Achieve Life Sciences(ACHV) - 2024 Q1 - Quarterly Results

Corporate Update and Q1 2024 Highlights This section details significant progress in the cytisinicline clinical program and successful equity financing activities Clinical Program Advancements Significant progress in the cytisinicline clinical program includes positive Phase 2 trial publication, advancement of the ORCA-OL safety trial, and presentation of key data at the SRNT conference - The Phase 2 ORCA-V1 trial results for cytisinicline as a vaping cessation treatment were published in the Journal of the American Medical Association Internal Medicine (JAMA IM), showing the treatment more than doubled the odds of abstinence[2] - The company plans to initiate the ORCA-OL open-label trial in May 2024 to gather long-term safety data, which is required for the New Drug Application (NDA) submission, now anticipated in the first half of 2025[3][4] - Data from Phase 3 (ORCA-2, ORCA-3) and Phase 2 (ORCA-V1) trials were presented at the SRNT Annual Meeting, where a survey of Phase 3 participants showed 69% who received cytisinicline successfully quit smoking[2][5] Financing Activities Achieve secured up to $124.2 million in gross proceeds through an equity financing deal in February 2024, expected to fund operations into 2026 and through potential FDA approval - An equity financing deal was announced in February 2024 to raise up to approximately $124.2 million in gross proceeds[2][6] - The financing included an initial upfront funding of $60.0 million, with an additional $64.2 million available upon the exercise of milestone-driven warrants[6] - The total proceeds are expected to fund the development of cytisinicline into 2026 and through potential FDA approval[6] Financial Results for First Quarter 2024 This section provides an overview of the company's financial performance for Q1 2024, including key metrics and consolidated statements Summary of Financial Performance As of March 31, 2024, the company reported cash of $66.4 million, a net loss of $6.5 million, and total operating expenses of $6.0 million for the first quarter Q1 2024 Financial Highlights | Metric | Value | | :--- | :--- | | Cash, Cash Equivalents, and Restricted Cash | $66.4 million | | Total Operating Expenses | $6.0 million | | Net Loss | $6.5 million | | Shares Outstanding (as of May 9, 2024) | 34,341,303 | Consolidated Financial Statements The company's net loss improved to $6.5 million in Q1 2024, driven by reduced R&D expenses, with total assets significantly increasing to $70.0 million due to recent financing Consolidated Statements of Loss (in thousands, except per share data) | | Three months ended March 31, | | :--- | :---: | :---: | | | 2024 | 2023 | | Research and development | $2,799 | $5,534 | | General and administrative | $3,183 | $3,044 | | Total operating expenses | $5,982 | $8,578 | | Net loss | $(6,494) | $(8,992) | | Basic and diluted net loss per share | $(0.26) | $(0.50) | Consolidated Balance Sheets (in thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :---: | :---: | | Assets | | | | Cash and cash equivalents | $66,398 | $15,546 | | Total assets | $70,029 | $19,371 | | Liabilities and Stockholders' Equity | | | | Total liabilities | $20,573 | $20,819 | | Stockholders' equity | $49,456 | $(1,448) | | Total liabilities and stockholders' equity | $70,029 | $19,371 | About Achieve and Cytisinicline This section outlines the significant market opportunity for cytisinicline and provides details on its mechanism of action as an investigational product Market Opportunity and Product Information Achieve targets a substantial U.S. market of over 39 million adult nicotine users with cytisinicline, an investigational plant-based alkaloid designed to aid in nicotine cessation - The company is targeting a large market, with an estimated 28 million adult smokers and over 11 million adult e-cigarette users in the United States[9][10] - Tobacco use is the leading cause of preventable death, responsible for nearly half a million deaths annually in the U.S[10] - Cytisinicline is a plant-based alkaloid that interacts with nicotine receptors in the brain to reduce withdrawal symptoms and the rewarding effects of nicotine, and is currently an investigational product not yet approved by the FDA[11] Other Information This section provides details on the Q1 2024 conference call and important disclaimers regarding forward-looking statements Conference Call Details The company hosted a conference call and webcast on May 9, 2024, to discuss Q1 2024 financial results and corporate updates, with a replay available online - A conference call was held on Thursday, May 9, 2024, at 4:30 PM EDT to discuss the financial results and provide a corporate update[8] Forward-Looking Statements This report contains forward-looking statements regarding cytisinicline's development and commercialization, which are subject to various risks and uncertainties - The report contains forward-looking statements regarding cytisinicline's clinical development, potential benefits, market size, and regulatory approval timeline[12] - These statements are subject to risks and uncertainties, including the possibility that cytisinicline may not demonstrate expected benefits, receive regulatory approval, or that the company may not secure necessary financing[12]