Tobacco Use Disorder

Katie’s Way Provides Lifesaving Mental Health Treatment Nationally with a Focus on Servicemembers, Veterans, and their FamiliesBURLINGTON, Mass. and JERUSALEM, March 18, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, announced today that its significant existing partner, Katie's Way Plus, which provides comprehensive mental health services tailored to the unique needs of active duty military members, veterans, and their families, has ordered an additional 18 Deep Transcranial Magnetic Stimulation (Deep TMS™) systems. Katie’s Way Plus will now grow to an extensive network of approximately 40 Deep TMS systems. “We are delighted to continue supporting Katie's Way Plus in its pivotal mission of delivering specialized care to U.S. service members, veterans, and their families,” said Chris Boyer, BrainsWay’s Vice President of Marketing. “The efficacy demonstrated by BrainsWay's advanced Deep TMS technology in the treatment of depression is transformational. We are confident that the further expansion of this partnership will bring renewed hope and healing to countless families both in and out of uniform.” “The broadening of this important partnership reflects our continued success in attracting large enterprise customers nationwide,” said Hadar Levy, Chief Executive Officer of BrainsWay. “The synergistic alliance between BrainsWay and Katie's Way Plus is poised to meaningfully impact the landscape of mental health care for military personnel, ensuring access to cutting-edge solutions tailored to their unique needs.” “Katie's Way was established in memory of my daughter, Katie, whose tragic battle with depression serves as our driving force,” said Jeff Mathis, Founder of Katie’s Way. “Our aim is to prevent other families from enduring similar hardships. The acquisition of these additional BrainsWay systems is a testament to our rapidly expanding network and enables us to extend our reach, offer hope, and ultimately save more lives.” Since September 11, 2001, the prevalence of mental health conditions has risen drastically within the veteran community. Diagnosed cases of major depressive disorder have increased 32% since that time, and doctor visits for the condition now account for nearly 10% of all military health network appointments. The most well-known and publicized statistic among the military community is the high rate of suicide. In one study conducted across 27 states, it was found that the suicide rate among veterans is 50% higher than non-veterans1. About BrainsWayBrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com. About Katie’s WayKatie’s Way TMS is a trailblazing mental health care provider with a heartfelt commitment to improving the lives of active duty military service members, veterans, and their families. Founded by Jeff Mathis, our mission is deeply rooted in a profound personal loss. Jeff’s daughter, Katie, tragically lost her battle with depression, inspiring him to establish Katie’s Way with a resolute determination to prevent others from experiencing a similar tragedy. At Katie’s Way TMS, our focus is clear: to provide specialized care, hope, and healing to those who have selflessly served our nation. We understand the unique challenges that military members, veterans, and their families face when it comes to mental health, and we are dedicated to addressing these challenges head-on. With unwavering commitment, Katie’s Way TMS strives to make a meaningful impact by providing accessible, evidence-based care to individuals who have sacrificed so much for our country. Our journey is driven by the memory of Katie and the hope that no other family will have to endure the pain of losing a loved one to depression. Katie’s Way currently operates 5 treatment facilities in the United States, and plans to expand to up to 15 clinics this year. To learn more, please visit www.katieswayplus.com. Forward-Looking Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission. Contacts: BrainsWay: Ido Marom Chief Financial Officer 844-386-7001 ext. 5Ido.Marom@BrainsWay.com Investors: Brian RitchieLifeSci Advisors646-889-1200britchie@lifesciadvisors.com Media Contact:Chris Boyer844-386-7001 ext. 2Chris.Boyer@BrainsWay.com 1 https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/34283458/

Generated Record Revenues with Robust 50% Year-over-Year Revenue Growth in Q4 2023; Generated Positive Quarterly Net Income Providing Full-Year 2024 Revenue Guidance of $37-$40 Million with Continued Profitability Momentum and Cash Generation Conference Call to be Held Today at 8:30 AM ET BURLINGTON, Mass. and JERUSALEM, March 06, 2024 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a world leader in advanced and non-invasive treatment for brain disorders, today reported fourth quarter and full-year 2023 financial results and provided an operational update. Recent Financial and Operational Highlights For the three months ended December 31, 2023, revenues were $9.0 million, a 50% increase as compared to the fourth quarter of 2022, and a 9% increase over the third quarter of 2023.Gross margin for the fourth quarter of 2023 was 75%, an increase from 71% in the fourth quarter of 2022, and an increase from 74% in the third quarter of 2023.Operating income for the fourth quarter of 2023 was $0.2 million, compared to a loss of $4.3 million for the same period in 2022, and a loss of $0.1 million in the third quarter of 2023.Net income for the fourth quarter of 2023 was $0.1 million, compared to a net loss of $3.9 million for the fourth quarter of 2022, and a loss of $0.2 million for the third quarter of 2023.Adjusted EBITDA1 for the fourth quarter of 2023 was approximately $0.8 million, compared to a loss of $3.6 million for the fourth quarter of 2022, and positive Adjusted EBITDA1 of $0.3 million in the third quarter of 2023.Cash, cash equivalents, and short-term deposits as of December 31, 2023, amounted to $46.3 million, an increase of $2.0 million from September 30, 2023.The Company shipped a net total of 60 Deep TMS™ new systems during the fourth quarter of 2023, bringing BrainsWay’s total Deep TMS installed base to 1,101 total systems as of December 31, 2023, a 25% increase from the total installed base at the same point in the prior year.During the fourth quarter of 2023, the Company shipped 64 obsessive-compulsive disorder (OCD) coils as add-on helmets to certain of BrainsWay’s new and existing systems, representing OCD treatment capability on more than 50% of its total installed base.Increased collaboration with a growing mental health treatment provider based in the Western region of the U.S.; provider now has an installed base of seven Deep TMS systems.Expanded availability of Deep TMS in South Korea, with most recent delivery increasing installed base to 20 in this country.Continued to experience improved reimbursement trends. Private insurer in Louisiana covering 1.9 million lives recently went from four failed medication trials to two. Achieved significant progress in advancing the science of Deep TMS in various potential future applications. Published paper in Human Neuroscience highlighting the results from multiple trials on Deep TMS as a potentially novel therapeutic approach for Parkinson's Disease.Published paper in the Journal of Clinical Medicine highlighting Deep TMS for the potential treatment of late-life depression, including positive clinical data from a post-marketing study.Initiated clinical evaluation of BrainsWay’s exclusive, patented “Rotational Field” TMS, or Deep TMS 360°, stimulation technology in two new feasibility trials. One study will test the safety and efficacy of this technology in the field of rehabilitation following stroke, a devastating neurological condition.The second study will evaluate Deep TMS 360° in OCD utilizing an accelerated protocol. “Our annual 2023 revenues of $31.8 million represented an increase of 17% over full-year 2022, reflecting the strong and growing demand for our innovative Deep TMS technology,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “In the fourth quarter we generated positive net income, and for the second consecutive quarter, recorded positive Adjusted EBITDA1 and positive cash flow from operations.” “Based on our strong performance in 2023, and our belief that this trend will continue, we anticipate that our profitability momentum and positive cash generation will continue throughout this year. We expect that annual revenues in 2024 will be in the range of $37 to $40 million, representing growth of between 16% and 26% over 2023,” continued Mr. Levy. “Our robust sales pipeline, continued traction with large networks, international momentum and launch of several new studies aiming to further expand our total addressable market all continue to position BrainsWay as the leading innovative force in the TMS industry,” concluded Mr. Levy. Conference Call and Webcast BrainsWay’s management will host a conference call on Wednesday, March 6, 2024, at 8:30 a.m. Eastern Time to discuss these results and answer questions. Wednesday, March 6, 2024, at 8:30 AM Eastern Time: United States:877-407-3982International:201-493-6780Israel:1-809-406-247Conference ID:13744156Webcast:https://viavid.webcasts.com/starthere.jsp?ei=1654238&tp_key=7821acbb0b The conference call will be broadcast live and will be available for replay for 30 days on the Company’s website, https://investors.brainsway.com/events-and-presentations/event-calendar. Please access the Company’s website at least 10 minutes ahead of the conference call to register. _______________________ 1 See Adjusted EBITDA details and reconciliation table in the appendix below. Non-IFRS Financial MeasuresIn addition to our results determined in accordance with International Financial Reporting Standards (IFRS), including in particular operating income and net income, we believe that Adjusted EBITDA, a non-IFRS measure, is useful in evaluating our operating performance. We define Adjusted EBITDA as net income adjusted for depreciation and amortization, finance income, finance expenses, income taxes, cost of share-based payments, and one-time restructuring and litigation expenses. In addition to operating income (loss) and net income (loss), we use Adjusted EBITDA as a measure of operational efficiency. We believe that this non-IFRS financial measure is useful to investors for period-to-period comparisons of our business and in understanding and evaluating our operating results for the following reasons: Adjusted EBITDA is widely used by investors and securities analysts to measure a company’s operating performance without regard to items such as stock-based compensation expenses, depreciation and amortization, finance expenses, income taxes, and certain one-time items such as restructuring and litigation expenses, that can vary substantially from company to company depending upon their financing, capital structures and the method by which assets were acquired.Our management uses Adjusted EBITDA in conjunction with IFRS financial measures for planning purposes, including the preparation of our annual operating budget, as a measure of operating performance and the effectiveness of our business strategies and in communications with our board of directors concerning our financial performance; and Adjusted EBITDA provides consistency and comparability with our past financial performance, facilitates period-to-period comparisons of operations, and also facilitates comparisons with other peer companies, many of which use similar non-IFRS or non-GAAP financial measures to supplement their IFRS or GAAP results. Adjusted EBITDA, however, should not be considered as an alternative to operating income (loss) or net income (loss) for the period and may not be indicative of the historic operating results of the Company; nor is it meant to be predictive of potential future results. Adjusted EBITDA is not a measure of financial performance under IFRS and may not be comparable to other similarly titled measures for other companies. A reconciliation between the Company's net income (loss) and Adjusted EBITDA is presented in the attached summary financial statements. Because of these and other limitations, you should consider Adjusted EBITDA along with other IFRS-based financial performance measures, including net income (loss) and our IFRS financial results. About BrainsWayBrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit www.brainsway.com. Forward-Looking StatementThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that the FDA will clear additional indications or expand existing indications, or that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission. Contacts: BrainsWay:Ido MaromChief Financial Officer844-386-7001 ext. 5Ido.Marom@BrainsWay.com Investors:Brian RitchieLifeSci Advisors212-915-2578britchie@lifesciadvisors.com BRAINSWAY LTD. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF FINANCIAL POSITION U.S. dollars in thousands December 31, December 31, 2023 2022 ASSETS (Unaudited) (Audited) Current Assets Cash and cash equivalents $10,520 $47,581 Short-term deposits 35,465 - Restricted cash 271 271 Trade receivables, net 3,780 4,844 Inventory 3,717 3,837 Other current assets 1,712 1,556 55,465 58,089 Non-Current Assets System components 1,273 1,220 Leased systems, net 3,700 3,118 Other property and equipment 817 1,008 Other long-term assets 1,717 1,042 7,507 6,388 $62,972 $64,477 LIABILITIES AND EQUITY Current Liabilities Trade payables $758 $1,116 Deferred revenues 2,504 1,477 Liability in respect of research and development grants 1,008 1,057 Other accounts payable 5,491 4,491 9,761 8,141 Non-Current Liabilities Deferred revenues and other liabilities 5,553 4,923 Liability in respect of research and development grants 6,077 6,016 11,630 10,939 Equity Share capital 367 364 Share premium 140,344 138,146 Share-based payment reserve 4,360 6,180 Currency Translation Adjustments (2,188) (2,188) Accumulated deficit (101,302) (97,105) 41,581 45,397 $62,972 $64,477 BRAINSWAY LTD. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS U.S. dollars in thousands (except per share data) For the three months ended December 31, Year ended December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) (Audited) Revenues $9,029 $6,033 $31,785 $27,177 Cost of revenues 2,290 1,729 8,308 7,129 Gross profit 6,739 4,304 23,477 20,048 Research and development expenses, net 1,434 2,151 6,665 7,678 Selling and marketing expenses 3,959 4,750 16,456 18,199 General and administrative expenses 1,162 1,726 5,315 6,854 Total operating expenses 6,555 8,627 28,436 32,731 Operating profit (loss) 184 (4,323) (4,959) (12,683) Finance income (expense), net (221) 401 1,013 (351) Loss before income taxes (37) (3,922) (3,946) (13,034) Taxes on income (164) (55) 251 315 Net income (loss) and total comprehensive income (loss) $127 $(3,867) (4,197) (13,349) Basic and diluted net income (loss) per share $0.00 $(0.12) $(0.13) $(0.40) BRAINSWAY LTD. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS U.S. dollars in thousands For the three months ended December 31, For the year ended December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) (Audited) Cash flows from operating activities: Total comprehensive income (loss) $127 $(3,867) $(4,197) $(13,349) Adjustments to reconcile net loss to net cash used in operating activities: Adjustments to profit or loss items: Depreciation and amortization 83 101 362 558 Depreciation of leased systems 256 241 975 976 Impairments and disposals 509 400 1,447 816 Finance expenses, net 221 (401) (1,013) 351 Cost of share based payment 234 353 381 1,474 Income taxes (164) (55) 251 315 Total adjustments to reconcile loss 1,139 639 2,403 4,490 Changes in asset and liability items: Decrease (increase) in trade receivables (315) 821 1,089 1,456 Increase in inventory (500) (643) (506) (3,595) Decrease (increase) in other accounts receivable (69) 255 (312) (403) Increase (decrease) in trade payables 312 (169) (327) - Increase in other accounts payable 645 731 289 298 Increase (decrease) in deferred revenues and other liabilities 1,164 (313) 1,402 790 Total changes in asset and liability 1,237 682 1,635 (1,454) Cash paid and received during the period for: Interest paid (150) (12) (253) (46) Interest received 121 422 1,707 1,042 Income taxes paid - (107) (11) (443) Total cash paid and received during the period (29) 303 1,443 553 Net cash provided by (used in) operating activities: 2,474 (2,243) 1,284 (9,760) Cash flows from investing activities: Proceeds from (purchase of) property and equipment and system components, net (442) 428 (2,387) 1,936 Withdrawal of (investment in) short-term deposits, net (35,000) - (35,000) 40,254 Investment in long-term deposits, net (14) (1) (22) (21) Net cash provided by (used in) investing activities (35,456) 427 (37,409) 42,169 Cash flows from financing activities: Repayment of liability in respect of research and development grants (442) - (787) (977) Receipt of government grants - - 32 15 Repayment of lease liability (85) (73) (271) (533) Issuance of share capital, net - - - (52) Net cash used in financing activities (527) (73) (1,026) (1,547) Exchange rate differences on cash and cash equivalents 136 118 90 (202) Increase (decrease) in cash and cash equivalents (33,373) (1,771) (37,061) 30,660 Cash and cash equivalents at the beginning of the period 44,164 49,623 47,852 17,192 Cash and cash equivalents at the end of the period $10,791 $47,852 $10,791 $47,852 (a) Significant non cash transactions: Recognition of new lease liability and right-of-use 101 61 308 301 Termination of lease liability and right-of-use 29 - 99 - BRAINSWAY LTD. A reconciliation of Adjusted EBITDA to net loss, the most directly comparable IFRS measure, is set forth below: U.S. dollars in thousands (except share and per share data) For the three months ended December 31, For the year ended December 31, 2023 2022 2023 2022 (Unaudited) (Unaudited) (Audited) Net income (loss) and total comprehensive income (loss) $127 $(3,867) $(4,197) $(13,349) Finance (income) expense, net 221 (401) (1,013) 351 Income taxes (164) (55) 251 315 Depreciation and amortization 83 101 362 558 Depreciation of leased systems 256 241 975 976 Cost of share based payment 234 353 381 1,474 Restructuring and litigation Cost - - 852 - Adjusted EBITDA $757 $(3,628) $(2,389) $(9,675)

Feb. 29, 2024 -- 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 reached agreement with the U.S. Food and Drug Administration (FDA) on the adequacy and timing of long-term cytisinicline exposure data requirements for a New Drug Application (NDA). During pre-NDA discussions held in the fourth quarter of 2023, the FDA expressed support for an NDA submission based on adequate data to assess for efficacy from the two completed randomized and controlled Phase 3 trials, ORCA-2 and ORCA-3. In addition, the FDA advised that long-term exposure data to assess for safety beyond 12 weeks would be needed to adequately evaluate safety risks given that the FDA views smoking cessation drugs as products for chronic, repeat, or intermittent use as patients may relapse and require subsequent courses of treatment over a lifetime. 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. Based on FDA agreement, Achieve's NDA submission will include safety data on at least 300 subjects who have received cumulative cytisinicline treatment for six months. Prior to potential approval, Achieve will provide the FDA with safety data from at least 100 subjects treated with cytisinicline for a cumulative duration of one year. 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). ORCA-OL will recruit from the more than 1,700 subjects who have participated in these prior trials, including more than 1,100 who have already received cytisinicline treatment for either 6 or 12-weeks. The required total cumulative exposure data for NDA submission and potential final approval will combine the previous subjects’ treatment received during their respective ORCA-2, ORCA-3, or ORCA-V1 study participation plus their exposure during the ORCA-OL study. This allows for faster collection of cumulative long-term exposure safety data for the NDA submission. Subjects in ORCA-OL will receive cytisinicline treatment for up to one year and will be monitored for safety. “We anticipate that data from this long-term exposure study will support the expected use of cytisinicline by patients multiple times throughout their journey to nicotine abstinence,” commented Cindy Jacobs, Achieve’s President & Chief Medical Officer. “Additionally, we expect this safety data will be supportive of a future cytisinicline label expansion for vaping cessation.” Achieve also announced an approximately $124.2 million financing, which includes $60 million upfront from the sale of common stock and up to an additional $64.2 million upon the exercise of milestone-driven warrants. The milestone-driven warrants 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 an NDA for cytisinicline by the FDA in a Day 74 Letter or equivalent correspondence. Achieve has also reached non-binding agreement with Silicon Valley Bank on an extension of the maturity date into December 2025 on its outstanding loan. “We are pleased to now have clarity from the FDA and we are excited about the vote of confidence from leading life science investors who share our enthusiasm for cytisinicline’s potential,” said John Bencich, Achieve’s Chief Executive Officer. “As we continue our discussions with potential commercial partners, we are funded to conduct the ORCA-OL trial and complete the planned NDA submission, bringing us closer to our goal of helping the millions of people who struggle with nicotine dependence.” Achieve expects that existing cash, cash equivalents and restricted cash, together with the net proceeds from the financing, will provide adequate funding through the anticipated NDA filing in the first half of 2025. If all of the milestone-driven warrants are exercised in full, Achieve expects to have runway into 2026 and through potential FDA approval. 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. 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. The content above comes from the network. if any infringement, please contact us to modify.