SEATTLE and VANCOUVER, British Columbia, July 09, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that Achieve management will be attending the JonesHealthcare Seaside Summit 2024 being held July 14-16, 2024, in Encinitas, CA. John Bencich, CEO of Achieve, will present on Monday, July 15, 2024, at 8:45 AM PDT. Follo ...

Core Insights - Achieve Life Sciences, Inc. announced the presentation of Phase 2 ORCA-V1 trial data for cytisinicline, which showed that treatment more than doubled the likelihood of quitting vaping compared to placebo [1][2]. Company Overview - Achieve Life Sciences is focused on the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence [1][4]. - The company aims to address the smoking health crisis, with an estimated 28 million adults in the U.S. smoking combustible cigarettes and over 11 million using e-cigarettes [4]. Clinical Trial Details - The ORCA-V1 trial involved 160 daily e-cigarette users across five clinical trial locations in the U.S. Participants received 3 mg of cytisinicline three times daily or a placebo for 12 weeks, alongside standard cessation behavioral support [3]. - The trial was supported by the National Institute on Drug Abuse (NIDA) with grant funding totaling $2.8 million [3]. Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, potentially reducing withdrawal symptoms and the satisfaction associated with nicotine products [5]. - Currently, there are no FDA-approved treatments specifically for nicotine e-cigarette cessation, highlighting a significant market opportunity for cytisinicline [4].

Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q1 2024 Earnings Conference Call May 9, 2024 4:30 PM ET Company Participants Nicole Jones - Investor Relations John Bencich - Chief Executive Officer Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Michael Higgins - Ladenburg Thalmann John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Operator Greetings. Welcome to Achieve Life Sciences’ First Quarter 202 ...

Part I. Financial Information [Consolidated Financial Statements](index=7&type=section&id=Item%201.%20Consolidated%20Financial%20Statements) The company reported a net loss of $6.5 million for Q1 2024, an improvement from the prior year, with a February 2024 financing boosting cash to $66.4 million and turning stockholders' equity positive Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $66,398 | $15,546 | | Total current assets | $67,709 | $16,982 | | Total assets | $70,029 | $19,371 | | Convertible debt | $17,141 | $16,662 | | Total liabilities | $20,573 | $20,819 | | Total stockholders' equity | $49,456 | $(1,448) | Consolidated Statement of Loss (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Research and development expense | $2,799 | $5,534 | | General and administrative expense | $3,183 | $3,044 | | Total operating expenses | $5,982 | $8,578 | | Net loss | $(6,494) | $(8,992) | | Net loss per share (basic & diluted) | $(0.26) | $(0.50) | Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,288) | $(8,303) | | Net cash provided by financing activities | $56,110 | $47 | | Net increase/(decrease) in cash | $50,822 | $(8,257) | - In February 2024, the company completed a registered direct offering and concurrent private placement, selling **13,086,151 shares** of common stock and issuing warrants, resulting in net proceeds of approximately **$56.1 million**[61](index=61&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) - The company has a contingent convertible debt agreement with a principal amount of **$15.0 million**, maturing on December 22, 2024, but potentially accelerating to August 1, 2024, if an NDA for cytisinicline is not accepted by the FDA by certain deadlines[51](index=51&type=chunk)[52](index=52&type=chunk)[56](index=56&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on cytisinicline development, with an NDA submission now anticipated in the first half of 2025 following an agreement with the FDA for a single open-label safety study, while a February 2024 financing significantly enhanced liquidity to fund operations into the second half of 2025, despite potential early convertible debt maturity - The company reached an agreement with the FDA that a single, open-label study (ORCA-OL) evaluating long-term safety will be sufficient to complete requirements for an NDA submission, now anticipated in the **first half of 2025**[105](index=105&type=chunk) - The planned ORCA-OL trial will initiate in **Q2 2024**, enrolling up to **650 subjects** who previously participated in ORCA-program studies to gather long-term safety data for up to one year[106](index=106&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Q1 2024 | Q1 2023 | Change Driver | | :--- | :--- | :--- | :--- | | Research & Development | $2,799 | $5,534 | Decrease due to completion of Phase 3 ORCA-3 and Phase 2 ORCA-V1 trials in 2023 | | General & Administrative | $3,183 | $3,044 | Increase due to higher stock-based compensation and consulting costs | - As of March 31, 2024, the company had **$66.4 million** in cash and cash equivalents, which management believes are sufficient to support operating expenses and capital expenditures into the **second half of 2025**[138](index=138&type=chunk) - The company's convertible term loan is expected to mature on **August 1, 2024**, due to the revised NDA submission timeline, unless a waiver or renegotiation is secured, with the company exploring alternative financing options[142](index=142&type=chunk) [Controls and Procedures](index=49&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal control over financial reporting during the quarter - Management, including the principal executive and financial officers, concluded that the company's disclosure controls and procedures were **effective** as of the end of the period covered by the report[156](index=156&type=chunk) - No changes were made to the company's internal control over financial reporting during the quarter ended March 31, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[157](index=157&type=chunk) Part II. Other Information [Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial risks including substantial debt with an accelerated maturity and the need for additional financing, alongside operational dependencies on its sole product candidate, cytisinicline, and a single supplier, Sopharma, compounded by regulatory uncertainties, supply chain vulnerabilities, and intellectual property limitations - **Financial Risk:** The company has substantial debt, and its convertible term loan is expected to mature on **August 1, 2024**, due to the revised NDA submission timeline, unless a waiver or new terms are negotiated, with failure to service this debt potentially leading to default[165](index=165&type=chunk) - **Operational Dependency:** The company's success is entirely dependent on its sole product candidate, cytisinicline, and it relies on a single company, Sopharma in Bulgaria, for its manufacture and supply[176](index=176&type=chunk)[178](index=178&type=chunk) - **Regulatory Risk:** The FDA has advised that long-term safety data is needed for an NDA submission, and while an agreement on the ORCA-OL trial has been reached, there is no guarantee the data will be sufficient for approval or that the FDA won't require additional studies[179](index=179&type=chunk)[182](index=182&type=chunk) - **Supply Chain Risk:** Cytisinicline is derived from plants that grow in limited locations outside the U.S., with the supply exclusively from Sopharma in Bulgaria, and any disruption, including from regional geopolitical instability, could adversely affect the business[184](index=184&type=chunk)[185](index=185&type=chunk) - **Intellectual Property Risk:** Cytisinicline is a naturally occurring substance and is not patentable in the U.S., meaning the company relies on patents for novel formulations and trade secrets, which may not provide sufficient protection against competitors[269](index=269&type=chunk)[300](index=300&type=chunk) - **Commercialization Risk:** The company faces substantial competition from major pharmaceutical companies with greater resources, and the commercial success of cytisinicline will depend on market acceptance and securing adequate reimbursement from third-party payors[257](index=257&type=chunk)[261](index=261&type=chunk) [Exhibits](index=107&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Form of Common Stock Purchase Warrant, the associated Securities Purchase Agreement from the February 2024 Private Placement, and certifications from the Chief Executive Officer

[Corporate Update and Q1 2024 Highlights](index=1&type=section&id=Corporate%20Update%20and%20Q1%202024%20Highlights) This section details significant progress in the cytisinicline clinical program and successful equity financing activities [Clinical Program Advancements](index=1&type=section&id=Clinical%20Program%20Advancements) 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](index=2&type=chunk) - 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](index=3&type=chunk)[4](index=4&type=chunk) - 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](index=2&type=chunk)[5](index=5&type=chunk) [Financing Activities](index=2&type=section&id=Financing%20Activities) 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](index=2&type=chunk)[6](index=6&type=chunk) - 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](index=6&type=chunk) - The total proceeds are expected to fund the development of cytisinicline into **2026** and through potential FDA approval[6](index=6&type=chunk) [Financial Results for First Quarter 2024](index=2&type=section&id=Financial%20Results%20for%20First%20Quarter%202024) This section provides an overview of the company's financial performance for Q1 2024, including key metrics and consolidated statements [Summary of Financial Performance](index=2&type=section&id=Summary%20of%20Financial%20Performance) 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](index=5&type=section&id=Consolidated%20Financial%20Statements) 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](index=2&type=section&id=About%20Achieve%20and%20Cytisinicline) 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](index=2&type=section&id=Market%20Opportunity%20and%20Product%20Information) 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](index=9&type=chunk)[10](index=10&type=chunk) - Tobacco use is the leading cause of preventable death, responsible for nearly **half a million** deaths annually in the U.S[10](index=10&type=chunk) - 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](index=11&type=chunk) [Other Information](index=2&type=section&id=Other%20Information) This section provides details on the Q1 2024 conference call and important disclaimers regarding forward-looking statements [Conference Call Details](index=2&type=section&id=Conference%20Call%20Details) 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](index=8&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=12&type=chunk) - 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](index=12&type=chunk)

Phase 2 ORCA-V1 trial showed treatment with cytisinicline more than doubled odds of quitting e-cigarettes compared with placebo   Cytisinicline treatment well tolerated with no serious adverse events reported and excellent compliance to study treatment Achieve expects to conduct an End-of-Phase 2 Meeting with the FDA later this year to discuss Phase 3 trial plans SEATTLE and VANCOUVER, British Columbia, May 06, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage pharmaceutical c ...

Phira Phonruewiangphing/iStock via Getty Images Achieve Life Sciences (NASDAQ:ACHV) went public via a shell company in 2017 to commercialize the smoking cessation drug Cytisinicline. Cytisinicline is derived from a plant-based compound and has a long history of use in Eastern Europe, but had not been tested in the U.S. Achieve’s central task is to usher the drug through clinical trials and the FDA approval process. Phase 3 trials are done. The company must complete a long-term safety trial before submit ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 033-80623 Achieve Life Sciences, Inc. (Exact name of the registrant as specified in its charter) Delaware 95-4343413 (State or other jurisdiction of (I.R.S. Employer incorporation ...

EXHIBIT 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this “Agreement”) is dated as of February 28, 2024, between Achieve Life Sciences, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to (i) an effective registration statement under the Securities ...

SEATTLE and VANCOUVER, British Columbia, March 20, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ:ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that three oral presentations featuring data from both of the Phase 3 ORCA-2 and ORCA-3 clinical trials of cytisinicline for smoking cessation and from the Phase 2 ORCA-V1 trial for e-cigarette cessation will be present ...