Achieve Life Sciences(ACHV) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Overview 1.1 Executive Summary 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] - If approved, cytisinicline would be the first novel drug therapy for nicotine dependence in nearly two decades[2] 1.2 Second Quarter Highlights 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][5] - Announced a partnership with Omnicom to develop and execute a fully integrated launch strategy aimed at reducing commercialization costs and accelerating execution[4][6] - Raised $49.3 million in gross proceeds through an underwritten public offering to support the continued advancement of cytisinicline[4][7] - 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][8] - Announced the publication of Phase 3 ORCA-3 trial results in JAMA Internal Medicine[4][9] 1.2.1 Cytisinicline NDA Submission to FDA 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] - 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] - The ORCA-OL study provided favorable long-term safety data, supporting the NDA submission[5] 1.2.2 Omnicom Partnership for U.S. Launch 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] - 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] - 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] 1.2.3 Public Offering of Securities 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 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] - At least 100 participants completed one year of cumulative cytisinicline treatment[8] - The ORCA-OL clinical study enrolled a total of 479 participants, with six-month cumulative data submitted as part of the NDA[8] 1.2.5 ORCA-3 Phase 3 Results Publication 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] - This randomized, placebo-controlled study evaluated the efficacy and tolerability of cytisinicline in 792 adult U.S. smokers[9] - Study results were consistent with the earlier ORCA-2 trial, supporting cytisinicline's targeted action on nicotine receptors[9] Financial Results 2.1 Q2 2025 Summary Financials 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 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 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 3.1 About Achieve Life Sciences, Inc. 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] - 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] - 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] 3.2 About Cytisinicline 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] - Approximately 17 million adults in the U.S. use e-cigarettes, with no FDA-approved treatments specifically for e-cigarette cessation currently available[13] - 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] - Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical unmet need in e-cigarette cessation[13] Corporate Information 4.1 Conference Call Details 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] - 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] - A webcast replay was available approximately three hours after the call and archived on the website for 90 days[11] 4.2 Forward-Looking Statements 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] - 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] - 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] 4.3 Achieve Contact and References 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] - 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][18][20]