.2 Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 activities,  the potential market size for cytisinicline, the potential benefits of cytisinicline, the ability to discover and develop new uses for cytisinicline 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; 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 law. 

    Achieve Contact
    Jason Wong

    (415) 375-3340 ext. 4

    1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

     

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    SOURCE Achieve Life Sciences, Inc.

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  38. SEATTLE and VANCOUVER, British Columbia, Dec. 19, 2019 /PRNewswire/ -- 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 addiction, today announced the closing of an underwritten public offering of units for gross proceeds of $13.8 million, which includes the full exercise of the underwriter's over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and estimated offering expenses.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    The offering was comprised of Class A units, priced at a public offering price of $0.60 per unit, with each unit consisting of one share of common stock…

    SEATTLE and VANCOUVER, British Columbia, Dec. 19, 2019 /PRNewswire/ -- 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 addiction, today announced the closing of an underwritten public offering of units for gross proceeds of $13.8 million, which includes the full exercise of the underwriter's over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and estimated offering expenses.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    The offering was comprised of Class A units, priced at a public offering price of $0.60 per unit, with each unit consisting of one share of common stock and a five-year warrant to purchase one share of common stock with an exercise price of $0.60 per share, and Class B units, priced at a public offering price of $999.60 per unit, with each unit comprised of one share of Series B preferred stock, which is convertible into 1,666 shares of common stock, and a five-year warrant to purchase 1,666 shares of common stock, also with an exercise price of $0.60 per share. The Series B preferred stock issued in this transaction include a beneficial ownership blocker but have no dividend rights (except to the extent that dividends are also paid on the common stock), liquidation preference or other preferences over common stock, and, subject to limited exceptions, have no voting rights. The securities comprising the units will be immediately separable and issued separately.

    Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSEAmerican: LTS), acted as sole book-running manager in connection with the offering.

    A total of 12,577,504 shares of common stock, 6,256 shares of Series B preferred stock convertible into an aggregate of 10,422,496 shares of common stock, and total warrants to purchase 23,000,000 shares of common stock were issued in the offering.

    The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-234530), which was declared effective by the Securities and Exchange Commission (SEC) on December 17, 2019.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to this offering was filed by Achieve with the SEC. Copies of the final prospectus can be obtained at the SEC's website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000.

    About Achieve & Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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. 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 Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and Achieve's registration statement on Form S-1 (File No. 333-234530), as amended. 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 law.

    Achieve Contact
    Jason Wong

    (415) 375-3340 ext. 4

    1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

     

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    SOURCE Achieve Life Sciences, Inc.

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  39. SEATTLE and VANCOUVER, British Columbia, Dec. 17, 2019 /PRNewswire/ -- 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 addiction, today announced the pricing of an underwritten public offering of units for gross proceeds of $12 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. The offering is expected to close on December 19, 2019, subject to customary closing conditions.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    The offering is comprised of Class A units, priced at a public offering price of $0.60 per unit, with each unit consisting of one share of common stock and a five-year warrant to…

    SEATTLE and VANCOUVER, British Columbia, Dec. 17, 2019 /PRNewswire/ -- 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 addiction, today announced the pricing of an underwritten public offering of units for gross proceeds of $12 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. The offering is expected to close on December 19, 2019, subject to customary closing conditions.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    The offering is comprised of Class A units, priced at a public offering price of $0.60 per unit, with each unit consisting of one share of common stock and a five-year warrant to purchase one share of common stock with an exercise price of $0.60 per share, and Class B units, priced at a public offering price of $999.60 per unit, with each unit comprised of one share of Series B preferred stock, which is convertible into 1,666 shares of common stock, and a five-year warrant to purchase 1,666 shares of common stock, also with an exercise price of $0.60 per share. The Series B preferred stock to be issued in this transaction will include a beneficial ownership blocker but will have no dividend rights (except to the extent that dividends are also paid on the common stock), liquidation preference or other preferences over common stock, and, subject to limited exceptions, will have no voting rights. The securities comprising the units will be immediately separable and issued separately.

    Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc., is the sole book-running manager in connection with the offering.

    A total of 9,577,504 shares of common stock, 6,256 shares of Series B preferred stock convertible into an aggregate of 10,422,496 shares of common stock, and total warrants to purchase 20,000,000 shares of common stock will be issued in the offering.

    In addition, Achieve has granted the underwriters a 45-day option to purchase up to 3,000,000 additional shares of common stock and/or warrants to purchase up to 3,000,000 shares of common stock solely to cover overallotments, if any, at the public offering price per share and per warrant, less the underwriting discounts and commissions.

    The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-234530), which was declared effective by the Securities and Exchange Commission (SEC) on December 17, 2019.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to this offering will be filed by Achieve with the SEC. When available, copies of the final prospectus can be obtained at the SEC's website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 277 Park Avenue, 26th Floor, New York, New York 10172, by calling (212) 409-2000.

    About Achieve & Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 completion of the underwritten offering, the potential exercise of overallotment option, the expected net proceeds of the offering. 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 Achieve's Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and Achieve's registration statement on Form S-1 (File No. 333-234530), as amended. 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 law.

    Achieve Contact
    Jason Wong

    (415) 375-3340 ext. 4

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

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    SOURCE Achieve Life Sciences, Inc.

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  40. SEATTLE and VANCOUVER, British Columbia, Dec. 9, 2019 /PRNewswire/ -- 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 addiction, today announced an update on the cytisinicline clinical development program.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    Following discussions with the Food and Drug Administration (FDA), Achieve has received feedback on the final Phase 3 clinical trial protocols and the cytisinicline clinical development program. Specifically, the FDA has agreed with the overall Phase 3 study designs that will utilize the simplified cytisinicline dosing schedule of 3.0 mg administered three times daily and the duration of 6 and…

    SEATTLE and VANCOUVER, British Columbia, Dec. 9, 2019 /PRNewswire/ -- 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 addiction, today announced an update on the cytisinicline clinical development program.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    Following discussions with the Food and Drug Administration (FDA), Achieve has received feedback on the final Phase 3 clinical trial protocols and the cytisinicline clinical development program. Specifically, the FDA has agreed with the overall Phase 3 study designs that will utilize the simplified cytisinicline dosing schedule of 3.0 mg administered three times daily and the duration of 6 and 12 weeks of treatment. The FDA also agreed that the use of the newly-developed, single 3.0 mg cytisinicline tablet in the Phase 3 program was acceptable.

    Minimal changes to the Phase 3 protocol were discussed and agreed upon by both Achieve and the FDA. No changes were required for the primary and secondary analyses. Achieve agreed to complete a second chronic toxicology study supporting the 12 weeks of treatment prior to initiating the Phase 3 program. The chronic toxicology study report is expected to be available and submitted to the FDA in the first quarter of 2020.

    The FDA agreed that no further escalation in cytisinicline dosing beyond the 30.0 mg dose was necessary for defining a maximum tolerated dose, which is required for the New Drug Application (NDA).

    "We are extremely appreciative of the collaborative and successful discussions with the FDA at the meeting and look forward to submitting the final non-clinical requirements and initiating the Phase 3 program in the first half of 2020," commented Dr. Cindy Jacobs, Chief Medical Officer of Achieve.

    Achieve previously announced results of the Phase 2b ORCA-1 trial evaluating cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the United States. Topline results demonstrated a 54% abstinence rate at week 4 in the 3.0 mg three times daily (TID) cytisinicline arm compared to 16% for placebo (p < 0.0001). Additionally, for the 3.0 mg TID cytisinicline arm, a 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline was observed compared to 8% for placebo (p= 0.005). Continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval and will be the primary endpoint in the planned Phase 3 trials.

    Overall adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg TID arm, specifically. Cytisinicline was generally well-tolerated with no serious or severe adverse events (AEs) reported. Overall, in subjects treated with cytisinicline, all individual AEs reported were below a rate of 10%. Minimal rates of abnormal dreams, insomnia, upper respiratory tract infections, and nausea were reported compared with placebo.

    Achieve plans to initiate the Phase 3 development program in 2020, subject to the availability of capital.  Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.com.

    About Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    About ORCA-1
    ORCA-1 is the first in Achieve's ORCA (Ongoing Research of Cytisinicline for Addiction) Program, which aims to evaluate the safety and effectiveness of cytisinicline for smoking cessation and potentially other addiction indications. The study was designed to evaluate the declining titration schedule, currently utilized in Central and Eastern Europe, compared to a simplified TID schedule at both the 1.5 mg and 3 mg cytisinicline doses compared to placebo. ORCA-1 topline results were announced in June 2019 and enrolled 254 smokers at eight centers across 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 planned cytisinicline clinical development activities, the timing of clinical development activities related to cytisinicline, the potential market size for cytisinicline and the potential benefits of cytisinicline. 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; 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 law.

    Achieve Contact
    Jason Wong
     
    (415) 375-3340 ext. 4

    "ORCA" is a trademark of Achieve Life Sciences, Inc.

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology, Volume 25, Issue 3, 179 - 182.e1

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    SOURCE Achieve Life Sciences, Inc.

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  41. SEATTLE and VANCOUVER, British Columbia, Nov. 6, 2019 /PRNewswire/ -- 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 addiction, today provided an update on the cytisinicline clinical development program and announced third quarter 2019 financial results.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    Q3 2019 Highlights

    • Announced extension of a strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). As part of the collaboration, the NIH is funding and providing research efforts to conduct additional non-clinical development as requested by the FDA to support…

    SEATTLE and VANCOUVER, British Columbia, Nov. 6, 2019 /PRNewswire/ -- 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 addiction, today provided an update on the cytisinicline clinical development program and announced third quarter 2019 financial results.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    Q3 2019 Highlights

    • Announced extension of a strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). As part of the collaboration, the NIH is funding and providing research efforts to conduct additional non-clinical development as requested by the FDA to support cytisinicline's New Drug Application (NDA).
    • Presented positive efficacy and compliance results from the Phase 2b ORCA-1 dose-selection trial evaluating cytisinicline in 254 smokers at the Society for Research on Nicotine & Tobacco Europe (SRNT-E) 19th Annual Conference. Cytisinicline demonstrated a statistically significant improvement in quit rates for a simplified 3.0 mg, three times daily dose and was well-tolerated with no serious adverse events reported.
    • Hosted Company's first Investor Day, including roundtable discussion with smoking cessation medical experts and presentation of final ORCA-1 data, including plans for Phase 3 development program.
    • Presented at the H.C. Wainwright 21st Annual Global Investment Conference and the Ladenburg Thalmann 2019 Healthcare Conference.

    "It has been a busy and eventful quarter with progressive data analysis further reinforcing the strength of the ORCA-1 Phase 2b trial and the potential for cytisinicline as a new treatment for the millions of people who are battling nicotine addiction," commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. "Our key priority in the fourth quarter is to advance the ongoing, extensive preparations for the Phase 3 clinical trials, including our upcoming meeting with the FDA to finalize the cytisinicline Phase 3 protocols." 

    Extended Collaboration with NIH
    In July, Achieve announced an extension of its strategic collaboration with the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH). Under the extended collaboration, the NIH is funding and providing research efforts to conduct additional non-clinical studies as requested by the U.S. Food and Drug Administration (FDA) to be included in a cytisinicline New Drug Application (NDA). In discussions with the FDA in 2018, it was determined that a Good Laboratory Practice (GLP) non-clinical reproductive study would be required to support the NDA submission. NCCIH has agreed to sponsor this study which is expected to complete in 2020.  In total, the NIH has committed approximately $6 million dollars to the development of cytisinicline.

    Presented Final ORCA-1 Data at SRNT-E Conference
    Achieve's Chief Scientific Officer, Dr. Anthony Clarke, facilitated two oral presentations featuring data from the Phase 2b ORCA-1 trial at the SRNT-E Annual Conference in Oslo. The ORCA-1 trial of cytisinicline in 254 U.S. smokers demonstrated a statistically significant improvement in quit rates for the 3.0 mg, three times daily dosing (TID) schedule. In the 3.0 mg TID arm, a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) was observed. Continuous abstinence at weeks 5 through 8 was 30% for cytisinicline compared to 8% for placebo (p= 0.005). Adherence to study treatment was 98% in the 3.0 mg TID arm and cytisinicline was well-tolerated with no serious adverse events reported.

    Investor Day and KOL Roundtable Discussion
    The Company hosted its first investor day on September 20th, 2019, featuring an updated ORCA-1 data presentation and a roundtable discussion of smoking cessation medical experts, Dr. Mitchell Nides, Dr. Nancy Rigotti, Dr. Judith Prochaska, and Dr. Scott Leischow. The experts highlighted the critical need for the availability of new treatments, like cytisinicline, as an aid to smoking cessation. A replay of the event can be found at http://ir.achievelifesciences.com/events-and-webcasts.

    Financial Results
    As of September 30, 2019, the company's cash, cash equivalents, and restricted cash was $7.4 million. Total operating expenses for the three and nine months ended September 30, 2019 were $3.7 million and $13.3 million, respectively. Total net loss for the three and nine months ended September 30, 2019 was $3.7 million and $13.2 million, respectively.

    As of November 6, 2019 Achieve had 8,352,764 shares outstanding.

    Conference Call Details
    Achieve will host a conference call at 8:00 a.m. Eastern time today, Wednesday, November 6, 2019. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 7196429. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

    About Achieve and Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for more than eight million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    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 planned cytisinicline clinical development activities, the timing of clinical development activities related to cytisinicline, expectations from current data, expectations regarding when trial data may be reported, the potential market size for cytisinicline and the potential benefits of cytisinicline. 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; 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.

    Achieve Contact
    Jason Wong

    (415) 375-3340 ext. 4

    "ORCA" is a trademark of Achieve Life Sciences, Inc.

    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology , Volume 25 , Issue 3 , 179 - 182.e1

     

    Consolidated Statements of Loss

    (In thousands, except per share and share data)










    Three months ended September 30,


    Nine months ended September 30,


    2019


    2018


    2019


    2018

    Operating expenses:








      Research and development

    1,824


    1,541


    7,911


    3,787

      General and administrative

    1,893


    1,753


    5,408


    5,317

        Total operating expenses

    3,717


    3,294


    13,319


    9,104

    Loss from operations

    (3,717)


    (3,294)


    (13,319)


    (9,104)

      Other income (expense)

    44


    54


    118


    54

    Net loss

    $                          (3,673)


    $                    (3,240)


    $                              (13,201)


    $                            (9,050)









    Basic and diluted net loss per share

    $                            (0.45)


    $                      (0.71)


    $                                  (1.80)


    $                              (3.70)









    Weighted average number of basic and diluted common shares

    8,100,249


    4,533,943


    7,342,087


    2,448,962











     

    Consolidated Balance Sheets

    (In thousands)






     September 30,


     December 31,


    2019


    2018





    Assets:




      Cash, cash equivalents, short term investments and restricted cash

    $                                 7,425


    $                           14,654

      Prepaid expenses and other current assets

    264


    933

      Property, equipment and other assets

    254


    153

      Right-of-use assets

    372


      License agreement

    2,143


    2,310

      Goodwill

    1,034


    1,034

    Total assets

    $                               11,492


    $                           19,084





    Liabilities and stockholders' equity:




      Accounts payable and accrued liabilities

    $                                 2,941


    $                             3,259

      Current portion of long-term obligations

    198


    11

      Long-term obligations

    212


    12

      Stockholders' equity

    8,141


    15,802

    Total liabilities and stockholders' equity

    $                               11,492


    $                           19,084





     

     

     

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    SOURCE Achieve Life Sciences, Inc.

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  42. SEATTLE and VANCOUVER, British Columbia, Oct. 31, 2019 /PRNewswire/ -- 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 addiction, today announced that it will report its third quarter 2019 financial results on Wednesday, November 6, 2019. Company management will host a conference call and live webcast at 8:00am Eastern Time to report financial results and provide an update on the cytisinicline clinical development program.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the…

    SEATTLE and VANCOUVER, British Columbia, Oct. 31, 2019 /PRNewswire/ -- 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 addiction, today announced that it will report its third quarter 2019 financial results on Wednesday, November 6, 2019. Company management will host a conference call and live webcast at 8:00am Eastern Time to report financial results and provide an update on the cytisinicline clinical development program.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    To access the webcast, log on to the Investor Relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 7196429. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days. 

    Achieve Contact 
    Jason Wong 
     
    (415) 375-3340 ext. 4 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-to-announce-third-quarter-2019-financial-results-and-host-conference-call-and-webcast-on-november-6-2019-300948604.html

    SOURCE Achieve Life Sciences, Inc.

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  43. SEATTLE, Wash. and VANCOUVER, British Columbia, Oct. 24, 2019 /PRNewswire/ -- 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 addiction, today announced that data from the Phase 2b ORCA-1 trial will be presented at the SRNT-O Inaugural Conference.  

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    "Successful Smoking Abstinence with Cytisinicline in the ORCA-1 Trial: What Happens Next?" will be presented at the SRNT-O meeting by Achieve's Chief Scientific Officer, Dr. Anthony Clarke, on Friday, October 25th in Sydney. The results of the ORCA-1 trial, to be discussed in the presentation, confirm that future Phase 3 clinical trials are expected to…

    SEATTLE, Wash. and VANCOUVER, British Columbia, Oct. 24, 2019 /PRNewswire/ -- 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 addiction, today announced that data from the Phase 2b ORCA-1 trial will be presented at the SRNT-O Inaugural Conference.  

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    "Successful Smoking Abstinence with Cytisinicline in the ORCA-1 Trial: What Happens Next?" will be presented at the SRNT-O meeting by Achieve's Chief Scientific Officer, Dr. Anthony Clarke, on Friday, October 25th in Sydney. The results of the ORCA-1 trial, to be discussed in the presentation, confirm that future Phase 3 clinical trials are expected to utilize 3.0 mg TID dosing of cytisinicline. The Company plans to extend dosing in the Phase 3 trials from 25 days to 42 days, or six weeks. The slightly longer dosing will allow for the primary endpoint of continuous abstinence over 4 weeks to be measured while subjects are still on treatment and potentially improve quit rates.

    ORCA-1 was designed to evaluate cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the United States. Topline results, reported earlier this year, demonstrated a 54% abstinence rate at week 4 in the 3.0 mg three times daily (TID) cytisinicline arm compared to 16% for placebo (p < 0.0001). Additionally for the 3.0 mg TID cytisinicline arm, a 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline was observed compared to 8% for placebo (p= 0.005). Continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval.

    Overall adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg TID arm, specifically. Cytisinicline was well-tolerated with no serious or severe adverse events (AEs) reported. Overall, in subjects treated with cytisinicline, all individual AE's reported were below a rate of 10%. Minimal rates of abnormal dreams, insomnia, upper respiratory tract infections, and nausea were reported compared with placebo.

    The Company plans to initiate the Phase 3 development program in 2020, subject to the availability of capital. Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.com.

    About Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for nearly seven million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    About ORCA-1
    ORCA-1 is the first in Achieve's ORCA (Ongoing Research of Cytisinicline for Addiction) Program, which aims to evaluate the safety and effectiveness of cytisinicline for smoking cessation and potentially other addiction indications. The study was designed to evaluate the declining titration schedule, currently utilized in Central and Eastern Europe, compared to a simplified TID schedule at both the 1.5 mg and 3 mg cytisinicline doses compared to placebo. ORCA-1 topline results were announced in June 2019 and enrolled 254 smokers at eight centers across 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 planned cytisinicline clinical development activities, the timing of clinical development activities related to cytisinicline, the potential market size for cytisinicline and the potential benefits of cytisinicline. 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; 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 law.

    Achieve Contact
    Jason Wong
     
    (415) 375-3340 ext. 4

    "ORCA is a trademark of Achieve Life Sciences, Inc."


    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2017. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology , Volume 25 , Issue 3 , 179 - 182.e1

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    SOURCE Achieve Life Sciences, Inc.

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  44. SEATTLE and VANCOUVER, British Columbia, Sept. 30, 2019 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced completion of their maximum tolerated dose (MTD) study. The results indicate a lack of dose-limiting toxicity as defined by protocol criteria even at the highest 30 mg single, oral dose of cytisinicline evaluated in the study.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    This study, initiated in March 2019, is required by the FDA as part of a New Drug Application (NDA) for marketing approval in the United States. It was designed to determine dose-limiting adverse events (AEs) and to define the maximum tolerated dose for…

    SEATTLE and VANCOUVER, British Columbia, Sept. 30, 2019 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced completion of their maximum tolerated dose (MTD) study. The results indicate a lack of dose-limiting toxicity as defined by protocol criteria even at the highest 30 mg single, oral dose of cytisinicline evaluated in the study.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    This study, initiated in March 2019, is required by the FDA as part of a New Drug Application (NDA) for marketing approval in the United States. It was designed to determine dose-limiting adverse events (AEs) and to define the maximum tolerated dose for a single, oral dose of cytisinicline.

    An independent Data Safety Monitoring Committee (DSMC) composed of the Study Investigator and two independent physicians evaluated all safety outcomes before each dose escalation. Stopping criteria for further dose escalation was defined as the occurrence of severe or serious AEs or any other safety information considered as a concern. 

    The starting dose was 6 mg, which increased in 3 mg increments up to 21 mg.  When the MTD was not reached at 21 mg, the study was amended to evaluate doses up to 30 mg. At this dose, the stopping criteria of serious or severe AEs were still not met, but the DSMC recommended stopping the study. The results will be reviewed with the FDA to determine if further escalation beyond 30 mg will be required.

    "Cytisinicline continues to demonstrate an impressive safety profile, as seen in this study and in our recently announced Phase 2b ORCA-1 trial in smokers," stated Dr. Cindy Jacobs, Chief Medical Officer of Achieve. "Side effects are often a key limitation to existing smoking cessation treatments and we believe cytisinicline continues to offer an improved tolerability profile, compared to currently available medications." 

    The MTD has not been previously defined for cytisinicline. These results do not impact the intended 3 mg, 3 times daily dosing planned for future Phase 3 cytisinicline clinical trials, but rather demonstrate the lack of dose-limiting toxicity at doses up to 10 times higher than the planned 3 mg dose.

    Additional information on cytisinicline can be found at www.achievelifesciences.com and www.orcaprogram.com

    About Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for nearly seven million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    About Cytisinicline MTD Study

    The MTD study was a single-center, randomized, placebo-controlled, single dose-escalation, Phase 1 clinical study in adult smokers. The starting dose was 6 mg, which increased in 3 mg increments up to 21 mg. Following the absence of dose-limiting adverse events at 21 mg, the study was amended to evaluate doses up to 30 mg of cytisinicline, as the highest dose level of cytisinicline to be evaluated.

    An independent Data Safety Monitoring Committee (DSMC) composed of the Study Investigator and two independent physicians having expertise in treating smoking cessation evaluated all safety outcomes before each dose escalation. Stopping criteria for further dose escalation was defined as any one of the following occurring: severe or serious adverse events or any other safety information considered as a concern.  Pharmacokinetic parameters were also assessed at each dose level.

    While the stopping criteria of serious or severe adverse events were not met at the 30 mg dose, the DSMC indicated the frequency of gastrointestinal symptoms were approaching a maximum tolerated dose.  Additionally, by the final dosing cohort, the pharmacokinetic results showed a progressive reduction in any increase in the maximum blood concentrations (Cmax) levels, with evidence that the Cmax was approaching, or had reached, a plateau.

    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 planned cytisinicline clinical development activities, the timing of clinical development activities related to cytisinicline, the potential market size for cytisinicline and the potential benefits of cytisinicline. 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; 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 law.

    Achieve Contact
    Jason Wong
     
    (415) 375-3340 ext. 4

    "ORCA is a trademark of Achieve Life Sciences, Inc."

    1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2017. Geneva: World Health Organization, 2017

    2 Annals of Epidemiology , Volume 25 , Issue 3 , 179 - 182.e1

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-announces-completion-of-maximum-tolerated-dose-study-300927122.html

    SOURCE Achieve Life Sciences, Inc.

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  45. SEATTLE and VANCOUVER, British Columbia, Sept. 13, 2019 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that two presentations featuring final data from the Phase 2b ORCA-1 trial will be conducted at the SRNT-E Annual Conference on Friday, September 13th in Oslo.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    ORCA-1 was designed to evaluate cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the United States. Topline results, reported in June of 2019, have led to the selection of 3.0 mg, three times daily (TID) dosing for future Phase 3 development.

    The 3.0 mg TID treatment…

    SEATTLE and VANCOUVER, British Columbia, Sept. 13, 2019 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that two presentations featuring final data from the Phase 2b ORCA-1 trial will be conducted at the SRNT-E Annual Conference on Friday, September 13th in Oslo.

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    ORCA-1 was designed to evaluate cytisinicline efficacy and safety across various dosing and administration schedules in 254 smokers in the United States. Topline results, reported in June of 2019, have led to the selection of 3.0 mg, three times daily (TID) dosing for future Phase 3 development.

    The 3.0 mg TID treatment arm demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) and a 4-week continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline compared to 8% for placebo (p= 0.005). Continuous abstinence for 4 weeks is the relevant endpoint for regulatory approval.

    Final data included in the oral presentations at SRNT-E indicate statistically significant end-of-treatment abstinence rates of 50-54% for all cytisinicline treatment arms compared to 16% for placebo. Subjects had smoked on average for over 30 years. There were no differences observed in treatment outcomes based on subject demographics, clinical site location, number of prior smoking cessation treatments, or previous quit attempts.

    Overall adherence to study treatment was greater than 94% across all treatment arms and 98% in the 3.0 mg TID arm, specifically. Cytisinicline was well-tolerated with no serious or severe adverse events (AEs) reported. Overall, in subjects treated with cytisinicline, all individual AE's reported were below a rate of 10%. Minimal rates of abnormal dreams, insomnia, upper respiratory tract infections, and nausea were reported compared with placebo.

    Achieve Life Sciences will host an investor day with smoking cessation opinion leaders on Friday, September 20, 2019 in New York City to further review and discuss the outcomes of the ORCA-1 trial. The Investor Day will start at 12PM ET and will be 2 hours in duration. This is an RSVP-only event open to members of the investment community. Additional details and registration information is available at the Achieve website, http://ir.achievelifesciences.com/events-and-webcasts.

    Additional information on cytisinicline and the ORCA program can be found at www.achievelifesciences.com and www.orcaprogram.com.

    About Cytisinicline
    Tobacco use is currently the leading cause of preventable death and is responsible for nearly seven million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2. Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline.

    Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    About ORCA-1
    ORCA-1 is the first in Achieve's ORCA (Ongoing Research of Cytisinicline for Addiction) Program, which aims to evaluate the safety and effectiveness of cytisinicline for smoking cessation and potentially other addiction indications. The study was designed to evaluate the declining titration schedule, currently utilized in Central and Eastern Europe, compared to a simplified TID schedule at both the 1.5 mg and 3 mg cytisinicline doses compared to placebo. ORCA-1 topline results were announced in June 2019 and enrolled 254 smokers at eight centers across 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 planned cytisinicline clinical development activities, the timing of clinical development activities related to cytisinicline, the potential market size for cytisinicline and the potential benefits of cytisinicline. 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; 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 law.

    Achieve Contact
    Jason Wong
     
    (415) 375-3340 ext. 4

    "ORCA is a trademark of Achieve Life Sciences, Inc."



    1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2017. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology , Volume 25 , Issue 3 , 179 - 182.e1

     

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    SOURCE Achieve Life Sciences, Inc.

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  46. SEATTLE and VANCOUVER, British Columbia, Sept. 5, 2019 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced the Company will host its first investor day on Friday, September 20, 2019 in New York City. 

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    The event will include an updated data presentation by the primary investigator of the Phase 2b ORCA-1 trial of cytisinicline. It will also feature a panel discussion moderated by leading healthcare analysts, Michael Higgins from Ladenburg Thalmann and Jason McCarthy from Maxim Group, with participation from four esteemed medical experts in the field of smoking cessation.

    In June of…

    SEATTLE and VANCOUVER, British Columbia, Sept. 5, 2019 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced the Company will host its first investor day on Friday, September 20, 2019 in New York City. 

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

    The event will include an updated data presentation by the primary investigator of the Phase 2b ORCA-1 trial of cytisinicline. It will also feature a panel discussion moderated by leading healthcare analysts, Michael Higgins from Ladenburg Thalmann and Jason McCarthy from Maxim Group, with participation from four esteemed medical experts in the field of smoking cessation.

    In June of 2019, Achieve Life Sciences announced statistically significant, topline results from its 254-subject, Phase 2b ORCA-1 dose-selection trial of cytisinicline for smoking cessation. The outcome of the trial has led to the selection of 3.0 mg, three times daily (TID) dosing for future Phase 3 development. Cytisinicline treatment demonstrated significant improvements across all treatment arms in both reduction in cigarettes smoked and abstinence rates compared to placebo. The most impressive results were observed in the 3 mg TID treatment arm which demonstrated a 54% abstinence rate at week 4, compared to 16% for placebo (p < 0.0001) and a continuous abstinence rate, weeks 5 through 8, of 30% for cytisinicline compared to 8% for placebo (p= 0.005). Four week continuous abstinence is the relevant endpoint for regulatory approval.

    The Investor Day will start at 12PM ET and will be 2 hours in duration. This is an RSVP-only event open to members of the investment community. Additional details and registration information is available at the Achieve website, http://ir.achievelifesciences.com/events-and-webcasts.

    About Achieve Life Sciences
    Tobacco use is currently the leading cause of preventable death and is responsible for nearly seven million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2.

    Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    Achieve Contact
    Jason Wong
     
    (415) 375-3340 ext. 4

    1  World Health Organization. WHO Report on the Global Tobacco Epidemic, 2017. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology , Volume 25 , Issue 3 , 179 - 182.e1

     

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    SOURCE Achieve Life Sciences, Inc.

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  47. SEATTLE and VANCOUVER, British Columbia, Sept. 4, 2019 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that John Bencich, Chief Financial and Operating Officer, will present at two upcoming investor conferences.

    • H.C. Wainwright 21st Annual Global Investment Conference on Tuesday, September 10 at the Lotte New York Palace Hotel
    • Ladenburg Thalmann 2019 Healthcare Conference on Tuesday, September 24 at the Sofitel New York

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

     A live webcast can be accessed at http://ir.achievelifesciences.com/events-and-webcasts. A replay of the presentations will be archived on Achieve's website…

    SEATTLE and VANCOUVER, British Columbia, Sept. 4, 2019 /PRNewswire/ -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, today announced that John Bencich, Chief Financial and Operating Officer, will present at two upcoming investor conferences.

    • H.C. Wainwright 21st Annual Global Investment Conference on Tuesday, September 10 at the Lotte New York Palace Hotel
    • Ladenburg Thalmann 2019 Healthcare Conference on Tuesday, September 24 at the Sofitel New York

    Achieve logo (PRNewsfoto/Achieve Life Sciences, Inc.)

     A live webcast can be accessed at http://ir.achievelifesciences.com/events-and-webcasts. A replay of the presentations will be archived on Achieve's website following the conferences. 

    About Achieve
    Tobacco use is currently the leading cause of preventable death and is responsible for nearly seven million deaths annually worldwide1. It is estimated that 28.7% of cancer deaths in the U.S. are attributable to cigarette smoking2.

    Achieve's focus is to address the global smoking health epidemic through the development and commercialization of cytisinicline. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

    As an approved, branded product in Central and Eastern Europe for more than two decades, it is estimated that over 20 million people have used cytisinicline to help combat nicotine addiction.

    Achieve Contact
    Jason Wong
     
    (415) 375-3340 ext. 4

    1  World Health Organization. WHO Report on the Global Tobacco Epidemic, 2017. Geneva: World Health Organization, 2017
    2 Annals of Epidemiology , Volume 25 , Issue 3 , 179 - 182.e1

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-announces-presentations-at-upcoming-investor-conferences-300910961.html

    SOURCE Achieve Life Sciences, Inc.

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