ACHV BALANCE LLC

Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024SEATTLE and VANCOUVER, British Columbia, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced its financial results for the second quarter of 2024 and provided an update on its cytisinicline development program. Recent Highlights The FDA granted Breakthrough Therapy designation for cytisinicline treatment of nicotine e-cigarette, or vaping, cessationCompleted refinancing and extended the maturity date of outstanding term loans with Silicon Valley Bank (SVB)Joined the U.S. Russell 3000® and Russell Microcap® IndexesInitiated ORCA-OL clinical trial evaluating long-term exposure of cytisinicline in people who smoke or use nicotine e-cigarettesPresented data from cytisinicline ORCA-V1 program at Society of General Internal Medicine (SGIM) Annual Meeting “We are extremely proud of the significant milestones we have accomplished over the last few months, including the granting of Breakthrough Therapy designation for cytisinicline for vaping cessation, which highlights the urgent need for an effective treatment to help the millions of people who are battling nicotine vape addiction,” stated John Bencich, Chief Executive Officer of Achieve. “Additionally, we initiated and are making great progress in the ORCA-OL trial evaluating long-term cytisinicline exposure moving us closer to our expected NDA filing in the first half of 2025.” Cytisinicline for Vaping Cessation Granted FDA Breakthrough Therapy DesignationThe U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. The designation aims to accelerate the development and review process for promising drugs that are intended to treat serious conditions and when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. There are currently no FDA-approved treatments specifically indicated for vaping cessation. Achieve plans to hold an End-of-Phase 2 meeting with the FDA’s multidisciplinary team under this Breakthrough Therapy designation before the end of the year. Refinanced Outstanding Loan with Silicon Valley BankAchieve announced that it has entered into a debt refinancing agreement of up to $20 million with SVB, a division of First-Citizens Bank & Trust Company (FCB). The new loan agreement refinances the existing debt facility with SVB and extends the maturity date from August 1, 2024 to December 1, 2027. Achieve’s obligations under the prior agreement were satisfied in full, and the previous agreement was terminated in connection with the new contingent convertible debt agreement. Joined Russell 3000® and Russell Microcap® IndexesAchieve received its inclusion in the U.S. Russell 3000® and Russell Microcap® Indexes, which became effective July 1, 2024. This inclusion enhances the company's visibility among investors, reflecting Achieve’s strong business fundamentals and market potential for cytisinicline as a treatment for nicotine dependence. Initiated ORCA-OL TrialThe open-label, ORCA-OL trial, was initiated in May 2024 and will incorporate participants from earlier cytisinicline clinical trials to efficiently compile safety data over extended periods, specifically focused on subjects treated with cytisinicline for up to one year. Enrollment is ongoing at 29 clinical trial sites in the U.S. with more than half of the proposed 650 participants already enrolled on the study. The necessary clinical data from ORCA-OL is anticipated to be available to support an NDA submission in the first half of 2025. ORCA-V1 Data Presented at the SGIM Annual MeetingData from the Phase 2 ORCA-V1 vaping cessation trial were presented at the SGIM Annual Meeting. The findings showed that cytisinicline more than doubled the likelihood of quitting nicotine e-cigarettes compared to placebo. Cytisinicline has shown promise in aiding smoking cessation and may also help individuals quit vaping. Financial ResultsAs of June 30, 2024, the company’s cash, cash equivalents, restricted cash and short-term investments total $61.3 million. Total operating expenses for the three and six months ended June 30, 2024 were $8.4 million and $14.4 million, respectively. The total net loss for the three and six months ended June 30, 2024 was $8.5 million and $15.0 million, respectively. As of August 13, 2024, Achieve had 34,341,303 shares outstanding. Conference Call DetailsAchieve will host a conference call at 4:30 PM EDT today, Tuesday, August 13, 2024. To access the webcast, log on to the investor relations page of the Achieve website and use the following link: 2Q24 Earnings Webcast. Alternatively, access to the live conference call is available by dialing (877) 269-7756 (U.S. & Canada) or (201) 689-7817 (International) and referencing conference ID 13747337. 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 Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are approximately 29 million adults in the United States alone who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 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.3 In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2023, approximately 2.1 million middle and high school students in the United States reported using e-cigarettes.5 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com. Forward Looking StatementsThis 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 regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of, risks related to the impact of macroeconomic and geopolitical environment, including inflation, increased volatility in interest rates and the debt and equity markets, instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. Investor Relations ContactNicole Jonesachv@cg.capital(404) 736-3838 Media ContactGlenn SilverGlenn.Silver@Finnpartners.com(646) 871-8485 References1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641.2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.5Birdsey J, Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1173–1182. Consolidated Statements of Loss(In thousands, except per share and share data) Three months ended June 30, Six months ended June 30, 2024 2023 2024 2023 Operating expenses: Research and development 5,113 4,585 7,912 10,119 General and administrative 3,318 3,129 6,501 6,173 Total operating expenses 8,431 7,714 14,413 16,292 Loss from operations (8,431) (7,714) (14,413) (16,292)Other income (expense) (30) (525) (542) (939)Net loss$(8,461) $(8,239) $(14,955) $(17,231) Basic and diluted net loss per share$(0.25) $(0.43) $(0.50) $(0.93) Weighted average number of basic and diluted common shares 34,318,709 19,048,627 29,683,422 18,486,322 Consolidated Balance Sheets(In thousands) June 30, December 31, 2024 2023 Assets: Cash, cash equivalents and short-term investments $61,313 $15,546 Prepaid expenses and other current assets 1,206 1,436 Other assets and restricted cash 117 92 Right-of-use assets 35 66 License agreement 1,086 1,197 Goodwill 1,034 1,034 Total assets $64,791 $19,371 Liabilities and stockholders' equity: Accounts payable and accrued liabilities $4,861 $4,088 Current portion of long-term obligations 37 63 Current portion of convertible debt 8,804 16,662 Non-current portion of convertible debt 8,804 — Long-term obligations — 6 Stockholders' equity 42,285 (1,448)Total liabilities and stockholders' equity $64,791 $19,371

Company to host conference call at 4:30 PM EDT today, Thursday, May 9, 2024SEATTLE and VANCOUVER, British Columbia, May 09, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced its financial results for the first quarter of 2024 and provided an update on the cytisinicline development program. Recent Highlights Published Phase 2 ORCA-V1 clinical trial results in the Journal of the American Medical Association Internal Medicine (JAMA IM)Advanced plans for the initiation of the long-term cytisinicline exposure trial (ORCA-OL)Presented data from Phase 3 ORCA-2 and ORCA-3 trials, and Phase 2 ORCA-V1 trial at the Society for Research on Nicotine and Tobacco (SRNT) Annual MeetingAnnounced an equity financing totaling up to $124.2 million that included initial upfront gross proceeds of $60.0 million and up to an additional approximately $64.2 million of gross proceeds upon exercise of milestone-driven warrants “It has been a busy and exciting first quarter of 2024. Our focus has been to ensure adequate resources and execution of activities required for the cytisinicline NDA submission in the United States. We are pleased with the progress we’ve made on preparations for the ORCA-OL trial, which we expect to initiate in the coming weeks,” stated John Bencich, Chief Executive Officer of Achieve. “We are also pleased to once again this quarter have our trial results presented and published in highly esteemed medical forums, demonstrating the quality and standard of excellence of our clinical development program.” ORCA-V1 Results Published in JAMA Internal MedicineThe positive Phase 2 ORCA-V1 trial results for cytisinicline as a treatment for vaping cessation were published in JAMA IM. Cytisinicline treatment more than doubled the odds of achieving abstinence and was well tolerated. Achieve expects to conduct an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in 2024 to discuss future plans for an expanded label in e-cigarette cessation. ORCA-OL on Target to Initiate Enrollment in May 2024 Achieve and the FDA reached agreement that a single, open-label study evaluating for long-term safety exposure of cytisinicline will be sufficient to enable a New Drug Application (NDA) submission, now anticipated in the first half of 2025. The open-label trial, ORCA-OL, is on target to initiate in May 2024 and will recruit from the over 1,700 participants from earlier trials to efficiently generate longer-term safety data of cytisinicline treatment for up to one year. Clinical Data Presented at Annual Society for Research on Nicotine and Tobacco ConferenceAchieve presented three cytisinicline clinical data abstracts during the Annual SRNT conference. These included Phase 3 trials ORCA-2 and ORCA-3, and the Phase 2 trial ORCA-V1. In addition to the trial results, for the first time, survey results from Phase 3 participants revealed that 69% of those who received cytisinicline experienced success in quitting smoking and 22% experienced a significant reduction in smoking. Participants attributed their success to cytisinicline, citing reduced cravings and manageable side effects. Almost all participants expressed willingness to recommend cytisinicline to others. ORCA-3 confirmed higher quit rates with cytisinicline compared to placebo, without an increased relapse risk. Additionally, ORCA-V1 demonstrated cytisinicline's potential for vaping cessation, with significantly increased quit rates and minimal side effects among e-cigarette users. Registered Direct Offering and Concurrent Private PlacementIn February 2024, Achieve entered into a securities purchase agreement with new and existing investors to raise up to approximately $124.2 million in gross proceeds that included initial upfront funding of $60.0 million and up to an additional approximately $64.2 million upon exercise of milestone-driven warrants. The proceeds support the ongoing clinical development of cytisinicline through NDA submission, including the ORCA-OL trial, to fund other cytisinicline-related research and clinical development activities and for working capital and general corporate purposes. Achieve expects proceeds from the registered direct offering and concurrent private placement, assuming the exercise of all of the milestone-driven warrants, plus existing cash, will be sufficient to fund its development of cytisinicline into 2026 and through potential FDA approval. Financial ResultsAs of March 31, 2024, Achieve’s cash, cash equivalents, and restricted cash totaled $66.4 million, reflecting the closing of the registered direct offering and concurrent private placement, which resulted in gross proceeds of $60.0 million prior to deducting placement agent fees and offering expenses. Total operating expenses for the first quarter ended March 31, 2024 were $6.0 million. The total net loss for the first quarter ended March 31, 2024 was $6.5 million. As of May 9, 2024, Achieve had 34,341,303 shares outstanding. Conference Call DetailsAchieve will host a conference call at 4:30 PM EDT today, Thursday, May 9, 2024. To access the webcast, log on to the investor relations page of the Achieve website and use the following link: 1Q24 Earnings Webcast. Alternatively, access to the live conference call is available by dialing (877) 269-7756 (U.S. & Canada) or (201) 689-7817 (International) and referencing conference ID 13744142. 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 CytisiniclineAchieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are an estimated 28 million adults in the United States alone who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 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.3 In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.1 In 2023, approximately 2.1 million middle and high school students in the United States reported using e-cigarettes.4 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com. Forward Looking StatementsThis 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 regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact of macroeconomic and geopolitical environment, including inflation, increased volatility in interest rates and the debt and equity markets, instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. Investor Relations ContactNicole Jonesachv@cg.capital(404) 736-3838 Media ContactGlenn SilverGlenn.Silver@Finnpartners.com(646) 871-8485 References1Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.4Birdsey J, Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1173–1182. Consolidated Statements of Loss(In thousands, except per share and share data) Three months ended March 31, 2024 2023 Operating expenses: Research and development 2,799 5,534 General and administrative 3,183 3,044 Total operating expenses 5,982 8,578 Loss from operations (5,982) (8,578)Other income (expense) (512) (414)Net loss$(6,494) $(8,992) Basic and diluted net loss per share$(0.26) $(0.50) Weighted average number of basic and diluted common shares 25,048,134 17,917,769 Consolidated Balance Sheets(In thousands) March 31, December 31, 2024 2023 Assets: Cash and cash equivalents$66,398 $15,546 Prepaid expenses and other current assets 1,311 1,436 Other assets and restricted cash 94 92 Right-of-use assets 51 66 License agreement 1,141 1,197 Goodwill 1,034 1,034 Total assets$70,029 $19,371 Liabilities and stockholders' equity: Accounts payable and accrued liabilities$3,379 $4,088 Current portion of long-term obligations 53 63 Convertible debt 17,141 16,662 Long-term obligations — 6 Stockholders' equity 49,456 (1,448)Total liabilities and stockholders' equity$70,029 $19,371

Company to host conference call at 4:30 PM EDT today, Thursday, March 28, 2024SEATTLE and VANCOUVER, British Columbia, March 28, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced fourth quarter and year-end 2023 financial results and provided an update on the cytisinicline development program. Recent Highlights Announced Company reached agreement with the U.S. Food and Drug Administration (FDA) on long-term cytisinicline exposure requirements to support a New Drug Application (NDA) submissionCompleted an equity financing of up to $124.2 million that included initial upfront gross proceeds of $60.0 million, prior to deducting placement agent fees and estimated offering expenses, and up to an additional approximately $64.2 million of gross proceeds upon exercise of milestone-driven warrantsPresented data from Phase 3 ORCA-2 and ORCA-3 trials, and Phase 2 ORCA-V1 trial at Society for Research on Nicotine and Tobacco (SRNT) John Bencich, Achieve’s Chief Executive Officer, commented, “2023 marked a significant turning point for Achieve as we accomplished several key milestones, such as repeating successful efficacy and safety outcomes in the second Phase 3 ORCA-3 trial for smoking cessation, positive data from the Phase 2 ORCA-V1 trial for vaping, and significant progress in our discussions with the FDA to further our goal of bringing cytisinicline forward to aid the millions of individuals who are seeking treatment for nicotine dependence. We are appreciative of the strong support and confidence from our stakeholders, including new investors who participated in the recent financing and smoking cessation opinion leaders who share in our enthusiasm for cytisinicline’s potential.” FDA Agreement on NDA Submission Requirement Achieve and the FDA have reached agreement that a single, open-label study evaluating for long-term safety exposure of cytisinicline will be sufficient to complete the requirement and enable an NDA submission anticipated in the first half of 2025. Achieve plans to initiate the “ORCA-OL” open-label exposure trial in the second quarter of 2024, which will include investigators and sites who have participated in the ORCA clinical trial program (ORCA-2, ORCA-3, and ORCA-V1 studies). Completed Registered Direct Offering and Concurrent Private Placement The Company completed an equity financing of up to $124.2 million that included initial upfront gross proceeds of $60.0 million, prior to deducting placement agent fees and estimated offering expenses, and up to an additional approximately $64.2 million gross proceeds upon exercise of milestone-driven warrants. Achieve expects proceeds from the registered direct offering and concurrent private placement, assuming the exercise of all of the milestone-driven warrants, will be sufficient to fund its development of cytisinicline into 2026 and through potential FDA approval. ORCA-2, ORCA-3 and ORCA-V1 Data Presented at Annual SRNT ConferenceDuring the Annual Society for Research on Nicotine and Tobacco conference in March, the Company had three cytisinicline clinical data abstracts selected for podium presentation. The selected abstracts covered data from the Phase 3 ORCA-2 and ORCA-3 trials, alongside the Phase 2 ORCA-V1 trial, and presented compelling evidence on the potential efficacy and safety of cytisinicline for smoking and vaping cessation. Results presented from the Phase 3 participant surveys, showed that 69% of survey respondents who received cytisinicline reported quitting smoking completely. For those on treatment that did not achieve full smoking abstinence, 22% reported a reduction of their smoking by over half. Nearly all participants who quit smoking attributed their success to cytisinicline and cited fewer cravings and tolerable side effects as the main reasons. Additionally, 97% reported they would recommend cytisinicline to others. The ORCA-3 trial further validated these survey results, demonstrating higher smoking abstinence rates with cytisinicline compared to placebo, without increased relapse risk after transitioning to placebo. Furthermore, the ORCA-V1 trial explored cytisinicline's potential in vaping cessation among 160 e-cigarette users, showing a significant increase in abstinence rates compared to placebo, with minimal side effects. Financial ResultsAs of December 31, 2023, the Company’s cash, cash equivalents, and restricted cash was $15.6 million. After giving effect to the February 2024 equity financing the Company’s pro forma cash, cash equivalents, and restricted cash as of December 31, 2023, would have been $71.8 million. Total operating expenses for the fourth quarter and year ended December 31, 2023 were $4.4 million and $27.3 million, respectively. Total net loss for the fourth quarter and year ended December 31, 2023 was $5.5 million and $29.8 million, respectively. As of March 28, 2024, Achieve had 34,251,911 shares outstanding. Conference Call DetailsAchieve will host a conference call at 4:30 PM EDT Thursday, March 28, 2024. To access the webcast, log on to the investor relations page of the Achieve website and use the following link 4Q23 Earnings Webcast. Alternatively, access to the live conference call is available by dialing (877) 269-7756 (U.S. & Canada) or (201) 689-7817 (International) and referencing conference ID 13744140. 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 Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are an estimated 28 million adults in the United States alone who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 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.3 In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.3  In 2023, approximately 2.1 million middle and high school students in the United States reported using e-cigarettes.4 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation.  Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com. Forward Looking StatementsThis 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 regulatory review and approval, data results and commercialization activities, the anticipated proceeds from outstanding milestone-driven warrants, the sufficiency of Achieve’s capital resources to fund the development of cytisinicline through potential FDA approval, the the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic conditions, including inflation, rising interest rates, instability in the global banking sector, and public health crises, such as 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. Investor Relations ContactNicole Jonesachv@cg.capital(404) 736-3838 Media ContactGlenn SilverGlenn.Silver@Finnpartners.com(646) 871-8485 References1Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483.2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.4Birdsey J, Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle and High School Students — National Youth Tobacco Survey, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1173–1182. Consolidated Statements of Loss(In thousands, except per share and share data) Three months ended December 31, Twelve months ended December 31, 2023 2022 2023 2022 Operating expenses: Research and development 2,114 8,614 15,814 30,078 General and administrative 2,272 2,248 11,436 10,722 Total operating expenses 4,386 10,862 27,250 40,800 Loss from operations (4,386) (10,862) (27,250) (40,800)Other income (expense) (1,090) (370) (2,565) (1,550)Net loss$(5,476) $(11,232) $(29,815) $(42,350) Basic and diluted net loss per share$(0.26) $(0.83) $(1.50) $(4.00) Weighted average number of basic and diluted common shares 21,165,760 13,536,944 19,827,354 10,593,034 Consolidated Balance Sheets(In thousands) December 31, December 31, 2023 2022 Assets: Cash and cash equivalents $15,546 $24,771 Prepaid expenses and other current assets 1,436 2,559 Other assets and restricted cash 92 66 Right-of-use assets 66 123 License agreement 1,197 1,418 Goodwill 1,034 1,034 Total assets $19,371 $29,971 Liabilities and stockholders' equity: Accounts payable and accrued liabilities $4,088 $5,470 Current portion of long-term obligations 63 58 Convertible debt 16,662 16,071 Long-term obligations 6 69 Stockholders' equity (1,448) 8,303 Total liabilities and stockholders' equity $19,371 $29,971