ACHV Achieve Life Sciences Inc.

10.23
-0.74  -7%
Previous Close 10.97
Open 13.12
52 Week Low 4.51488
52 Week High 48.6
Market Cap $36,697,107
Shares 3,587,205
Float 2,737,377
Enterprise Value $24,861,107
Volume 1,813,174
Av. Daily Volume 699,727
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Drug Pipeline

Drug Stage Notes
Cytisine - ORCA-2
Smoking cessation
Phase 3
Phase 3
Phase 3 trial to be initiated 2H 2020.

Latest News

  1. 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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  2. 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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  3. 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

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/achieve-life-sciences-announces-presentation-of-cytisinicline-data-at-the-20th-annual-society-for-research-on-nicotine--tobacco-europe-srnt-e-virtual-conference-301127075.html

    SOURCE Achieve Life Sciences, Inc.

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  4. 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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  5. 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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