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]

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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]

Achieve Life Sciences (ACHV) Q1 2025 Earnings Call May 13, 2025 08:30 AM ET Company Participants Nicole Jones - Investor RelationsRichard Stewart - CEO & DirectorCindy Jacobs - President, Chief Medical Officer & DirectorMark Oki - CFOGary Nachman - Managing Director - Equity ResearchJaime Xinos - Chief Commercial Officer Conference Call Participants Justin Walsh - Director & Research AnalystJohn Vandermosten - Senior Analyst Operator Greetings. Welcome to Achieve Life Sciences First Quarter twenty twenty fi ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled $23.2 million [16] - Total operating expenses for Q1 2025 were $12.9 million, resulting in a net loss of $12.8 million [16] 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 [5][10] - The ORCA-OL open label study has over 100 patients with one year of exposure to cytisinicline, demonstrating strong tolerability [8][12] 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 [6] - Cytisinicline is positioned to be the first new nicotine dependence drug in nearly 20 years, addressing a significant unmet need in the market [7][15] 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 [7] - Achieve Life Sciences is preparing for a potential commercial launch in 2026, focusing on managing resources wisely to support this goal [16][17] 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 [19][60] - The company is optimistic about cytisinicline's ability to address comorbidities associated with smoking, particularly in COPD patients [18][19] Other Important Information - The ORCA-three clinical trial results were published in JAMA Internal Medicine, reaffirming cytisinicline's efficacy and tolerability [14] - The company is actively engaging with key opinion leaders to gather insights and support for the NDA filing and commercial plans [13][29] Q&A Session Summary Question: When will the full safety data from the long-term study be available? - The company plans to compile and present the safety data after the NDA submission and the 120-day safety update in October [24] Question: What were the key takeaways from the SAB meeting? - The SAB meeting highlighted the enthusiasm for cytisinicline and discussed its potential applications in various settings, including hospital environments [27][29] Question: What are the plans for pre-commercial efforts to increase awareness of cytisinicline? - The company is focusing on awareness, availability, and access, ensuring that physicians are informed about the new treatment option [33][34] Question: What is the status of partnership discussions for non-dilutive capital? - The company is specifying its needs for partnerships related to COPD and is in discussions with potential candidates [39] 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 [43] Question: How are pricing discussions with payers progressing? - Initial conversations with payers have occurred, but strong perspectives will emerge after pricing is set [48] Question: Will the company rely on external partners for commercialization? - The company plans to leverage agency partners for implementing its digital launch strategy [53] Question: When can the market expect first sales post-approval? - The company anticipates needing some time to establish the drug in the market following approval, aiming for a strong launch as soon as feasible [55]

Financial Performance - The net loss for the three months ended March 31, 2025, was $12.8 million, with an accumulated deficit of $218.4 million as of the same date[121]. - The company incurred an accumulated deficit of $218.4 million through March 31, 2025, and expects to incur substantial additional losses in the future[149]. - For the three months ended March 31, 2025, net cash used in operations was $11.1 million, an increase from $5.3 million for the same period in 2024, primarily due to higher R&D expenses[170]. - The company has substantial doubt regarding its ability to continue as a going concern without additional financing, which may be impacted by macroeconomic conditions[152]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years as it continues clinical development and seeks regulatory approval for its product candidate[154]. - The company has not generated any revenue from product sales to date and may not do so in the near future[149]. Research and Development - Research and development expenses increased to $7.1 million for the three months ended March 31, 2025, compared to $2.8 million for the same period in 2024, primarily due to costs from the ORCA-OL trial[141]. - The ORCA-OL trial completed enrollment of 479 subjects, with safety data from at least 300 subjects treated for six months to be included in the NDA submission[127][129]. - The FDA granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation in 2024, expediting its development[124]. - The company plans to submit the NDA for cytisinicline to the FDA in June 2025, following the completion of a long-term safety study initiated in May 2024[122]. Expenses and Income - General and administrative expenses rose to $5.8 million for the three months ended March 31, 2025, up from $3.2 million in the same period in 2024, driven by higher employee expenses and commercial launch preparation costs[142]. - Interest income decreased to $0.3 million for the three months ended March 31, 2025, compared to $0.4 million for the same period in 2024, due to lower average cash balances[143]. - Interest expense decreased to $0.2 million for the three months ended March 31, 2025, down from $0.8 million in the same period in 2024, attributed to a lower principal balance on the New Convertible Term Loan[144]. Cash and Financing - As of March 31, 2025, the company had a cash, cash equivalents, and marketable securities balance of $23.2 million, with a positive working capital balance of $17.9 million[149]. - The company raised approximately $60.0 million in gross proceeds from a registered direct offering in February 2024, receiving net proceeds of approximately $56.1 million after fees[168]. - The company entered into a New Debt Agreement on July 25, 2024, providing term loans with an aggregate original principal amount of $10.0 million, with additional loans available upon certain events[157]. - The New Convertible Term Loan matures on December 1, 2027, with an option to extend to June 1, 2028, and has an interest rate of at least 7.0%[158]. - For the three months ended March 31, 2025, net cash provided by investing activities was $11.4 million, attributed to transactions involving marketable securities[174]. Accounting Standards - New accounting standards will be adopted in 2025, as detailed in Note 2 of the unaudited consolidated financial statements[177].

Financial Performance - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities of $23.2 million, down from $34.4 million at the end of 2024[10][23] - Total operating expenses for Q1 2025 were $12.9 million, compared to $6.0 million in Q1 2024, reflecting a 115% increase year-over-year[21] - The net loss for Q1 2025 was $12.8 million, compared to a net loss of $6.5 million in the same quarter of the previous year, representing a 97% increase[21] - Achieve's stockholders' equity decreased to $10.3 million as of March 31, 2025, from $20.9 million at the end of 2024[23] Clinical Trials and Drug Development - Achieve Life Sciences plans to submit a New Drug Application (NDA) for cytisinicline to the FDA in June 2025[1] - Approximately 75% of the 479 participants in the ORCA-OL trial remain on treatment, indicating strong tolerability of cytisinicline[4] - The Phase 3 ORCA-3 trial involved 792 U.S. adult smokers and demonstrated efficacy in reducing nicotine cravings and improving quit rates[6] - Achieve has met FDA long-term exposure requirements with safety data from over 300 participants completing six months of treatment and 100 participants completing one year[7] - The company completed its third safety review of the ORCA-OL trial, with no unexpected treatment-related adverse events reported[8] - The company conducted a Science Advisory Board meeting with leading experts to discuss clinical progress and NDA preparations for cytisinicline[9]