Core Viewpoint - Achieve Life Sciences, Inc. has successfully closed a public offering of 15 million shares of common stock, raising gross proceeds of $45 million to advance the development of cytisinicline for nicotine dependence treatment [1][2]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline as a treatment for nicotine dependence, with a New Drug Application submitted to the FDA in June 2025 [5]. - The company has completed two Phase 3 studies and an open-label safety study for cytisinicline, and has also conducted a Phase 2 study for vaping cessation [5]. Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aimed at reducing nicotine cravings and the satisfaction derived from nicotine products [7]. - Approximately 29 million adults in the U.S. smoke combustible cigarettes, and tobacco use is the leading cause of preventable death globally, with over 8 million deaths annually [6]. - There are currently no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a critical need that cytisinicline aims to address [6]. Financial Details - The public offering included 15 million shares at a price of $3.00 per share, along with warrants to purchase up to 16,766,666 additional shares [1]. - Proceeds from the offering will be used for advancing cytisinicline towards FDA marketing approval and for general corporate purposes [2].

SEATTLE and VANCOUVER, British Columbia, June 26, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced a proposed underwritten public offering in which it intends to offer and sell shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and accompanying common wa ...

Smoking, the leading cause of preventable death and disease, continues to affect nearly 29 million adults in the U.S. alone If approved, cytisinicline will be the first new FDA-approved pharmacotherapy option for nicotine dependence in two decades More than 2,000 clinical trial participants contributed to the body of evidence submitted in the NDA demonstrating cytisinicline’s efficacy, safety, and tolerability profile SEATTLE and VANCOUVER, British Columbia, June 26, 2025 (GLOBE NEWSWIRE) -- Achieve Life S ...

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]

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]

Core Viewpoint - Achieve Life Sciences plans to submit a New Drug Application (NDA) for cytisinicline to the FDA in June 2025, marking a significant milestone in the development of a new treatment for smoking cessation [1][2]. Company Developments - The company reported financial results for Q1 2025, with cash and equivalents totaling $23.2 million and a net loss of $12.8 million for the quarter [10][20]. - Achieve has successfully completed the FDA's long-term exposure requirements for cytisinicline, demonstrating safety data on over 300 participants completing six months and 100 participants completing one year of treatment [6][8]. - The company conducted a Science Advisory Board (SAB) meeting with leading experts to discuss clinical progress and NDA preparations [9]. Clinical Trial Results - The Phase 3 ORCA-3 trial results published in JAMA Internal Medicine confirmed cytisinicline's efficacy and tolerability, showing reduced nicotine cravings and extended quit rates through 24 weeks [5][8]. - In the ORCA-OL long-term exposure trial, 75% of the 479 enrolled participants remained on treatment, indicating the potential for cytisinicline to shift the treatment paradigm for smoking cessation [4][6]. Market Context - There are approximately 29 million adults in the U.S. who smoke combustible cigarettes, with tobacco use being the leading cause of preventable death [13]. - Cytisinicline has been granted Breakthrough Therapy designation by the FDA, addressing the critical need for effective treatments for nicotine dependence, including e-cigarette cessation [14][15].

Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q4 2024 Earnings Conference Call March 11, 2025 8:30 AM ET Company Participants Nicole Jones - IR Richard Stewart - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jaime Xinos - Chief Commercial Officer Mark Oki - Chief Financial Officer Conference Call Participants Gary Nachman - Raymond James Thomas Flaten - Lake Street Capital Markets Francois Brisebois - Oppenheimer and Company Justin Walsh - Jones Trading Brandon Folkes - Rodman & Ren ...