Core Viewpoint - Achieve Life Sciences, Inc. is conducting a public offering of 15 million shares of common stock and accompanying warrants at a price of $3.00 per share, aiming to raise approximately $45 million to support the development of cytisinicline for nicotine dependence treatment [1][4]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence and smoking cessation [7]. - The company submitted a New Drug Application to the FDA for cytisinicline in June 2025, based on successful Phase 3 studies and an open-label safety study [7]. Offering Details - The public offering includes 15 million shares and warrants, with an additional 2.25 million shares available for underwriters to purchase [1][3]. - Each common warrant can be exercised for common stock at $3.00 or for pre-funded warrants at $2.999, expiring five years from issuance [2]. Financial Aspects - The gross proceeds from the offering are expected to be around $45 million, which will be used for advancing cytisinicline towards FDA approval and for general corporate purposes [4]. - The offering is expected to close around June 30, 2025, pending customary closing conditions [3]. Market Context - There are approximately 29 million adult smokers in the U.S., with tobacco use being the leading cause of preventable death [8]. - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the need for effective treatments for nicotine e-cigarette cessation, as there are currently no FDA-approved options for this indication [9].

Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [5] - The company submitted its New Drug Application to the FDA for cytisinicline in June 2025, based on two completed Phase 3 studies and a fully enrolled open-label safety study [5] Offering Details - Achieve Life Sciences announced a proposed underwritten public offering to sell shares of its common stock and accompanying common warrants, with an option for underwriters to purchase an additional 15% of the shares [1][2] - The proceeds from the offering are intended to fund the advancement of cytisinicline through potential FDA marketing approval and for working capital and general corporate purposes [2] Market Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, responsible for over eight million deaths globally and nearly half a million in the U.S. annually [6] - There are around 17 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need for effective solutions [7] Product Information - Cytisinicline is a plant-based alkaloid with a high binding affinity to nicotinic acetylcholine receptors, believed to aid in treating nicotine addiction by reducing craving symptoms and the satisfaction associated with nicotine products [8][9] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address the urgent need for treatments for nicotine dependence [7]

Core Insights - Achieve Life Sciences has partnered with Omnicom as its strategic innovation partner to support the U.S. commercial launch of cytisinicline, a treatment for nicotine dependence [1][2][3] - The collaboration aims to leverage advanced technologies and a comprehensive marketing strategy to address a significant public health issue related to smoking cessation [4][5] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline for smoking cessation, having submitted its New Drug Application (NDA) to the FDA on June 25, 2025 [7] - The company has completed two Phase 3 studies and is currently conducting an open-label safety study for cytisinicline [4][7] Industry Context - Smoking is the leading cause of preventable death in the U.S., with over 29 million adults still smoking [4][8] - Cytisinicline is positioned as a potential breakthrough treatment for nicotine dependence, with the FDA granting it Breakthrough Therapy designation [8][9] Marketing Strategy - Omnicom's approach includes utilizing AI-enabled marketing technology to enhance targeting and engagement with healthcare professionals and patients [2][5] - The integrated team from Omnicom will provide expertise in consumer brand development, medical education, and strategic public relations to support the launch [3][4] Technological Integration - The collaboration will incorporate innovative technologies such as generative AI, predictive analytics, and social listening to improve targeting and personalization [5][6] - Partnerships with healthcare apps, pharmacies, and data providers will further expand the reach and insights of Achieve's marketing strategy [5]

Core Insights - Achieve Life Sciences has submitted a New Drug Application (NDA) to the FDA for cytisinicline, marking the first new pharmacotherapy option for nicotine dependence in two decades [1][4] - Cytisinicline has shown efficacy and safety in two large Phase 3 trials, ORCA-2 and ORCA-3, demonstrating significantly higher abstinence rates compared to placebo [2][3] - The public health burden of smoking affects nearly 29 million adults in the U.S., with smoking-related illnesses causing nearly half a million deaths annually [2][5] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment [4] - The company has also completed a Phase 2 study for vaping cessation and has received Breakthrough Therapy designation from the FDA for cytisinicline [6][4] Product Details - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors, potentially reducing nicotine cravings and satisfaction from nicotine products [7] - The NDA submission is supported by data from over 2,000 clinical trial participants, indicating a well-tolerated safety profile [1][2]

Achieve Life Sciences (ACHV) Conference Summary Company Overview - Achieve Life Sciences is focused on addressing nicotine dependence through its drug cytisinicline, which is positioned as a potential blockbuster treatment for smoking and vaping cessation [3][4][5] Industry Context - The U.S. faces a significant public health crisis with approximately 46 million individuals affected by nicotine dependence, including 29 million smokers and 17 million vapers [3][4] - The vaping population has increased by 6 million in the last 24 months, highlighting a growing concern [4] Key Points and Arguments 1. **Market Opportunity**: - The addressable market for nicotine dependence treatment is substantial, with an estimated annual market opportunity of $11 billion based on previous treatments like Chantix [33][35] - There are 15.4 million annual attempts to quit smoking, indicating a high demand for effective cessation tools [33] 2. **Product Development**: - Cytisinicline is expected to be the first new treatment for nicotine dependence in nearly 20 years, with an NDA filing planned for the end of June 2025 and anticipated FDA approval by mid-2026 [5][22] - The drug has shown a differentiated efficacy profile in clinical trials, with odds ratios of 5.3 and 5.8 in two phase three trials, indicating a significantly higher likelihood of quitting compared to existing treatments [19][20] 3. **Clinical Trials**: - Cytisinicline has undergone two large-scale phase three clinical trials involving over 1,600 patients, demonstrating robust efficacy and tolerability [5][25] - A phase two clinical trial for vaping cessation showed an odds ratio of 2.65, with plans for a phase three trial starting in early 2025 [27][23] 4. **Regulatory Pathway**: - The NDA submission is expected to be accepted within 74 days, with a clear regulatory pathway outlined by the FDA [22][43] 5. **Commercial Strategy**: - Achieve Life Sciences plans a targeted digital marketing strategy focusing on primary care physicians and patients, leveraging the lack of competition in the smoking cessation market since Chantix became generic [30][39] - The company aims to change the narrative around nicotine dependence from a lack of willpower to a medical condition, enhancing awareness and acceptance of cytisinicline [35][36] 6. **Safety and Tolerability**: - Cytisinicline has a favorable safety profile, with side effects significantly lower than those of existing treatments like Chantix, particularly in terms of nausea and vomiting [20][21] Additional Insights - The company has a strong intellectual property position and a proven leadership team, which is expected to drive shareholder value [43][44] - There is potential for future indications beyond nicotine dependence, including cannabis use, although the focus remains on the immediate market opportunity [50][52] Conclusion - Achieve Life Sciences is positioned to make a significant impact in the nicotine dependence treatment market with cytisinicline, addressing a critical public health issue while leveraging a well-defined commercial strategy and strong clinical data [44][54]

Group 1 - The article discusses the experience of an investor who began trading during the pandemic and emphasizes the importance of analyzing earnings reports to identify potential growth stocks [1] - The investor successfully identified several future winners, including OPRX, OTRK, FUBO, and PLUG, by focusing on key information from earnings transcripts and reports [1]

Company Overview - Achieve Life Sciences, Inc. is a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment for nicotine dependence and smoking cessation [3] - The company has successfully completed two Phase 3 studies and one Phase 2 study related to cytisinicline for smoking and vaping cessation [3] - Achieve plans to submit its new drug application for smoking cessation in June 2025 and has conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [3] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [6] - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death, responsible for over eight million deaths worldwide annually [4] - There are over 11 million adults in the U.S. who use e-cigarettes, with no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [5] Upcoming Events - Rick Stewart, CEO of Achieve, will present at the Jefferies Global Healthcare Conference on June 4, 2025, at 5:30 PM EDT, with a live webcast available on the company's Investor Relations website [2]

Core Insights - Achieve Life Sciences is presenting additional analyses from its Phase 3 ORCA-3 study on cytisinicline at the 2025 ATS International Conference, emphasizing its dual mechanism of action in treating nicotine dependence [1][8] - Cytisinicline has shown significant efficacy in reducing nicotine cravings and intake, even among smokers who do not completely quit, indicating its potential as a therapeutic option for smoking cessation [3][4] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing cytisinicline for nicotine dependence and smoking cessation, having completed two Phase 3 studies and one Phase 2 study for vaping cessation [7] - The company plans to submit a New Drug Application for cytisinicline in June 2025, aiming to address the smoking health epidemic affecting millions [6][7] Clinical Findings - The ORCA-3 study demonstrated a significant reduction in craving scores (p=0.0001) and serum cotinine levels among participants treated with cytisinicline compared to placebo, with a reduction equivalent to nearly four times more in cotinine levels [4][5] - Cytisinicline's dual action as a selective partial agonist and antagonist at the nicotinic acetylcholine receptor may help smokers reduce their nicotine intake while on the path to quitting [3][5] Market Context - There are approximately 29 million adult smokers in the U.S., with smoking being the leading cause of preventable death, highlighting the critical need for effective cessation treatments [9] - Cytisinicline has received Breakthrough Therapy designation from the FDA, indicating its potential to address the urgent need for effective nicotine cessation therapies [10][11]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled $23.2 million [19] - Total operating expenses for Q1 2025 were $12.9 million, resulting in a net loss of $12.8 million [19] Business Line Data and Key Metrics Changes - The company is focused on the NDA submission for cytisinicline, which is expected to be submitted in June 2025 [6][12] - The ORCA-OL open label study has over 100 patients with one year of exposure to cytisinicline, demonstrating strong tolerability [10][14] Market Data and Key Metrics Changes - In the U.S., over 29 million adults smoke cigarettes, and 11 million vape, with more than half wanting to quit but fewer than 10% succeeding due to inadequate tools [7] - Cytisinicline, if approved, will be the first new nicotine dependence drug in nearly 20 years, addressing a significant unmet need in the market [8][17] Company Strategy and Development Direction - The company aims to change the perception of nicotine dependence as a serious medical condition that requires treatment, similar to how GLP-1 medications have reframed obesity treatment [9] - The management is focused on ensuring a high-quality NDA submission and preparing for a potential commercial launch in 2026 [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the NDA submission process and the potential impact of cytisinicline on public health, particularly in treating nicotine dependence and related chronic conditions like COPD [21][66] - The company is committed to prudent cash management to extend its cash runway while focusing on the NDA submission [20] Other Important Information - The ORCA-three clinical trial results published in JAMA Internal Medicine reaffirm cytisinicline's efficacy and tolerability for helping adult smokers quit [16] - The company convened a Scientific Advisory Board meeting with leading experts to discuss cytisinicline and gather insights for the NDA filing and commercial plans [15] Q&A Session Summary Question: How long before we see the full safety data from the long-term study? - The company expects to complete the study by June to September 2025 and will present the data after the NDA submission [27] Question: What were some of the key takeaways from the SAB meeting? - The SAB meeting highlighted the enthusiasm of key opinion leaders for cytisinicline and discussed its potential applications in various settings [30][32] Question: What are your plans for pre-commercial efforts to increase awareness of cytisinicline? - The company is focusing on awareness, availability, and access, ensuring the drug is ready for sale and working on pricing and payer strategies [36][38] Question: What is the status of any partnership discussions for non-dilutive capital? - The company is specifying its needs for partnerships related to COPD and is in discussions with potential candidates [44] Question: Have there been any changes in interactions with the FDA? - There have been no significant changes; interactions have remained consistent as the company approaches the NDA submission [48] Question: How are pricing discussions with payers going? - Initial conversations have occurred, but strong perspectives will emerge once pricing is set [52] Question: Will the company rely on external partners for commercialization? - The company will heavily rely on agency partners to implement its strategy and digital launch roadmap [59] Question: When will commercialization begin after product approval? - The company anticipates needing some time post-approval to ensure a strong launch, but aims to start as close to approval as possible [61]

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled $23.2 million [19] - Total operating expenses for Q1 2025 were $12.9 million, resulting in a net loss of $12.8 million [19] Business Line Data and Key Metrics Changes - The company is focused on the NDA submission for cytisinicline, which is expected to be submitted in June 2025 [6][12] - The ORCA-OL open label study has over 100 patients with one year of exposure to cytisinicline, demonstrating strong tolerability [10][14] Market Data and Key Metrics Changes - In the U.S., over 29 million adults smoke cigarettes, and 11 million vape, with more than half wanting to quit but fewer than 10% succeeding due to inadequate tools [7] - Cytisinicline is positioned to be the first new nicotine dependence drug in nearly 20 years, addressing a significant unmet need in the market [8][17] Company Strategy and Development Direction - The primary focus is on treating nicotine dependence and addressing comorbidities associated with smoking, such as COPD [21][22] - The company aims to build a foundation for long-term growth and create lasting value for stockholders through prudent cash management and resource allocation [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the NDA submission process and the potential impact of cytisinicline on public health [6][66] - The company anticipates a 12-month timeline for NDA approval following submission, with a potential commercial launch in 2026 [20][66] Other Important Information - The ORCA-three clinical trial results were published in JAMA Internal Medicine, reaffirming cytisinicline's efficacy and tolerability [15][16] - The company convened a Scientific Advisory Board meeting with experts in nicotine and tobacco cessation research, highlighting the excitement surrounding cytisinicline [15][31] Q&A Session Summary Question: How long before we see the full safety data from the long-term study? - The full safety data will be compiled after the NDA submission and presented at a conference later this year or next year [27] Question: What were some key takeaways from the SAB meeting? - The SAB meeting discussed the applications of cytisinicline treatment and the enthusiasm of key opinion leaders regarding its efficacy and tolerability [29][31] Question: What are the plans for pre-commercial efforts to increase awareness of cytisinicline? - The company is focusing on awareness, availability, and access, ensuring the drug is ready for sale and working on pricing and payer strategies [35][36] Question: What is the status of any partnership discussions for non-dilutive capital? - The company is specifying what it wants from potential partnerships, particularly in the COPD space, and is in discussions with several candidates [41][43] Question: Have there been any changes in interactions with the FDA? - There have been no significant changes; interactions have remained responsive as the NDA submission approaches [47] Question: How are pricing discussions with payers going? - Initial conversations have occurred, but strong perspectives will emerge once pricing is set and further exchanges take place [52] Question: Will the company rely on external partners for commercialization? - The company will heavily rely on agency partners to implement its strategy and build a digital launch roadmap [59]