Achieve Life Sciences, Inc. (NASDAQ:ACHV) Q2 2024 Earnings Conference Call August 13, 2024 4:30 PM ET Company Participants Nicole Jones - IR John Bencich - CEO Cindy Jacobs - President and Chief Medical Officer Jerry Wan - Principal Accounting Officer Conference Call Participants Thomas Flaten - Lake Street Capital Justin Walsh - JonesTrading John Vandermosten - Zacks Ilya Zubkov - Freedom Broker Thomas Flaten - Lake Street Capital Operator Greetings, and welcome to the Achieve Life Sciences Second Quarter ...

Financial Performance - The net loss for the six months ended June 30, 2024, was $15.0 million, with an accumulated deficit of $180.7 million[110]. - The company has incurred an accumulated deficit of $180.7 million through June 30, 2024, and expects to incur substantial additional losses in the future[147]. - For the six months ended June 30, 2024, net cash used in operating activities decreased to $10.2 million from $15.0 million in the same period of 2023[164]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $56.0 million, significantly higher than $15.3 million in the same period of 2023[165]. - Net cash used in investing activities increased to $46.6 million for the six months ended June 30, 2024, compared to nil in the same period of 2023[166]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $61.3 million, with a positive working capital balance of $48.8 million as of June 30, 2024[110]. - As of June 30, 2024, the company had a cash balance of $61.3 million and a positive working capital of $48.8 million[147]. Research and Development - R&D expenses for the three months ended June 30, 2024, increased to $5.1 million from $4.6 million in the same period in 2023, while expenses for the six months decreased to $7.9 million from $10.1 million[143]. - The company anticipates an increase in R&D expenses as it continues ongoing non-clinical studies and initiates new clinical trials[138]. Clinical Trials and Efficacy - Cytisinicline demonstrated a 74-80% median reduction in the number of cigarettes smoked over a 25-day treatment period, compared to a 62% reduction in placebo arms[118]. - The 3 mg TID cytisinicline arm showed a 50% abstinence rate at week 4, compared to 10% for placebo (p<0.0001)[119]. - The Phase 3 ORCA-2 trial showed that subjects receiving 12 weeks of cytisinicline had a 32.6% abstinence rate compared to 7.0% for placebo (p<0.0001)[125]. - The Phase 2 ORCA-V1 trial reported a vaping cessation rate of 31.8% for cytisinicline compared to 15.1% for placebo (p=0.04)[123]. - The Phase 3 ORCA-3 trial showed that subjects receiving 12 weeks of cytisinicline had 4.4 times higher odds of quitting smoking compared to placebo, with a cessation rate of 30.3% versus 9.4% for placebo[130]. - The continuous smoking cessation rate from week 9 to week 24 was 20.5% for the 12-week cytisinicline arm compared to 4.2% for placebo, with an odds ratio of 5.79[131]. - Cytisinicline is differentiated from existing treatments due to its robust efficacy, minimal side effects, and optional shorter course of therapy[109]. Regulatory and Safety - Cytisinicline received Breakthrough Therapy designation from the FDA for nicotine e-cigarette cessation in Q3 2024[113]. - The FDA indicated that a single open-label study evaluating long-term safety effects of cytisinicline will be sufficient for NDA submission anticipated in the first half of 2025[112]. - The ongoing ORCA-OL trial aims to provide long-term safety exposure data from over 1,700 subjects, with results expected to support NDA submission[114]. Debt and Financing - The company entered into a contingent convertible debt agreement on May 15, 2023, providing term loans with an aggregate original principal amount of $16.6 million, refinancing previous convertible debt[150]. - The New Convertible Term Loan, initiated on July 25, 2024, has an original principal amount of $10.0 million, with additional loans of up to $10.0 million available upon certain events[151]. - The New Convertible Term Loan matures on December 1, 2027, with a potential extension to June 1, 2028, and features an interest rate of at least 7.0%[153]. - The company raised approximately $15.3 million in net proceeds from a registered direct offering of 3,000,000 shares at $5.50 per share in May 2023[161]. - In February 2024, the company raised approximately $56.1 million in net proceeds from a registered direct offering of 13,086,151 shares at $4.585 per share[163]. Accounting and Obligations - The company has contractual obligations and contingencies disclosed in its Annual Report on Form 10-K for the year ended December 31, 2023[167]. - There have been no material changes to the company's critical accounting policies since December 31, 2023[168]. Revenue Generation - The company has not generated any revenue from product sales to date and may not do so in the near future[147].

Financial Performance - Total operating expenses for Q2 2024 were $8.4 million, compared to $7.7 million in Q2 2023, representing an increase of approximately 9%[15] - The net loss for Q2 2024 was $8.5 million, compared to a net loss of $8.2 million in Q2 2023, indicating a year-over-year increase of about 3%[15] - The total net loss for the six months ended June 30, 2024, was $15.0 million, down from $17.2 million for the same period in 2023, reflecting a decrease of approximately 13%[15] - The weighted average number of basic and diluted common shares outstanding was 34,341,303 as of August 13, 2024[8] Cash and Debt Management - Achieve Life Sciences reported total cash, cash equivalents, restricted cash, and short-term investments of $61.3 million as of June 30, 2024[8] - The company refinanced up to $20 million in debt with Silicon Valley Bank, extending the maturity date from August 1, 2024, to December 1, 2027[4] Clinical Trials and Designations - The company initiated the ORCA-OL clinical trial with over half of the 650 participants already enrolled, aiming to support an NDA submission in the first half of 2025[6] - Achieve received FDA Breakthrough Therapy designation for cytisinicline for vaping cessation, which may accelerate the development and review process[2] - Data from the ORCA-V1 trial indicated that cytisinicline more than doubled the likelihood of quitting nicotine e-cigarettes compared to placebo[7] Market Presence - Achieve joined the U.S. Russell 3000® and Russell Microcap® Indexes effective July 1, 2024, enhancing visibility among investors[5]

SEATTLE and VANCOUVER, British Columbia, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage pharmaceutical company dedicated to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced its financial results for the second quarter of 2024 and provided an update on its cytisinicline development program. Recent Highlights The FDA granted Breakthrough Therapy designation for cytisinicline treatment of nic ...

SEATTLE and VANCOUVER, British Columbia, July 31, 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, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for cytisinicline for nicotine e-cigarette, or vaping, cessation. "Since there are no FDA-approved medications specifically in ...

SEATTLE and VANCOUVER, British Columbia, July 29, 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 it has entered into a $20 million debt refinancing agreement with Silicon Valley Bank (SVB), a division of First-Citizens Bank. The new loan agreement refinances the existing debt facility with SVB and SVB Capital ...

Company Overview - Achieve Life Sciences, Inc. is a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline for smoking cessation and nicotine dependence [1][2] - The company will report its second quarter 2024 financial results and provide an update on the cytisinicline development program on August 13, 2024 [1] Industry Context - There are approximately 28 million adults in the United States who smoke combustible cigarettes, with tobacco use being the leading cause of preventable death, resulting in over 8 million deaths globally and nearly 500,000 deaths annually in the U.S. [2] - Smoking and exposure to secondhand smoke are responsible for more than 87% of lung cancer deaths, 61% of pulmonary disease deaths, and 32% of deaths from coronary heart disease [2] - Over 11 million adults in the U.S. use e-cigarettes, with 2.1 million middle and high school students reporting e-cigarette use in 2023 [2] Product Information - Cytisinicline is a plant-based alkaloid that interacts with nicotinic acetylcholine receptors in the brain, aimed at treating nicotine addiction for both smoking and e-cigarette cessation [3] - The product is still investigational and has not received FDA approval for any indication in the United States [3]

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].

Financial Data and Key Metrics Changes - The company secured financing of up to $124 million, which will support the ORCA-OL trial and provide cash runway through NDA submission and approval [6][16] - As of March 31, 2024, cash, cash equivalents, and restricted cash were $66.4 million, with expectations that initial net proceeds will sustain operations into the second half of 2025 [17] - Total operating expenses decreased to $6 million in Q1 2024 from $8.6 million in Q1 2023, with a net loss of $6.5 million compared to $9 million in the same quarter of the previous year [17] Business Line Data and Key Metrics Changes - The ORCA-V1 trial results showed that cytisinicline more than doubled the odds of quitting e-cigarettes compared to placebo, with 31.8% of treated participants achieving continuous vaping abstinence [8] - The ORCA-OL study is set to begin enrollment soon, focusing on long-term safety data collection for cytisinicline [11][12] Market Data and Key Metrics Changes - The prevalence of vaping is increasing, with an estimated 11 million adults and 2 million middle and high school students using e-cigarettes in the U.S. [8] - More than half of adults who vape have reported interest in quitting, highlighting a significant market opportunity for cytisinicline [8] Company Strategy and Development Direction - The company plans to conduct an end-of-Phase 2 meeting with the FDA later this year to discuss clinical requirements for label expansion for vaping cessation [9] - The focus for 2024 includes the initiation and completion of enrollment for the ORCA-OL study and preparations for NDA submission for smoking cessation [22] Management's Comments on Operating Environment and Future Outlook - Management emphasized the urgent need for effective cessation treatments, noting that there have been no new approved smoking cessation agents in nearly 20 years [21] - The company believes cytisinicline can play a critical role in addressing the public health crisis of nicotine dependence and improving long-term patient outcomes [21] Other Important Information - The company presented survey results indicating that over 80% of participants treated with cytisinicline were willing to recommend it to others, with 69% successfully quitting smoking [10] - The FDA has agreed on the number of subjects required for long-term exposure data necessary for NDA filing, which is critical for the timing of the submission [6][12] Q&A Session Summary Question: Status of the 29 sites for ORCA-OL study - All sites are finishing up their contracts and will be ready to enroll within the next few weeks [25] Question: Clarification on the 1,100 subjects contacted - About 25% of the 1,700 subjects were smoke or vape free, and approximately two-thirds of those contacted are interested in participating [26][28] Question: Expected re-entry of subjects into the study - The screening process will determine how many of the contacted subjects will re-enter the study, but the screening failure rate is not expected to be high [33] Question: Handling of placebo patients in ORCA-OL - There will be no placebo patients in the open-label study; prior placebo subjects will be treated with cytisinicline for the first time [35] Question: Long-term safety data for e-cigarette cessation - The FDA indicated that the current open-label trial will suffice for both smoking and vaping indications, eliminating the need for a separate long-term exposure trial for vaping [57]