Nicotine

Richard Stewart reassumes role of Chief Executive Officer Thomas King appointed Executive Chairman of the Board of Directors SEATTLE and VANCOUVER, British Columbia, Aug. 26, 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 that Mr. Richard (Rick) Stewart, Achieve’s co-founder and current Executive Chairman, will reassume the role of Chief Executive Officer. John Bencich, who served as the Company’s Chief Executive Officer for the past four years, will serve as an advisor during the transition. Additionally, the Company announced that Mr. Thomas (Tom) King, currently the lead independent director of the Board of Directors, will assume the role of Executive Chairman. “The change in leadership is driven by the need to have a CEO with substantial M&A and commercial experience pushing the company forward to future critical milestones, whether that be a potential licensing transaction or strategic transaction for the commercialization of cytisinicline,” commented Tom King, Executive Chairman of Achieve’s Board of Directors. “On behalf of Achieve, we thank John for his tenure with the Company and appreciate his assistance during this transition.” “It’s been an incredible journey helping Achieve grow over the past seven years and I wish the new leadership team continued success as they drive the cytisinicline program forward to patients,” commented John Bencich. “I am thankful for the time I had at Achieve and all we accomplished, and am looking forward to pursuing my next opportunity.” Rick Stewart, Achieve Chief Executive Officer, added, “We remain on track to meet our objectives for this year, including the completion of enrollment of the ORCA-OL study, meeting with the FDA for our End-of-Phase 2 meeting for vaping cessation under Breakthrough Therapy designation, and furthering our progress on the NDA submission, that we expect to file in the first-half of 2025. I look forward to my new role and leading our excellent team to bring forward a potentially life-changing treatment for millions of people who battle nicotine dependence, while at the same time aiming to optimize shareholder value.” 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 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 entry into any licensing or other strategic transactions, 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, the development and effectiveness of new treatments, and the ability to drive shareholder value. 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 and geopolitical conditions, including inflation, rising interest rates, increased volatility in the debt and equity markets, actual or perceived 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 ContactRich Cockrellachv@cg.capital(404) 736-3838 Media ContactGlenn SilverGlenn.Silver@Finnpartners.com(646) 871-8485 References 1VanFrank 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.

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

THURSDAY, Aug. 8, 2024 -- That vape pen might contain something even worse than nicotine, new research warns. Tobacco companies may be trying to duck federal restrictions on vaping products by replacing nicotine with “nicotine analogs” -- related chemicals that have similar properties but unknown health effects, researchers report. “Vaping products containing nicotine are subject to federal laws that prohibit sales to people under the age of 21,” explained researcher Dr. Sairam Jabba , a toxicologist at Duke University School of Medicine, in Durham, N.C. “Nicotine analogs are currently not subject to the FDA process and have not been studied for their health effects.” “It’s possible manufacturers are attempting to avoid FDA tobacco regulation,” Jabba added in a Duke news release. A lab analysis of nicotine analog vapes sold in the United States also “found significant and concerning inaccuracies in the ingredients these products claim to contain and what they actually contain,” Jabba said. For example, a vaping brand called Spree Bar, which comes in at least nine flavors, is listed as containing 5% 6-methyl nicotine, researchers said. A nicotine analog, 6-methyl nicotine has been shown in rodent experiments to be far more potent in targeting the brain’s nicotine receptors, researchers noted. It’s also more toxic than nicotine. Analysis of the Spree Bar products found they contained 88% less 6-methyl nicotine than labeled. They also contained an artificial sweetener up to 13,000 times sweeter than table sugar and an artificial coolant that mimics menthol. Another analog called nicotinamide is being marketed as targeting the same brain receptors as nicotine, even though evidence has shown it doesn’t bind to those receptors, researchers said. E-cigarettes labeled as containing nicotinamide -- Nixotine, Nixodine, Nixamide and Nic-Safe -- had levels lower than their labels indicated, and were combined with undisclosed amounts of 6-methyl nicotine, researchers found. “These products appear to be designed to circumvent the laws and regulations in place to protect people -- especially children -- from the harmful effects of smoking and tobacco use,” said co-senior researcher Sven Eric Jordt , research project director with the Yale Tobacco Center of Regulatory Science. “We do not know what these chemicals do when they are heated and inhaled,” Jordt stressed. “These are questions that should be answered before we allow products on the market.” In late May, a coalition of anti-tobacco groups warned the U.S. Food and Drug Administration of at least three nicotine analog products being sold in the United States. Two of the products, Spree Bar and a snuff made by Outlaw Dip Co., argue on web sites and in promotional videos that their products are not subject to FDA regulation, their letter to FDA Commissioner Dr. Robert Califf noted. However, the promotional materials also promise the same sort of effects from nicotine analogs that people get from actual nicotine, the letter added. The letter quotes Spree Bar promotional materials as promising that the product “provides the same satisfaction, pleasure and enjoyment as traditional tobacco products and nicotine e-cigarettes.” The FDA letter was co-signed by the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Parents Against Vaping E-cigarettes and Truth Initiative. The research was published Aug. 7 in the Journal of the American Medical Association . Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.