Financial Performance - The net loss for the nine months ended September 30, 2024, was $27.5 million, with an accumulated deficit of $193.2 million[119]. - The company has not generated any revenue from product sales to date and has incurred operating losses each year since inception[119]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development[120]. - The accumulated deficit through September 30, 2024 was $193.2 million, with expectations of incurring substantial additional losses in the future[170]. - For the nine months ended September 30, 2024, net cash used in operations was $20.6 million[170]. - The company incurred a loss on extinguishment of debt of $0.3 million for each of the three and nine months ended September 30, 2024[169]. - Substantial doubt exists regarding the company's ability to continue as a going concern without additional financing[173]. Cash and Investments - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $42.9 million, and a positive working capital balance of $38.8 million[119]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $47.8 million, significantly higher than $15.3 million in the same period of 2023, driven by proceeds from the February 2024 offering and other financing activities[199]. - Net cash used in investing activities increased to $33.3 million for the nine months ended September 30, 2024, compared to only $15,000 in the same period of 2023, attributed to transactions involving marketable securities[200]. - As of September 30, 2024, the company had $50.0 million available under an Open Market Sale Agreement with Jefferies LLC, although no shares were sold under this agreement during the three and nine months ended September 30, 2024[197]. Clinical Trials and Drug Development - The FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation, which allows expedited development of the drug[125]. - The company initiated the ORCA-OL open label trial in May 2024, enrolling 479 subjects to provide long-term safety data for cytisinicline[127]. - In the Phase 2b ORCA-1 trial, cytisinicline treatment arms showed a 74-80% median reduction in the number of cigarettes smoked compared to a 62% reduction in placebo arms[133]. - The 3 mg TID cytisinicline arm demonstrated a 50% abstinence rate at week 4, compared to 10% for placebo (p<0.0001)[135]. - The ORCA-V1 trial showed a vaping cessation rate of 31.8% for cytisinicline compared to 15.1% for placebo during weeks 9 through 12 (p=0.04)[141]. - The Phase 3 ORCA-2 trial demonstrated that subjects receiving 12 weeks of cytisinicline had a 6.3 times higher likelihood of quitting smoking compared to placebo, with an abstinence rate of 32.6% versus 7.0%[144]. - The continuous abstinence rate from week 9 to 24 for the 12-week cytisinicline arm was 21.1%, compared to 4.8% for placebo, with an odds ratio of 5.3[145]. - The Phase 3 ORCA-3 trial showed that subjects receiving 12 weeks of cytisinicline had a 4.4 times higher likelihood of quitting smoking, with a cessation rate of 30.3% compared to 9.4% for placebo[150]. - Cytisinicline was well tolerated in both ORCA-2 and ORCA-3 trials, with no treatment-related serious adverse events reported[154]. Research and Development Expenses - R&D expenses for the three months ended September 30, 2024, increased to $7.6 million from $3.6 million in the same period in 2023, primarily due to the initiation of the ORCA-OL trial[162]. - The company initiated the ORCA-OL trial in May 2024, contributing to higher R&D expenses, while costs associated with completed trials (ORCA-3 and ORCA-V1) were reduced[198]. General and Administrative Expenses - General and administrative expenses for the three months ended September 30, 2024, rose to $4.9 million from $3.0 million in the same period in 2023, attributed to higher employee and consulting costs[164]. Financing Activities - In May 2023, the company sold 3,000,000 shares of common stock at $5.50 per share, raising approximately $15.3 million in net proceeds after fees and expenses[194]. - In February 2024, the company sold 13,086,151 shares of common stock at $4.585 per share, resulting in gross proceeds of approximately $60.0 million and net proceeds of about $56.1 million after deducting fees[197]. - The company issued unregistered warrants to purchase up to 13,086,151 shares at an exercise price of $4.906 per share, which are immediately exercisable and will expire under specific conditions[196]. Accounting Policies - There have been no material changes to the company's critical accounting policies since December 31, 2023, as disclosed in the Annual Report filed on March 28, 2024[202]. - The company has adopted new accounting standards in 2024, as detailed in the consolidated financial statements[203].

Financial Performance - As of September 30, 2024, the company's cash, cash equivalents, restricted cash, and short-term investments totaled $42.9 million[8] - Total operating expenses for the three months ended September 30, 2024 were $12.5 million, compared to $6.6 million for the same period in 2023, representing an increase of 90%[15] - The net loss for the three months ended September 30, 2024 was $12.5 million, compared to a net loss of $7.1 million for the same period in 2023, indicating an increase of 76%[15] - The total net loss for the nine months ended September 30, 2024 was $27.5 million, compared to $24.3 million for the same period in 2023[15] - Achieve's total assets as of September 30, 2024 were $47.9 million, significantly up from $19.4 million as of December 31, 2023[16] Clinical Development - Achieve completed enrollment in the Phase 3 ORCA-OL clinical trial with 479 participants across 29 U.S. sites, evaluating a 3 mg cytisinicline regimen for smoking and vaping cessation[3] - The FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation, aimed at expediting development and review[6] - The company plans to submit a New Drug Application (NDA) in the second quarter of 2025[3] Leadership and Strategy - Achieve's leadership team has been enhanced with the appointment of Richard Stewart as CEO and Thomas King as Executive Chairman, focusing on strategic growth[7] - The company has initiated the formation of a dedicated U.S. product launch preparedness team to support the upcoming market entry of cytisinicline[3]

Core Points - Achieve Life Sciences, Inc. is focused on the development and commercialization of cytisinicline for nicotine dependence treatment, with recent presentations at a joint FDA and NIH meeting aimed at advancing smoking cessation treatments [1][2] - Cytisinicline is currently the only late-stage nicotine dependence treatment, having completed two Phase 3 clinical trials with over 1,600 subjects, demonstrating strong safety and efficacy [2] - The FDA has not approved a new prescription smoking cessation treatment in nearly two decades, highlighting the need for innovation in this area [2] Company Overview - Achieve Life Sciences aims to address the global smoking health crisis, with approximately 29 million adults and 2.25 million middle and high school students in the U.S. smoking combustible cigarettes [4] - Tobacco use is the leading cause of preventable death, responsible for over 8 million deaths globally and nearly half a million in the U.S. annually [4] - There are over 11 million adults in the U.S. using e-cigarettes, with no FDA-approved treatments specifically for e-cigarette cessation [4] Product Details - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors, aiming to reduce nicotine cravings and satisfaction associated with nicotine products [5] - The drug has a revised formulation and dosing schedule compared to its predecessor, which had a complex 25-day titration regimen [2] - Achieve Life Sciences is preparing for a New Drug Application (NDA) filing and potential approval, following the completion of a long-term safety exposure study [2]

Core Insights - Achieve Life Sciences has promoted Ms. Jaime Xinos to Chief Commercial Officer to lead the commercial operations and strategic preparations for the anticipated U.S. launch of cytisinicline, a treatment for nicotine dependence [1][2][3] Company Overview - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline, targeting the nicotine addiction epidemic, with approximately 29 million adults in the U.S. smoking combustible cigarettes [4] - The company aims to address the health impacts of tobacco use, which is responsible for over eight million deaths worldwide annually, including nearly half a million in the U.S. [4] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, potentially aiding in smoking and e-cigarette cessation by reducing cravings and the satisfaction associated with nicotine [5] - Currently, there are no FDA-approved treatments specifically for e-cigarette cessation, highlighting a significant market opportunity for cytisinicline [4][5] Leadership and Strategy - Ms. Xinos brings nearly 25 years of experience in the biotechnology and pharmaceutical industries, having held leadership roles at major companies such as Pfizer and Novartis [3] - The company plans to forge strategic partnerships with commercialization experts to navigate the challenges faced by small biotech firms launching their first product [2][3]

SEATTLE and VANCOUVER, British Columbia, Oct. 01, 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, is pleased to announce the appointment of Dr. Mark L. Rubinstein as its new Head of Medical Affairs. Dr. Rubinstein brings more than two decades of experience in clinical medicine, scientific research, and medical affairs leadership, w ...

Leadership Changes - Richard Stewart reassumes the role of Chief Executive Officer, replacing John Bencich who will serve as an advisor during the transition [1] - Thomas King is appointed as the Executive Chairman of the Board of Directors [1] - The leadership change is driven by the need for a CEO with substantial M&A and commercial experience to push the company towards critical milestones, including potential licensing or strategic transactions for the commercialization of cytisinicline [2] Company Objectives and Progress - The company remains on track to meet its objectives for the year, including completing enrollment for the ORCA-OL study, meeting with the FDA for the End-of-Phase 2 meeting for vaping cessation under Breakthrough Therapy designation, and progressing towards the NDA submission expected in the first half of 2025 [2] - The company aims to bring forward a potentially life-changing treatment for nicotine dependence while optimizing shareholder value [2] Industry Context and Market Opportunity - Approximately 29 million adults in the United States smoke combustible cigarettes, contributing to over eight million deaths worldwide annually, with smoking being the leading cause of preventable death [3] - Over 11 million adults in the United States use e-cigarettes, and approximately 2.1 million middle and high school students reported using e-cigarettes in 2023 [3] - There are currently no FDA-approved treatments specifically indicated for nicotine e-cigarette cessation, highlighting a significant unmet medical need [3] Product Overview - Cytisinicline is a plant-based alkaloid with high binding affinity to the nicotinic acetylcholine receptor, believed to aid in treating nicotine addiction by reducing withdrawal symptoms and the reward associated with nicotine products [4] - Cytisinicline is an investigational product candidate for nicotine addiction treatment and has not yet received FDA approval [4]

Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Nicole Jones - IR John Bencich - CEO Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Justin Walsh - JonesTrading John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Thomas Flaten - Lake Street Capital Operator Greetings, and welcome to the Achieve Life Sciences Second Quarter ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ______________ TO ____________. Commission file number 033-80623 Achieve Life Sciences, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 95-4343413 (St ...

Exhibit 99.1 Achieve Life Sciences Reports Financial Results for Second Quarter 2024 and Provides Corporate Update Company to host conference call at 4:30 PM EDT today, Tuesday, August 13, 2024 SEATTLE, Wash and VANCOUVER, British Columbia, August 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 res ...

SEATTLE 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 nic ...