Sopharma AD

$60 million financing upfront with up to an additional $64.2 million tied to exercise of milestone-driven warrants Upfront net proceeds to provide funds to conduct clinical development of cytisinicline through New Drug Application submission expected in 1H 2025, including the ORCA-OL trial Aggregate net proceeds (assuming exercise of all milestone-driven warrants) expected to be sufficient to fund cytisinicline development through potential FDA approval SEATTLE, Wash. and VANCOUVER, British Columbia, Feb. 29, 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 that it has entered into a securities purchase agreement with new and existing investors to raise up to approximately $124.2 million in gross proceeds that includes initial upfront funding of $60.0 million and up to an additional approximately $64.2 million upon exercise of milestone-driven warrants. The financing includes participation from healthcare-dedicated investors, including Propel Bio Partners LLC, Nantahala Capital, and a large, life sciences-dedicated investor. The financing also includes participation from strategic investor Sopharma and certain members of the company’s management team and board of directors. Lake Street Capital Markets, LLC and JonesTrading Institutional Services LLC are acting as joint placement agents for the registered direct offering and concurrent private placement. The purchase and sale will be completed, in part, via a registered direct offering of 13,086,151 shares of common stock at a price of $4.585 per share. In a concurrent private placement, the company will issue unregistered warrants to purchase up to 13,086,151 shares of common stock at an exercise price of $4.906 per share (provided, however, that the purchaser may elect to exercise the warrants for pre-funded warrants in lieu of shares of common stock at an exercise price of $4.906, minus $0.001, the exercise price of each pre-funded warrant). These warrants will be immediately exercisable for shares of common stock or pre-funded warrants in lieu thereof, and will expire on the earlier of (i) three and one-half years following the date of issuance and (ii) 30 days following Achieve’s public disclosure of the acceptance of a New Drug Application (NDA) for cytisinicline by the U.S. Food and Drug Administration (FDA) in a Day 74 Letter or equivalent correspondence. The registered direct offering and the concurrent private placement are each expected to close on or about March 4, 2024, subject to customary closing conditions. The aggregate gross proceeds from the issuance of common stock in the registered direct offering are expected to be approximately $60.0 million, prior to deducting placement agent fees and estimated offering expenses. The company intends to use the proceeds from the offering to fund clinical development of cytisinicline through NDA submission, expected in 1H 2025, including the ORCA-OL clinical trial, to fund other cytisinicline related research and clinical development activities and for working capital and general corporate purposes. If the milestone-driven warrants issued in the private placement are exercised in full, the company would receive $64.2 million in additional proceeds. The company expects that the net 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. The shares of common stock are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-261811), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on January 5, 2022. The milestone-driven warrants being issued in the private placement, along with the securities underlying such milestone-driven warrants, are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the milestone-driven warrants and underlying securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Achieve, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. A prospectus supplement relating to the registered shares of common stock will be filed by the company with the SEC. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at or from Lake Street Capital Markets, LLC, Prospectus Department, 920 Second Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email at info@lakestreetcm.com or JonesTrading Institutional Services LLC, Attention: Equity Capital Markets, 325 Hudson Street, 6th Floor New York, New York 10013; email: ecm@jonestrading.com. 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. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the completion of the offering, the expected net proceeds of the offering, the expected net proceeds upon exercise of the warrants, the intended use of the proceeds of the offering and the expected sufficiency of such proceeds to fund the development of cytisinicline through potential FDA approval. 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, risks regarding Achieve’s ability to satisfy closing conditions related to the offering; risks related to market conditions; 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 Achieve’s 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 law. Investor Relations Contact  Nicole Jones achv@cg.capital (404) 736-3838 Media Contact Glenn Silver Glenn.Silver@Finnpartners.com (646) 871-8485 References 1Cornelius 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.

Company to host conference call at 4:30 PM EST today, November 14, 2022SEATTLE and VANCOUVER, British Columbia, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced third quarter 2022 financial results and provided an update on the cytisinicline development program. Highlights Completion of targeted enrollment in Phase 3 ORCA-3 clinical trial of cytisinicline in 750 adult smokers was announced in SeptemberEarly completion of targeted enrollment in the Phase 2 ORCA-V1 clinical trial of cytisinicline in 150 adult nicotine e-cigarette users was announced in NovemberNew active pharmaceutical ingredient (API) suite construction completed by Sopharma, expanding the global commercial manufacturing capacity for cytisinicline “Completing enrollment in the ORCA-3 trial this quarter and more recently, the ORCA-V1 trial, has moved us closer to potentially bringing a critical treatment option to people who wish to end their nicotine dependence,” stated John Bencich, CEO of Achieve Life Sciences. “We are excited to build upon the previously reported cessation benefit, safety, and tolerability of cytisinicline and look forward to releasing top-line data for both trials in the second quarter of next year.” Completed Enrollment in Confirmatory Phase 3 ORCA-3 TrialIn September, Achieve announced the completion of targeted enrollment of 750 adult smokers in its confirmatory Phase 3 ORCA-3 clinical trial of cytisinicline being conducted across 20 clinical trial locations in the United States. The participants in ORCA-3 were randomized to one-of-three study arms to determine the efficacy and safety of cytisinicline administered for either 6 or 12 weeks, compared to placebo. Similar to the previously reported ORCA-2 trial, the primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment in the 6 and 12-week cytisinicline treatment arms compared to placebo. Each treatment arm will be compared independently to the placebo arm and the trial will be determined to be successful if either or both of the cytisinicline treatment arms show a statistical benefit compared to placebo. Topline ORCA-3 data are currently expected to be reported in Q2 of 2023. Early Completion of Enrollment in Phase 2 ORCA-V1 TrialIn November, Achieve announced the early completion of targeted enrollment of 150 adult users of nicotine e-cigarettes in the Phase 2 ORCA-V1 clinical trial of cytisinicline being conducted across 5 clinical trial locations in the United States. Participants were randomized in this two-arm trial to receive either cytisinicline, dosed at 3 mg three times daily, or placebo, for a period of 12 weeks. All subjects are also receiving standardized behavioral support throughout the trial. The primary outcome assessment of ORCA-V1 will be continuous vaping abstinence during the final 4 weeks of treatment. ORCA-V1 is supported through grant funding from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH). Topline results are expected to be reported in Q2 of 2023. Sopharma Expansion of Manufacturing Facility Achieve’s commercial manufacturing partner, Sopharma, financed and completed the build out of a new dedicated cytisinicline API purification suite at its primary manufacturing plant. At an estimated build out cost of more than €3 million, the newly completed API suite significantly expands the capacity to produce quantities of cytisinicline at a global scale. The new API suite complements Sopharma’s capacity to produce nearly 3 billion tablets annually. Financial Results As of September 30, 2022, the company’s cash, cash equivalents, and restricted cash were $18.2 million. Total operating expenses for the three and nine months ended September 30, 2022 were $12.6 million and $29.9 million, respectively. Total net loss for the three and nine months ended September 30, 2022 was $13.1 million and $31.1 million, respectively. As of November 10, 2022, Achieve had 9,710,747 shares of common stock outstanding. Conference Call DetailsAchieve will host a conference call today at 4:30 PM EST, Monday, November 14, 2022. To access the webcast, please use the following link 3Q22 Earnings Webcast. Alternatively, you may access the live conference call by dialing (877) 269-7756 (Domestic) or (201) 689-7817 (International) and referencing conference ID 13733008. A webcast replay will be available approximately three 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. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2 In addition, there are nearly 11 million adults in the United States who use e-cigarettes, also known as vaping.3 While nicotine e-cigarettes are thought to be less harmful than combustible cigarettes, they remain addictive and can deliver harmful chemicals which can cause lung injury or cardiovascular disease.4 In 2021, e-cigarettes were the most commonly used tobacco product reported by 1.72 million high school students.5 Research shows adolescents who have used e-cigarettes are seven times more likely to become smokers one year later compared to those who have never vaped.6 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com. 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, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of the COVID-19 pandemic or similar public health crises and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. Investor Relations ContactRich Cockrellachv@cg.capital (404) 736-3838 Media ContactGlenn SilverGlenn.Silver@Finnpartners.com (646) 871-8485 References1World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017.2U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.3Cornelius ME, Wang TW, Jamal A, Loretan CG, Neff LJ. Tobacco Product Use Among Adults — United States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:1736–1742. DOI: 10.15585/mmwr.mm6946a44Ogunwale, Mumiye A et al. (2017) Aldehyde Detection in Electronic Cigarette Aerosols. ACS omega 2(3): 1207-1214. DOI: 10.1021/acsomega.6b00489].5Gentzke AS, Wang TW, Cornelius M, et al. Tobacco Product Use and Associated Factors Among Middle and High School Students – National Youth Tobacco Survey, United States, 2021. MMWR Surveill Summ 2022;71(no. SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1.6Elizabeth C. Hair, Alexis A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao, Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association between e-cigarette use and future combustible cigarette use: Evidence from a prospective cohort of youth and young adults, 2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN 0306-4603. DOI: 10.1016/j.addbeh.2020.106593. Consolidated Statements of Loss(In thousands, except per share and share data) Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Operating expenses: Research and development 9,869 4,591 21,464 19,460 General and administrative 2,770 2,102 8,474 6,519 Total operating expenses 12,639 6,693 29,938 25,979 Loss from operations (12,639) (6,693) (29,938) (25,979)Other income (expense) (438) 2 (1,180) (22)Net loss $(13,077) $(6,691) $(31,118) $(26,001) Basic and diluted net loss per share $(1.35) $(0.71) $(3.24) $(3.39) Weighted average number of basic and diluted common shares 9,693,788 9,452,238 9,600,947 7,670,383 Consolidated Balance Sheets(In thousands) September 30, December 31, 2022 2021 Assets: Cash and cash equivalents $18,197 $43,022Prepaid expenses and other current assets 2,760 1,572Other assets and restricted cash 239 183Right-of-use assets 18 64License agreement 1,475 1,641Goodwill 1,034 1,034Total assets $23,723 $47,516 Liabilities and stockholders' equity: Accounts payable and accrued liabilities $6,893 $4,481Current portion of long-term obligations 23 69Convertible debt 15,763 14,920Long-term obligations — 4Stockholders' equity 1,044 28,042Total liabilities and stockholders' equity $23,723 $47,516

Dialysis concentrates are prepared according to the patient’s requirement and help in regulating their acid-base and electrolyte balance and removing metabolic waste products from the blood. Automated dialysis concentrated production systems are used to produce these concentrates. The production in the automated dialysis concentrated production systems include bicarbonate concentrate production, acid concentrate production, and specific modifiers for hemodialysis. Automated dialysis concentrated production systems have storage tanks and mixing tanks where the dialysis concentrates are prepared. The storage tanks in an automated dialysis concentrated production system are connected to the delivery systems for dialysis centers. For more insights into the Market, Request a Sample of this Report - What are New Trends Emerging in Global Market? Automated dialysis concentrated production systems market is highly driven by hemodialysis. Hemodialysis is one of the most common dialysis methods performed for patients suffering from chronic kidney diseases and related ailments. According to the National Center for Chronic Disease Prevention and Health Promotion, there were approximately 118,000 people in the US in 2014 who started the treatment for ESRD and 662,000 were on chronic dialysis or had a kidney transplant. Open automated dialysis concentrated production system is expected to grow at the fastest rate owing to a better and improved validation of the dialysis fluid and water treatment and production of fluid according to the required quality. Automated dialysis concentrated production systems market is highly driven by growing incidences of chronic kidney diseases and kidney-related ailments. Increase in private investment and venture funding as support to the manufacturing of more advanced production systems is also expected to drive the automated dialysis concentrated production systems market over the forecast period. Government spending on health care, especially for patients dealing with chronic kidney diseases has been improving and could drive the demand for automated dialysis concentrated production systems over the forecast period. However, there is low awareness about kidney-related ailments which might hinder market growth for automated dialysis concentrated production systems. The procedure is also costly, making it highly unaffordable for middle-income and poor-economy countries. This could also hinder the automated dialysis concentrated production systems market over the forecast period. View Detailed Table of Content Here: How Will North America Continue Dominating Global Market in Future? A vital factor which is driving the North America market for automated dialysis concentrated production systems is the growing awareness about the availability of automated dialysis concentrated production systems for treatment of various kidney diseases and kidney related ailments. North America’s automated dialysis concentrated production systems market is also expected to grow at a faster rate owing to good healthcare spending and healthcare infrastructure. Europe is one of the leading regions for automated dialysis concentrated production systems market because of the high incidence and prevalence of kidney diseases and consistent rise in geriatric population. Lack of awareness about kidney diseases and dialysis will hinder the Asia-Pacific’s market for automated dialysis concentrated production systems over the forecast period. The major market participants operating in the global automated dialysis concentrated production systems market are B. Braun Melsungen AG, REN MED MEDICAL PRODUCTS & TRADE LTD. CO., Nipro Renal Solutions, Unipharm JSC, and FLG Automation AG. Request Methodology on this Research Report for specific research solutions: Explore Fact.MR’s Lucid Healthcare Coverage Drug Discovery Services Market – Increase in the research and development activities and expenditure, leading pharmaceutical companies moving towards outsourcing are some of the factors resulting in the growth of drug discovery services. Introduction of advanced technology in the drug discovery process is also the major driver in the market growth. Preimplantation Genetic Testing Market – The preimplantation genetic testing market is likely to be influenced by a combination of macroeconomic and microeconomic factors. Due to the changing lifestyle, increasing number of people are suffering from genetic disorders or diseases. Hence there has been a significant demand growth in preimplantation genetic testing. 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