SEATTLE and VANCOUVER, British Columbia, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced that effective October 1, 2025, Achieve’s board of directors approved stock option grants to purchase an aggregate of 161,000 shares of its common stock for five new employees under Achieve’s 2024 E ...

SEATTLE and VANCOUVER, British Columbia, Sept. 22, 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 treatment of nicotine dependence, today announced the publication of new data in Thorax demonstrating that cytisinicline significantly improved smoking quit rates compared to placebo in adults with and without chronic obstructive pulmonary disease (COPD). The Thorax pub ...

Donnelly brings more than 25 years of biopharmaceutical expertise in CMC and regulatory operationsSEATTLE and VANCOUVER, British Columbia, Sept. 18, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline for treatment of nicotine dependence for smoking cessation, today announced the promotion of Craig Donnelly to Chief Operations Officer. Mr. Donnelly has been with Achieve sin ...

Core Insights - Achieve Life Sciences, Inc. has appointed Mark Rubinstein, M.D. as Interim Chief Medical Officer, succeeding Cindy Jacobs, Ph.D., M.D. [1][3] - The company is focused on the development and commercialization of cytisinicline for nicotine dependence treatment, with recent FDA acceptance of its New Drug Application [3][4] - Cytisinicline is positioned as a potential treatment for the estimated 15 million American adults who attempt to quit smoking each year [3] Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company dedicated to addressing the global nicotine dependence epidemic through cytisinicline [4] - The FDA has set a PDUFA completion date of June 20, 2026, for the cytisinicline New Drug Application [4] - The company has completed a Phase 2 study for vaping cessation and had a successful end-of-Phase 2 meeting with the FDA for a future vaping indication [4] Industry Context - Approximately 29 million adults in the U.S. smoke combustible cigarettes, with tobacco use being the leading cause of preventable death globally [5] - There are around 17 million adults in the U.S. who use e-cigarettes, and no FDA-approved treatments currently exist specifically for nicotine e-cigarette cessation [5] - Cytisinicline has received Breakthrough Therapy designation from the FDA to address the unmet need in nicotine dependence treatment [5][6]

Achieve Life Sciences Conference Call Summary Company Overview - Achieve Life Sciences is focused on the development and commercialization of cytisinicline, a treatment for nicotine dependence, marking the first innovation in this space in nearly 20 years [2][3] Key Points Industry Context - There are approximately 29 million smokers and 17 million vapers in the U.S., indicating a significant public health issue related to nicotine dependence [2] - The company aims to change the narrative around nicotine dependence, positioning it as a medical condition rather than a lifestyle choice [3] Product Development and Approval - The FDA accepted the New Drug Application (NDA) for cytisinicline, with a PDUFA date anticipated in June 2026 [2][4] - The company is preparing for a gated launch, ensuring all manufacturing and supply chain processes are in place three months prior to the launch [4] Clinical Trials and Efficacy - The ORCA clinical trials demonstrated robust efficacy and safety for cytisinicline, which is expected to be a key focus during the FDA review [5][7] - The company has a strong supply chain with FDA-inspected manufacturers, mitigating typical regulatory risks [6][7] Commercial Strategy - Achieve Life Sciences targets high prescribers among the 46,000 primary care physicians in the U.S., focusing on early adopters who actively discuss smoking cessation with patients [9] - The company has identified two distinct patient demographics, one less digitally oriented and the other more digitally engaged, both concerned about health issues related to smoking [9][10] Market Opportunity - Approximately 600,000 prescriptions for nicotine dependence products are written monthly, with a significant market opportunity for cytisinicline [14] - The peak revenue for Chantix was $880 million in the U.S. with only 4% market penetration, indicating substantial room for growth [14][15] Insurance and Payer Engagement - Under the Affordable Care Act, there are two free treatments available for smoking cessation, and Achieve is working to ensure cytisinicline is accessible to patients [16] - Initial payer engagement will take six to nine months post-launch, but the company is implementing processes to expedite drug availability [17] Strategic Partnerships - Achieve Life Sciences is partnering with Omnicom to leverage their integrated marketing resources, optimizing targeting for both patients and physicians [18] - The collaboration aims to enhance awareness and prescription rates through rapid messaging adjustments based on feedback [11][12] Long-term Growth Strategy - The company is focused on building its infrastructure and exploring global opportunities, with a billion smokers worldwide, while initially concentrating on the U.S. market [22][23] - Discussions with potential partners for future commercialization strategies are ongoing, particularly as the market size dictates the need for additional support [22] Vaping Cessation Program - A phase 3 trial for vaping cessation is planned, mirroring the smoking cessation trial but with a shorter treatment period due to higher nicotine dependence among vapers [24] - The company recognizes the health risks associated with vaping and aims to target motivated individuals seeking to quit [27] Financial Position - Achieve Life Sciences raised $49 million, providing a financial platform to support the NDA approval and the launch of cytisinicline [28] - The company prefers debt and royalty financing for future funding needs, avoiding additional equity raises [28] Additional Insights - The company is aware of the challenges posed by changing prescribing habits and is actively working to build awareness among physicians and patients [8][12] - The integration of marketing resources from Omnicom is seen as a unique advantage that could enhance the company's market entry strategy [18]

Core Insights - Achieve Life Sciences has received FDA acceptance for its New Drug Application (NDA) for cytisinicline, marking a significant step towards potentially the first new FDA-approved pharmacotherapy for smoking cessation in two decades, with a PDUFA target date set for June 20, 2026 [2][4]. Company Overview - Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on developing and commercializing cytisinicline to address nicotine dependence and smoking cessation [5]. - The company has conducted extensive research, with over 2,000 clinical trial participants contributing to the evidence supporting cytisinicline's efficacy [3]. Clinical Trials and Efficacy - The ORCA-2 and ORCA-3 Phase 3 clinical trials demonstrated that cytisinicline, administered for either 6 or 12 weeks alongside standard behavioral support, resulted in significantly higher smoking abstinence rates compared to placebo [3]. - Safety data from the trials included over 400 participants with at least six months of cumulative exposure to cytisinicline, showing no new safety concerns [3]. Public Health Impact - Smoking is the leading cause of preventable death in the U.S., claiming nearly half a million lives annually and costing the economy over $600 billion each year [4][6]. - Approximately 15 million Americans attempt to quit smoking each year, highlighting the need for effective cessation tools [4]. Market Opportunity - There are about 29 million adults in the U.S. who smoke combustible cigarettes, and the company aims to provide a new treatment option for this population [6]. - Additionally, there are around 17 million adults using e-cigarettes, with no FDA-approved treatments currently available for nicotine e-cigarette cessation, indicating a significant unmet need [7]. Product Mechanism - Cytisinicline is a plant-derived alkaloid that interacts with nicotinic acetylcholine receptors in the brain, helping to reduce nicotine cravings and the satisfaction associated with nicotine products [8].

Core Viewpoint - Achieve Life Sciences Inc. is approaching a critical phase as it seeks FDA approval for cytisinicline, a potential new smoking cessation therapy, with a commercial launch anticipated in 2026 [1][8]. Company Developments - In June, Achieve Life Sciences submitted a New Drug Application (NDA) to the FDA for cytisinicline aimed at nicotine dependence for smoking cessation in adults [2]. - The NDA is backed by positive efficacy and safety results from two Phase 3 trials, ORCA-2 and ORCA-3, which showed significant improvements in abstinence rates compared to placebo [3][4]. Financial Aspects - The company raised approximately $45 million in June to support the advancement of cytisinicline through potential FDA marketing approval and for general corporate purposes, with funding expected to last into the second half of 2026 [5]. Market Potential - Analyst Brandon Folkes believes the next 12 to 18 months could represent a significant value inflection point for ACHV stock, as the current share price does not reflect the commercial potential of cytisinicline [6]. - Cytisinicline is positioned to address the shortcomings of existing therapies, with a potential pricing strategy ranging from $500 to $3,000 per month, justified by the economic costs of smoking [8]. Competitive Landscape - Cytisinicline's tolerability is highlighted as a key advantage over Pfizer's Chantix, which has faced usage limitations due to side effects [7]. - The global market for smoking cessation therapies is valued at $13 billion, with the potential for cytisinicline to capture a significant share, especially considering the previous success of Chantix, which generated nearly $1 billion annually in U.S. sales before its withdrawal [9].

Financial Data and Key Metrics Changes - Achieve Life Sciences closed the second quarter with a strengthened balance sheet following a successful $45 million public offering in June, which included common stock and warrants [29] - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $55.4 million, expected to support operations into 2026 [29] - Total operating expenses for the three and six months ended June 30, 2025, were $12.6 million and $25.5 million respectively, consistent with expectations as the company increased investment in regulatory and pre-commercial planning [30] - The net loss for the same periods was $12.7 million and $25.5 million respectively [30] Business Line Data and Key Metrics Changes - The company achieved three transformative milestones: the submission of a new drug application (NDA) for cytisinicline, a strategic partnership with Omnicom, and a capital raise of $49 million [5][6] - The NDA submission is supported by data from over 2,000 clinical trial participants, including results from two Phase III studies and long-term safety data [12][13] Market Data and Key Metrics Changes - There are approximately 29 million smokers in the U.S., with over 15 million attempting to quit each year, highlighting a significant market opportunity for cytisinicline [7] - The annual cost of smoking-related health issues in the U.S. is over $600 billion, indicating a substantial public health burden [8] Company Strategy and Development Direction - The company aims to change the narrative around nicotine dependence, positioning it as a medical condition that requires effective treatment options [7][24] - Achieve is focused on a data-driven approach to its commercial launch strategy, leveraging a proprietary AI-enabled platform for decision-making and performance optimization [19][26] - The strategic partnership with Omnicom is intended to enhance brand development, market access, and stakeholder engagement ahead of the product launch [18][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory process and anticipates receiving the FDA's Day 74 NDA acceptance letter in mid-September [31] - The company is committed to executing its strategy with financial prudence while preparing for a potential product launch in late 2026 [31][32] - Management highlighted the importance of building relationships with payers to ensure rapid access to cytisinicline following approval [22][23] Other Important Information - The company plans to complete the ORCA-OL study database by the end of the year and aims to present the results in 2026 [15][68] - Achieve is actively engaging with the FDA and has requested a priority review for the NDA submission, although a standard review is currently anticipated [50] Q&A Session Summary Question: Will the 120-day safety update include only 100 patients or the full 290? - The company will submit all subjects available at the time of the database cut, which will be more than 100 but not the full 290 [34] Question: How will commercial spending ramp up ahead of launch? - The company will incrementally increase pre-commercial activities prior to approval, with a disciplined approach to commercial investment [35][36] Question: Will cytisinicline be priced at a premium compared to generic options? - The company views cytisinicline as a branded product at a premium price, supported by its differentiated profile [37] Question: What initial contact methods will be used to reach providers? - The company plans to identify individual needs of targeted physicians and engage through various channels, including social media and email [40][42] Question: What is the overall safety profile of cytisinicline? - The safety profile remains consistent with previous data, with no new safety signals identified [46][47] Question: Will there be any updates on future clinical development before the end of the year? - The company plans to complete the ORCA-OL study database quickly and aims to present data at conferences in 2026 [66][68]

[Part I. Financial Information](index=7&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Consolidated Financial Statements (Unaudited)](index=7&type=section&id=Item%201%20Consolidated%20Financial%20Statements%20(unaudited)) Unaudited consolidated financial statements reveal the company's financial position, performance, and cash flows, noting increased losses and capital-raising activities [Consolidated Balance Sheets](index=7&type=section&id=Consolidated%20Balance%20Sheets) Consolidated Balance Sheet Highlights | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (%) | | :----------------------------- | :----------------------------- | :------------------------------- | :--------- | | Cash and cash equivalents | $51,874 | $12,753 | 306.8% | | Marketable securities | $3,523 | $21,607 | -83.7% | | Total current assets | $56,903 | $36,467 | 56.0% | | Total assets | $58,935 | $38,633 | 52.5% | | Total liabilities | $17,267 | $17,734 | -2.6% | | Total stockholders' equity | $41,668 | $20,899 | 99.4% | [Consolidated Statements of Loss and Comprehensive Loss](index=9&type=section&id=Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) Consolidated Statements of Loss Highlights | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Change (%) | | :-------------------------------- | :---------------------------------------------- | :---------------------------------------------- | :--------- | | Research and development expenses | $6,707 | $5,113 | 31.2% | | General and administrative expenses | $5,856 | $3,318 | 76.5% | | Net loss | $(12,718) | $(8,461) | 50.3% | | Basic and diluted net loss per common share | $(0.37) | $(0.25) | 48.0% | Consolidated Statements of Loss Highlights | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | Change (%) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | | Research and development expenses | $13,804 | $7,912 | 74.5% | | General and administrative expenses | $11,653 | $6,501 | 79.2% | | Net loss | $(25,545) | $(14,955) | 70.8% | | Basic and diluted net loss per common share | $(0.74) | $(0.50) | 48.0% | [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Consolidated Statements of Cash Flows Highlights | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | Change (YoY) | | :------------------------------------------ | :-------------------------------------------- | :-------------------------------------------- | :----------- | | Net loss | $(25,545) | $(14,955) | 70.8% | | Net cash used in operating activities | $(20,157) | $(10,209) | 97.4% | | Net cash provided by financing activities | $41,222 | $55,957 | -26.4% | | Net cash provided by (used in) investing activities | $18,056 | $(46,568) | Shift to net provision | | Net increase (decrease) in cash, cash equivalents and restricted cash | $39,121 | $(820) | Significant increase | | Cash, cash equivalents and restricted cash at end of the period | $51,894 | $14,776 | 251.2% | [Consolidated Statements of Stockholders' Equity](index=11&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Consolidated Stockholders' Equity Highlights | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (%) | | :-------------------------- | :----------------------------- | :------------------------------- | :--------- | | Common Stock Shares | 49,685,072 | 34,685,072 | 43.2% |\n| Additional Paid-in Capital | $272,670 | $226,343 | 20.5% |\n| Accumulated Deficit | $(231,123) | $(205,578) | -12.4% |\n| Total Stockholders' Equity | $41,668 | $20,899 | 99.4% | - The June **2025** **public offering** resulted in the issuance of **15,000,000 shares**, contributing **$41,222k** to **total stockholders' equity**[26](index=26&type=chunk) [Notes to Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) - **Achieve Life Sciences, Inc.** is a late-stage clinical specialty pharmaceutical company focused on developing **cytisinicline** for nicotine dependence[29](index=29&type=chunk) - The company has an **accumulated deficit** of **$231.1 million** as of **June 30, 2025**, and relies on future financing to support ongoing clinical development and commercialization[32](index=32&type=chunk) - A dispute exists with **Sopharma** regarding the engagement of third-party manufacturers for the **NDA** submission, which **Sopharma** alleges is a breach of agreement[38](index=38&type=chunk) Financial Instrument Summary | Financial Instrument | June 30, 2025 (in thousands) | | :------------------- | :----------------------------- | | Convertible debt | $9,548 | | Contingent consideration | $1,337 | - The **New Convertible Term Loan**, with an **original principal** of **$10.0 million**, matures on **December 1, 2027**, and includes potential additional tranches and conversion features into common stock[65](index=65&type=chunk)[67](index=67&type=chunk)[69](index=69&type=chunk) - The **June 2025 public offering** generated approximately **$41.2 million** in **net proceeds** from the sale of **15,000,000 shares** and accompanying warrants, with an additional **$4.0 million** from the **underwriters' option exercise**[87](index=87&type=chunk)[170](index=170&type=chunk) Stock-Based Compensation Expense Summary | Expense Category | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :----------------------- | :-------------------------------------------- | :-------------------------------------------- | | Research and development | $1,333 | $899 | | General and administrative | $3,787 | $1,843 | | Total stock-based compensation | $5,120 | $2,742 | - As of **June 30, 2025**, **total unrecognized compensation expense** for stock options was **$2.2 million** (over **~1.74 years**) and for restricted stock units was **$2.7 million** (over **~0.63 years**)[101](index=101&type=chunk)[103](index=103&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses cytisinicline development, regulatory milestones, financial performance, and liquidity for commercialization [Overview](index=23&type=section&id=Overview) - **Achieve Life Sciences, Inc.** is a late-stage clinical specialty pharmaceutical company dedicated to addressing the global nicotine dependence epidemic through the development and commercialization of **cytisinicline**[122](index=122&type=chunk) - **Cytisinicline** is a plant-based alkaloid believed to treat nicotine dependence by interacting with nicotine receptors, reducing withdrawal symptoms and nicotine satisfaction[124](index=124&type=chunk) - The company plans to commence commercial sales of **cytisinicline** in the U.S. in the **second half of 2026**, leveraging **AI-enhanced marketing** and digital infrastructure[126](index=126&type=chunk) Key Financial Metrics Summary | Metric | Value (as of June 30, 2025) | | :------------------------------------------ | :-------------------------- | | Net loss (six months ended) | $(25.5) million | | Accumulated deficit | $(231.1) million | | Cash, cash equivalents and marketable securities | $55.4 million | | Net cash used in operating activities (six months ended) | $(20.2) million | [Cytisinicline Regulatory Progress](index=23&type=section&id=Cytisinicline%20Regulatory%20Progress) - In **June 2025**, an **NDA** was submitted to the **FDA** for **cytisinicline** as a treatment for smoking cessation, supported by efficacy and safety data from **Phase 3 ORCA-2** and **ORCA-3** trials[128](index=128&type=chunk) - **Cytisinicline** received **Breakthrough Therapy designation** from the **FDA** in **Q3 2024** for nicotine e-cigarette (vaping) cessation[129](index=129&type=chunk) - The **FDA** agreed on a proposed single **Phase 3** study design for a future **sNDA** submission for vaping cessation, with an intent to initiate clinical development dependent on funding[130](index=130&type=chunk) - The **ORCA-OL** open-label safety trial reached milestones of **300+ subjects** completing **six months** of cumulative treatment in **January 2025** and **100+ subjects** completing **one year** in **April 2025**[132](index=132&type=chunk)[133](index=133&type=chunk) [License & Supply Agreements](index=24&type=section&id=License%20%26%20Supply%20Agreements) - The company has a license and supply agreement with **Sopharma** for **cytisinicline**, granting access to manufacturing, efficacy, and safety data, and exclusive use of trademarks[134](index=134&type=chunk) - A dispute arose with **Sopharma** after the company engaged third-party manufacturers for its **NDA** submission due to concerns about **Sopharma's FDA** pre-approval inspection readiness[135](index=135&type=chunk) - The fair value of the **contingent consideration liability** from the **Extab Corporation** acquisition was estimated at **$1.3 million** as of **June 30, 2025**, with a **$0.2 million** loss recognized for the **six months** ended **June 30, 2025**[137](index=137&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) Operating Expenses and Other Income/Expense Highlights | Expense Category | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Change (%) | | :----------------------------- | :---------------------------------------------- | :---------------------------------------------- | :--------- | | Research and development | $6,707 | $5,113 | 31.2% | | General and administrative | $5,856 | $3,318 | 76.5% | | Interest income | $192 | $833 | -76.9% | | Interest expense | $(191) | $(804) | -76.3% | | Change in fair value of contingent consideration | $(97) | $(57) | 70.2% | Operating Expenses and Other Income/Expense Highlights | Expense Category | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | Change (%) | | :----------------------------- | :-------------------------------------------- | :-------------------------------------------- | :--------- | | Research and development | $13,804 | $7,912 | 74.5% | | General and administrative | $11,653 | $6,501 | 79.2% | | Interest income | $514 | $1,201 | -57.2% | | Interest expense | $(376) | $(1,617) | -76.7% | | Change in fair value of contingent consideration | $(188) | $(109) | 72.5% | - Increases in **R&D expenses** were primarily due to costs from the **ORCA-OL** open-label safety trial, which was at full enrollment in **2025**[143](index=143&type=chunk) - Increases in **G&A expenses** were mainly due to higher employee costs (including **stock-based compensation**) and commercial launch preparation costs[145](index=145&type=chunk) - Decreases in interest income and expense were primarily due to lower average cash balances and a lower principal balance on the **New Convertible Term Loan** after refinancing, respectively[146](index=146&type=chunk)[147](index=147&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) - As of **June 30, 2025**, the company had an **accumulated deficit** of **$231.1 million**, cash, cash equivalents, and marketable securities of **$55.4 million**, and **net cash used in operating activities** of **$20.2 million** for the **six months** ended **June 30, 2025**[150](index=150&type=chunk) - Existing cash, cash equivalents, and marketable securities are expected to fund current operating expenses and capital expenditures into the **second half of 2026**, but additional funds are needed for clinical development and commercialization[151](index=151&type=chunk) - The company entered into a **New Debt Agreement** in **July 2024** for a **$10.0 million** **convertible term loan**, with potential for additional **$10.0 million**, maturing **December 1, 2027**[153](index=153&type=chunk)[154](index=154&type=chunk) - **Financing activities** included **net proceeds** of approximately **$56.1 million** from a **February 2024** registered direct offering and approximately **$41.2 million** from a **June 2025 public offering** (plus **$4.0 million** from **overallotment option exercise**)[164](index=164&type=chunk)[170](index=170&type=chunk) Cash Flow Activities Summary | Cash Flow Activity | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------------- | :-------------------------------------------- | | Operating Activities | $(20,157) | $(10,209) | | Financing Activities | $41,222 | $55,957 | | Investing Activities | $18,056 | $(46,568) | [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management evaluated disclosure controls and procedures, concluding effectiveness, with no material changes to internal control over financial reporting - The company's disclosure controls and procedures were evaluated and deemed effective as of **June 30, 2025**[178](index=178&type=chunk) - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting during the quarter ended **June 30, 2025**[179](index=179&type=chunk) [Part II. Other Information](index=31&type=section&id=Part%20II.%20Other%20Information) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) This section details comprehensive risks impacting the business, covering financing, product development, regulatory, commercialization, intellectual property, and operations [Risks Related to Our Financial Condition and Capital Requirements](index=31&type=section&id=Risks%20Related%20to%20Our%20Financial%20Condition%20and%20Capital%20Requirements) - The company requires substantial additional capital to complete development, regulatory approval, and commercialization of **cytisinicline**, with current funds insufficient for commercialization[182](index=182&type=chunk)[183](index=183&type=chunk) - As of **June 30, 2025**, the company has **$10.0 million** in principal debt, secured by substantially all assets (excluding intellectual property), which could impair financial flexibility and access to capital[186](index=186&type=chunk)[188](index=188&type=chunk) - The company has incurred an **accumulated deficit** of **$231.1 million** and expects continued losses, having never generated revenue from product sales[193](index=193&type=chunk)[196](index=196&type=chunk) - Cash balances held at third-party financial institutions, including **SVB**, exceed **FDIC** insurance limits, posing a risk if these institutions fail[200](index=200&type=chunk)[201](index=201&type=chunk) [Risks Related to the Development of Our Product Candidate Cytisinicline](index=34&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidate%20Cytisinicline) - **Cytisinicline** is the company's sole product candidate, and there is no guarantee of successful **FDA** approval or commercialization[202](index=202&type=chunk) - The development and commercialization of **cytisinicline** depend on securing sufficient quantities from natural plant sources, which grow in limited non-U.S. locations, posing supply risks[204](index=204&type=chunk) - The **FDA** may require additional clinical or nonclinical studies for **cytisinicline**, or may not grant marketing approval at all, despite the **NDA** submission[205](index=205&type=chunk)[207](index=207&type=chunk) - Clinical trials, including the ongoing **ORCA-OL** trial, are costly and risky; earlier positive results are not necessarily predictive of future success, and unforeseen adverse events or impurities (e.g., nitrosamines) could delay or prevent approval[209](index=209&type=chunk)[212](index=212&type=chunk)[215](index=215&type=chunk)[216](index=216&type=chunk) - The use or misuse of **cytisinicline** could lead to product liability claims, potentially revoking regulatory approvals or causing substantial financial and reputational harm[221](index=221&type=chunk)[222](index=222&type=chunk) - Business operations may be negatively affected by extreme weather conditions, natural disasters (e.g., earthquakes near **Sopharma's** facilities), and climate change, impacting **cytisinicline** supply[229](index=229&type=chunk)[230](index=230&type=chunk) [Risks Related to Regulatory Approval of Cytisinicline and Other Legal Compliance Matters](index=37&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Cytisinicline%20and%20Other%20Legal%20Compliance%20Matters) - Failure to obtain necessary regulatory approvals from the **FDA** or foreign authorities will prevent the sale of **cytisinicline**[232](index=232&type=chunk) - Disruptions at the **FDA**, including impacts from the **Supreme Court's Chevron doctrine reversal**, government shutdowns, or staffing changes, could slow product review and approval[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk)[239](index=239&type=chunk) - Healthcare legislative and executive reform measures, such as the **Inflation Reduction Act**, could increase costs, limit reimbursement, or reduce demand for **cytisinicline**[240](index=240&type=chunk)[242](index=242&type=chunk) - Even with regulatory approval, the company will face costly ongoing compliance requirements for manufacturing, labeling, promotion, and post-marketing studies, with non-compliance leading to penalties[245](index=245&type=chunk)[248](index=248&type=chunk)[249](index=249&type=chunk) - The company is subject to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws, with potential for substantial penalties for non-compliance[251](index=251&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk) - Misconduct by employees, contractors, or partners, including noncompliance with regulatory standards or improper use of information, could lead to regulatory sanctions and reputational harm[256](index=256&type=chunk) - **Breakthrough Therapy designation** for vaping cessation does not guarantee faster development, regulatory review, or ultimate marketing approval[260](index=260&type=chunk)[261](index=261&type=chunk) [Risks Related to our Business Operations](index=42&type=section&id=Risks%20Related%20to%20our%20Business%20Operations) - The company's limited operating history and sole reliance on **cytisinicline** make it difficult to evaluate its business, predict prospects, and forecast financial performance and growth[262](index=262&type=chunk) - Future success depends on attracting, retaining, and motivating qualified personnel, including key executives; the inability to do so could impede research, development, and commercialization[263](index=263&type=chunk)[264](index=264&type=chunk) - Expanding the organization for potential commercialization of **cytisinicline** may lead to difficulties in managing growth, operational mistakes, and diversion of resources[265](index=265&type=chunk)[266](index=266&type=chunk) - Investing in additional indications for **cytisinicline**, such as e-cigarette cessation, is highly uncertain and may not yield commercially successful products after significant capital investment[267](index=267&type=chunk)[268](index=268&type=chunk) - Internal computer systems or those of third-party collaborators are vulnerable to security breaches and cyber-attacks, which could disrupt development programs, lead to data loss, and incur liabilities[269](index=269&type=chunk)[271](index=271&type=chunk) - Future integration of **AI** tools, either directly or through third parties, introduces legal, regulatory, ethical, and data privacy risks that could adversely impact the business and reputation[272](index=272&type=chunk) [Risks Related to Our Reliance on Third Parties](index=44&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) - The company relies on third parties, including **Sopharma**, to manufacture **cytisinicline**; a dispute with **Sopharma** over engaging alternative manufacturers could delay commercialization or lead to litigation[273](index=273&type=chunk)[275](index=275&type=chunk)[276](index=276&type=chunk) - Manufacturing risks include difficulties in scaling production, quality control, contamination (e.g., nitrosamines), and geopolitical instability (e.g., **Ukraine conflict**) impacting supply from **Sopharma**[279](index=279&type=chunk)[282](index=282&type=chunk) - Reliance on third-party **CROs** for clinical trials means failure to perform or comply with regulatory requirements could delay development or invalidate trial results[284](index=284&type=chunk)[285](index=285&type=chunk) - Inability to establish or maintain third-party collaborations on commercially reasonable terms could adversely affect research, development, and commercialization efforts[286](index=286&type=chunk)[287](index=287&type=chunk) - Contractual indemnification provisions could expose the company to material adverse effects if obligations exceed insurance coverage or collaborators fail to indemnify[288](index=288&type=chunk)[289](index=289&type=chunk) - Reliance on third-party service providers for distribution, warehousing, government price reporting, and adverse event reporting means their failure to perform could impair product delivery and lead to regulatory sanctions[290](index=290&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk)[295](index=295&type=chunk) [Risks Related to Commercialization of Cytisinicline](index=47&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Cytisinicline) - The company lacks a sales and marketing infrastructure and relies on third parties (e.g., **Omnicom partnership**) to commercialize **cytisinicline**, posing risks if these efforts are unsuccessful or delayed[296](index=296&type=chunk)[297](index=297&type=chunk) - The market for new products is highly competitive, with larger competitors possessing greater resources, potentially developing superior or more cost-efficient products[301](index=301&type=chunk)[303](index=303&type=chunk) - Commercial success depends on market acceptance by physicians, patients, and third-party payors, which is uncertain and requires significant investment in education[304](index=304&type=chunk)[305](index=305&type=chunk) - Obtaining adequate reimbursement and insurance coverage for **cytisinicline** is uncertain, and increasing efforts by payors to limit healthcare costs could restrict pricing and profitability[308](index=308&type=chunk)[313](index=313&type=chunk)[314](index=314&type=chunk) - **Sopharma** could breach its supply agreement, selling **cytisinicline** into the company's territories or permitting third-party exports, increasing competition and negatively impacting commercialization[319](index=319&type=chunk) - The illegal distribution and sale of counterfeit **cytisinicline** or unapproved versions by third parties could harm patient safety, the company's reputation, and financial performance[320](index=320&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk) - Inability to form future collaborations for **cytisinicline** on acceptable terms may force the company to alter its development and commercialization plans, requiring additional capital and expertise[325](index=325&type=chunk)[326](index=326&type=chunk) - Efforts to identify, license, discover, develop, or commercialize additional product candidates are uncertain and may fail to yield commercially viable products, adversely affecting the business[327](index=327&type=chunk)[328](index=328&type=chunk) [Risks Related to our Intellectual Property](index=50&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) - Reliance on trade secret protection and confidentiality agreements carries risks of disclosure or independent discovery by competitors, potentially impairing competitive position[332](index=332&type=chunk)[333](index=333&type=chunk) - Third-party claims of intellectual property infringement could prevent or delay development and commercialization efforts, leading to substantial litigation expenses, damages, or the need for licenses[334](index=334&type=chunk)[338](index=338&type=chunk) - Inability to obtain or maintain adequate patent protection for product candidates, or challenges to existing patents, could allow competitors to enter the market[339](index=339&type=chunk)[341](index=341&type=chunk) - Changes in patent law, including recent **U.S. Supreme Court** rulings, could diminish the value of patents, especially for naturally occurring substances like **cytisinicline**[344](index=344&type=chunk)[345](index=345&type=chunk) - Risk of claims that employees, consultants, or independent contractors have wrongfully used or disclosed confidential information or trade secrets of third parties, leading to litigation and potential loss of **IP** rights[346](index=346&type=chunk) - Patents have a limited lifespan, and delays in regulatory approvals could reduce the effective period of patent protection, allowing competitors to launch products earlier[347](index=347&type=chunk)[349](index=349&type=chunk) - Protecting intellectual property rights globally is expensive and challenging, as foreign laws may offer less protection, potentially allowing competitors to use technologies in other jurisdictions[355](index=355&type=chunk)[356](index=356&type=chunk) [Risks Related to Our Common Stock](index=53&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) - The market price for the company's **common stock** is highly volatile, influenced by factors such as clinical trial results, regulatory approvals, and macroeconomic conditions[357](index=357&type=chunk)[360](index=360&type=chunk) - Sales of a substantial number of **common shares**, conversion of **convertible debt**, or exercise of outstanding warrants and options could cause significant dilution and a decline in stock price[359](index=359&type=chunk)[365](index=365&type=chunk) - Future capital raises through equity or debt securities may result in further dilution for existing stockholders or impose restrictive covenants[366](index=366&type=chunk)[368](index=368&type=chunk)[369](index=369&type=chunk) - As a smaller reporting company, reduced disclosure requirements may make the **common stock** less attractive to investors, potentially leading to a less active trading market and increased price volatility[370](index=370&type=chunk) - Lack of or unfavorable research reports from equity analysts could decrease demand for the stock, leading to a decline in stock price and trading volume[371](index=371&type=chunk) [General Risk Factors](index=57&type=section&id=General%20Risk%20Factors) - The company is at risk of securities class action litigation, which could result in substantial costs and diversion of management's attention[372](index=372&type=chunk) - Complying with public company laws and regulations incurs significant legal, accounting, and governance expenses, and challenges in attracting and retaining qualified personnel[373](index=373&type=chunk) - Shareholder activism could disrupt business operations, increase costs, and divert management's attention[374](index=374&type=chunk) - Anti-takeover provisions under **Delaware law** and the company's bylaws could make an acquisition more difficult and limit stockholders' ability to replace management or choose a favorable judicial forum[375](index=375&type=chunk)[376](index=376&type=chunk) - Failure to maintain effective internal control over financial reporting could harm the company's reputation, results of operations, and financial condition[377](index=377&type=chunk)[378](index=378&type=chunk) - Pre-merger **net operating loss carryforwards** and certain other tax attributes are subject to limitations due to an ownership change, potentially impacting cash flow and results of operations[379](index=379&type=chunk) - **U.S. federal tax reform** (e.g., **Tax Cuts and Jobs Act**) and changes in other tax laws could increase the company's tax burden and adversely affect its business and financial condition[381](index=381&type=chunk)[382](index=382&type=chunk)[383](index=383&type=chunk) [Item 6. Exhibits](index=64&type=section&id=Item%206.%20Exhibits) This section lists all documents filed as exhibits to the Form 10-Q, including warrants, an employment agreement, and certifications - **Exhibit 4.1**: Form of Warrant to Purchase Common Stock or Pre-Funded Warrants[385](index=385&type=chunk) - **Exhibit 10.1**: Executive Employment Agreement, dated **May 9, 2025**, by and between **Achieve Life Sciences, Inc.** and **Richard Stewart**[385](index=385&type=chunk) - **Exhibits 31.1** and **31.2**: Certifications of **Chief Executive Officer** and **Chief Financial Officer** pursuant to **Rule 13a-14(a)** or **15d-14(a)** of the **Securities Exchange Act of 1934**[385](index=385&type=chunk) - **Exhibits 32.1** and **32.2**: Certifications of **Chief Executive Officer** and **Chief Financial Officer** pursuant to **18 U.S.C. Section 1350**[385](index=385&type=chunk) - **Exhibits 101.INS**, **101.SCH**, and **104**: Inline **XBRL Instance Document**, **Taxonomy Extension Schema**, and Cover page formatted as Inline **XBRL**[385](index=385&type=chunk) [Signatures](index=65&type=section&id=Signatures) This section contains the formal signatures, certifying the submission of the Quarterly Report on Form 10-Q - The report was signed by **Mark Oki**, **Chief Financial Officer** (**Principal Financial Officer**) of **Achieve Life Sciences, Inc.** on **August 7, 2025**[389](index=389&type=chunk)

[Second Quarter 2025 Overview](index=1&type=section&id=Second%20Quarter%202025%20Overview) [1.1 Executive Summary](index=1&type=section&id=1.1%20Executive%20Summary) Achieve Life Sciences made significant progress in Q2 2025, successfully submitting the cytisinicline NDA, establishing an innovative commercialization partnership, and securing financing to advance its vision for treating nicotine dependence - Achieve Life Sciences achieved significant progress in Q2 2025, including the submission of the cytisinicline NDA, establishment of a commercialization partnership with Omnicom, and securing financing[2](index=2&type=chunk) - If approved, cytisinicline would be the first novel drug therapy for nicotine dependence in nearly two decades[2](index=2&type=chunk) [1.2 Second Quarter Highlights](index=1&type=section&id=1.2%20Second%20Quarter%20Highlights) This quarter, Achieve Life Sciences achieved several key milestones in cytisinicline's regulatory submission, commercialization readiness, financing, and clinical data publication - Submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline as a treatment for adult nicotine dependence for smoking cessation[4](index=4&type=chunk)[5](index=5&type=chunk) - Announced a partnership with Omnicom to develop and execute a fully integrated launch strategy aimed at reducing commercialization costs and accelerating execution[4](index=4&type=chunk)[6](index=6&type=chunk) - Raised **$49.3 million** in gross proceeds through an underwritten public offering to support the continued advancement of cytisinicline[4](index=4&type=chunk)[7](index=7&type=chunk) - Met key requirements in the ORCA-OL long-term exposure trial, including safety exposure data for **≥300 participants** receiving at least six months of cumulative cytisinicline treatment and at least **100 participants** receiving one year of cumulative cytisinicline treatment[4](index=4&type=chunk)[8](index=8&type=chunk) - Announced the publication of Phase 3 ORCA-3 trial results in JAMA Internal Medicine[4](index=4&type=chunk)[9](index=9&type=chunk) [1.2.1 Cytisinicline NDA Submission to FDA](index=1&type=section&id=1.2.1%20Cytisinicline%20NDA%20Submission%20to%20FDA) Achieve Life Sciences submitted the cytisinicline NDA to the FDA in June 2025 for treating nicotine dependence in adults seeking to quit smoking, a major milestone supported by positive ORCA-2, ORCA-3, and ORCA-OL trial results - NDA submission completed in **June 2025**, marking a major milestone after a decade of research[5](index=5&type=chunk) - Submission supported by positive results from Phase 3 ORCA-2 and ORCA-3 trials, which demonstrated significantly higher smoking cessation rates for cytisinicline compared to placebo[5](index=5&type=chunk) - The ORCA-OL study provided favorable long-term safety data, supporting the NDA submission[5](index=5&type=chunk) [1.2.2 Omnicom Partnership for U.S. Launch](index=1&type=section&id=1.2.2%20Omnicom%20Partnership%20for%20U.S.%20Launch) Achieve partnered with Omnicom in June 2025 to develop and execute cytisinicline's commercial launch strategy, aiming for a cost-effective, streamlined, and data-driven path through integrated agencies and an AI-powered platform - The strategic partnership with Omnicom aims for a more cost-effective, streamlined, and insight-driven launch pathway[6](index=6&type=chunk) - The collaboration integrates **seven Omnicom specialty agencies**, forming a unified team covering brand development, medical and patient education, market access, public relations, media, and marketing technology[6](index=6&type=chunk) - Both parties are building a unified, AI-powered launch platform to reduce the time, cost, and risk associated with traditional in-house infrastructure development[6](index=6&type=chunk) [1.2.3 Public Offering of Securities](index=1&type=section&id=1.2.3%20Public%20Offering%20of%20Securities) Achieve completed an underwritten public offering in June 2025, raising **$45 million** in gross proceeds, with an additional **$4.3 million** from overallotment in July, totaling **$49.3 million**, expected to fund cytisinicline development and operations into H2 2026 Public Offering of Securities Details | Metric | Amount/Quantity | | :--------------------------------- | :------------------- | | Initial Public Offering Gross Proceeds | $45 million | | Overallotment Option Additional Proceeds | $4.3 million | | **Total Gross Proceeds** | **$49.3 million** | | Common Shares Issued in Initial Offering | 15 million shares | | Warrants Issued in Initial Offering | 16,766,666 warrants | | Additional Shares Purchased via Overallotment Option | 1,419,896 shares | | Expected Funding Duration | H2 2026 | [1.2.4 ORCA-OL Long-Term Exposure Requirements Met](index=1&type=section&id=1.2.4%20ORCA-OL%20Long-Term%20Exposure%20Requirements%20Met) Achieve met FDA long-term safety requirements for cytisinicline, with over **300 participants** completing at least six months and at least **100 participants** completing one year of cumulative treatment, with data submitted as part of the NDA - Over **300 participants** completed at least six months of cumulative cytisinicline treatment[8](index=8&type=chunk) - At least **100 participants** completed one year of cumulative cytisinicline treatment[8](index=8&type=chunk) - The ORCA-OL clinical study enrolled a total of **479 participants**, with six-month cumulative data submitted as part of the NDA[8](index=8&type=chunk) [1.2.5 ORCA-3 Phase 3 Results Publication](index=1&type=section&id=1.2.5%20ORCA-3%20Phase%203%20Results%20Publication) Phase 3 ORCA-3 trial results published in JAMA Internal Medicine further confirm cytisinicline's potential as a smoking cessation treatment, demonstrating efficacy and tolerability over 6 and 12 weeks in **792 adult smokers** - Phase 3 ORCA-3 trial results published in JAMA Internal Medicine[9](index=9&type=chunk) - This randomized, placebo-controlled study evaluated the efficacy and tolerability of cytisinicline in **792 adult U.S. smokers**[9](index=9&type=chunk) - Study results were consistent with the earlier ORCA-2 trial, supporting cytisinicline's targeted action on nicotine receptors[9](index=9&type=chunk) [Financial Results](index=3&type=section&id=Financial%20Results) [2.1 Q2 2025 Summary Financials](index=3&type=section&id=2.1%20Q2%202025%20Summary%20Financials) As of June 30, 2025, Achieve Life Sciences reported **$55.4 million** in cash, cash equivalents, and marketable securities, with total operating expenses of **$12.6 million** and a net loss of **$12.7 million** for the quarter Q2 and H1 2025 Financial Summary | Metric | As of June 30, 2025 | | :--------------------------------- | :------------------- | | Cash, Cash Equivalents, and Marketable Securities | $55.4 million | | Three Months Total Operating Expenses | $12.6 million | | Six Months Total Operating Expenses | $25.5 million | | Three Months Net Loss | $12.7 million | | Six Months Net Loss | $25.5 million | [2.2 Consolidated Statements of Loss](index=5&type=section&id=2.2%20Consolidated%20Statements%20of%20Loss) Achieve Life Sciences recorded net losses in both Q2 and H1 2025, with significant year-over-year increases in R&D and G&A expenses leading to expanded operating losses Consolidated Statements of Loss (Summary) | Metric (in thousands USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :----------------------- | :------- | :------- | :------- | :------- | | Research and Development Expenses | 6,707 | 5,113 | 13,804 | 7,912 | | General and Administrative Expenses | 5,856 | 3,318 | 11,653 | 6,501 | | **Total Operating Expenses** | **12,563** | **8,431** | **25,457** | **14,413** | | Operating Loss | (12,563) | (8,431) | (25,457) | (14,413) | | Other Income (Expense) | (155) | (30) | (88) | (542) | | **Net Loss** | **(12,718)** | **(8,461)** | **(25,545)** | **(14,955)** | | Basic and Diluted Net Loss Per Share | (0.37) | (0.25) | (0.74) | (0.50) | | Weighted Average Common Shares Outstanding | 34,685,072 | 34,318,709 | 34,685,072 | 29,683,422 | [2.3 Consolidated Balance Sheets](index=5&type=section&id=2.3%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Achieve Life Sciences' cash, cash equivalents, and marketable securities significantly increased to **$55.4 million**, driving total asset growth and a doubling of stockholders' equity due to recent public offering funding Consolidated Balance Sheets (Summary) | Metric (in thousands USD) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------- | :-------------- | | Cash, Cash Equivalents, and Marketable Securities | 55,397 | 34,360 | | Total Assets | 58,935 | 38,633 | | Accounts Payable and Accrued Liabilities | 5,970 | 6,627 | | Stockholders' Equity | 41,668 | 20,899 | | Total Liabilities and Stockholders' Equity | 58,935 | 38,633 | [Company and Product Profile](index=3&type=section&id=Company%20and%20Product%20Profile) [3.1 About Achieve Life Sciences, Inc.](index=3&type=section&id=3.1%20About%20Achieve%20Life%20Sciences%2C%20Inc.) Achieve Life Sciences is a late-stage specialty pharmaceutical company focused on addressing global smoking and nicotine dependence through cytisinicline's development and commercialization, having submitted its NDA to the FDA and completed a Phase 2 study for e-cigarette cessation - Achieve Life Sciences is a late-stage specialty pharmaceutical company dedicated to addressing global smoking and nicotine dependence through cytisinicline[12](index=12&type=chunk) - The company has submitted the cytisinicline NDA to the FDA for treating adult nicotine dependence for smoking cessation, based on two successful Phase 3 studies and an open-label safety study[12](index=12&type=chunk) - The company also completed a Phase 2 study of cytisinicline for e-cigarette cessation and held a successful End-of-Phase 2 meeting with the FDA, aiming for a future e-cigarette indication[12](index=12&type=chunk) [3.2 About Cytisinicline](index=3&type=section&id=3.2%20About%20Cytisinicline) Cytisinicline, a plant-based alkaloid, treats nicotine addiction by interacting with brain nicotine receptors, reducing craving severity and the rewarding effects of nicotine products, and has received FDA Breakthrough Therapy designation for e-cigarette cessation - Approximately **29 million adults** in the U.S. smoke combustible cigarettes, with nearly **500,000 smoking-related deaths** annually[13](index=13&type=chunk) - Approximately **17 million adults** in the U.S. use e-cigarettes, with no FDA-approved treatments specifically for e-cigarette cessation currently available[13](index=13&type=chunk) - Cytisinicline is a plant-based alkaloid that helps treat nicotine addiction by binding to nicotine acetylcholine receptors in the brain, reducing nicotine craving symptoms and the rewarding effects of nicotine products[14](index=14&type=chunk) - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical unmet need in e-cigarette cessation[13](index=13&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) [4.1 Conference Call Details](index=3&type=section&id=4.1%20Conference%20Call%20Details) Achieve Life Sciences held its Q2 earnings conference call on August 7, 2025, offering webcast and dial-in access with replay availability - The conference call was held on **August 7, 2025, at 8:30 AM ET**[11](index=11&type=chunk) - Access was available via webcast or by dialing specified phone numbers (U.S. and Canada: 877-269-7756, International: 201-689-7817, Conference ID: 13754433)[11](index=11&type=chunk) - A webcast replay was available approximately three hours after the call and archived on the website for **90 days**[11](index=11&type=chunk) [4.2 Forward-Looking Statements](index=4&type=section&id=4.2%20Forward-Looking%20Statements) This press release contains forward-looking statements subject to risks, uncertainties, and assumptions that could cause actual results to differ materially, including those related to regulatory approvals, financing, market changes, and intellectual property protection - This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995[16](index=16&type=chunk) - Forward-looking statements involve expectations regarding the use of public offering proceeds, clinical development and regulatory review of cytisinicline, commercialization activities, potential benefits of the Omnicom partnership, market size, and the potential benefits, efficacy, safety, and tolerability of cytisinicline[16](index=16&type=chunk) - Risk factors include cytisinicline potentially not achieving anticipated benefits, inability to obtain additional financing, failure to obtain timely regulatory approval or successful commercialization, new developments in smoking and e-cigarette cessation, inadequate intellectual property protection, and macroeconomic and geopolitical conditions[16](index=16&type=chunk) [4.3 Achieve Contact and References](index=4&type=section&id=4.3%20Achieve%20Contact%20and%20References) This section provides Achieve Life Sciences' investor relations contact information and references for statistical data cited in the press release - Achieve Contact: Nicole Jones, Email: ir@achievelifesciences.com, Phone: 425-686-1510[17](index=17&type=chunk) - References include data sources on U.S. adult smoking cessation, global tobacco epidemic reports, health effects of smoking, and e-cigarette use among U.S. adults and youth[17](index=17&type=chunk)[18](index=18&type=chunk)[20](index=20&type=chunk)