Achieve Life Sciences Inc Stock Price, News & Analysis

Achieve Life Sciences, Inc. (Nasdaq: ACHV) has appointed Dr. Mark L. Rubinstein as its new Head of Medical Affairs. Dr. Rubinstein brings over 20 years of experience in clinical medicine, scientific research, and medical affairs leadership, with a focus on preventative medicine and nicotine cessation. His expertise aligns with Achieve's mission to provide innovative solutions for nicotine dependence.

Dr. Rubinstein previously served as Head of Medical Affairs at Blip and Vice President of Global Scientific Affairs at Juul Labs. He is Professor Emeritus of Pediatrics at the University of California, San Francisco (UCSF), where he conducted NIH-funded research on nicotine addiction in adolescents and smoking cessation interventions. Dr. Rubinstein's appointment comes as Achieve moves closer to anticipated FDA approval and commercialization of cytisinicline, potentially the first new treatment for nicotine dependence in nearly 20 years.

Achieve Life Sciences, Inc. (Nasdaq: ACHV) announced significant changes in its executive leadership and Board of Directors. Richard Stewart, co-founder and current Executive Chairman, will reassume the role of Chief Executive Officer, replacing John Bencich, who served as CEO for the past four years. Thomas King, currently the lead independent director, will assume the role of Executive Chairman.

The leadership change is aimed at bringing in a CEO with substantial M&A and commercial experience to drive the company towards critical milestones, including potential licensing or strategic transactions for the commercialization of cytisinicline, their smoking cessation and nicotine dependence treatment. Achieve remains on track to meet its objectives, including completing enrollment for the ORCA-OL study, meeting with the FDA for an End-of-Phase 2 meeting for vaping cessation, and progressing towards an NDA submission expected in the first half of 2025.

Achieve Life Sciences (NASDAQ: ACHV) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:

1. FDA granted Breakthrough Therapy designation for cytisinicline for vaping cessation
2. Completed refinancing with Silicon Valley Bank, extending loan maturity to December 2027
3. Joined Russell 3000® and Russell Microcap® Indexes
4. Initiated ORCA-OL trial for long-term cytisinicline exposure
5. Presented ORCA-V1 vaping cessation data at SGIM Annual Meeting

Financial results: Cash position of $61.3 million as of June 30, 2024. Q2 operating expenses were $8.4 million with a net loss of $8.5 million. The company expects to file an NDA for cytisinicline in H1 2025.

Achieve Life Sciences (Nasdaq: ACHV) has received FDA Breakthrough Therapy Designation for cytisinicline, a potential first-in-class treatment for nicotine e-cigarette and vaping cessation. This designation is based on the Phase 2 ORCA-V1 trial results, which showed that cytisinicline more than doubled the odds of quitting e-cigarettes compared to placebo. The trial, published in JAMA Internal Medicine, involved 160 adults and demonstrated that participants treated with cytisinicline were 2.6 times more likely to quit vaping. The treatment was well-tolerated with no serious adverse events reported. Achieve plans to hold an End-of-Phase 2 meeting with the FDA before year-end to expedite development and review of cytisinicline for this serious condition affecting over 13 million people in the US.

Achieve Life Sciences (Nasdaq: ACHV) has secured a $20 million debt refinancing agreement with Silicon Valley Bank (SVB). This deal refinances existing debt and extends the maturity date to December 1, 2027. The loan is structured in three tranches: $10 million at closing, $5 million upon FDA acceptance of the New Drug Application for cytisinicline, and $5 million at SVB's discretion. Key terms include:

- Interest rate: Greater of 7.0% or prime rate minus 1.0%
- Interest-only period through December 31, 2025
- Option to convert debt to common stock at $7.00 per share
- Potential six-month extension based on milestones

This refinancing aims to lower capital costs, extend cash runway, and support cytisinicline's regulatory approval process.

Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company focused on developing cytisinicline for smoking cessation and nicotine dependence, has announced it will report its second quarter 2024 financial results on August 13, 2024, at 4:30 PM EDT. The company will also provide an update on the cytisinicline development program during the call.

Investors and interested parties can access the webcast through a provided link or join the live conference call by dialing specific numbers for U.S. & Canada or International callers. The conference ID is 13747337. A replay of the webcast will be available approximately three hours after the call and will be archived on the company's website for 90 days.

Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company specializing in cytisinicline for smoking cessation and nicotine dependence, announced its participation in the JonesHealthcare Seaside Summit 2024. The event will take place from July 14-16, 2024, in Encinitas, CA. CEO John Bencich is scheduled to present on July 15, 2024, at 8:45 AM PDT. Following his presentation, Bencich will join a live panel discussion, "Introducing Disruptive Products to Established Healthcare Markets—Commercial and Regulatory Considerations," at 10:00 AM PDT, moderated by Justin Walsh, PhD, Healthcare Research Analyst at JonesTrading Institutional Services. For more information or to arrange one-on-one meetings, contact JonesTrading or visit Achieve Life Sciences' Investor Relations website.

Achieve Life Sciences (Nasdaq: ACHV) has been added to the U.S. Russell 3000® and Russell Microcap® Indexes, effective July 1, 2024. CEO John Bencich highlighted this as a step to enhance the company's visibility among investors, reflecting solid business fundamentals and market potential for cytisinicline, their treatment for nicotine dependence. Achieve plans to submit a new drug application for smoking cessation in the U.S. in the first half of 2025.

Additionally, Achieve has entered a non-binding term sheet with Silicon Valley Bank to refinance and extend the maturity date of its outstanding term loans. This facility could provide up to $20 million, with interest-only payments through December 31, 2025, maturing on June 1, 2028. The parties expect to close the refinanced loan by August 1, 2024, but there is no guarantee of a definitive agreement.

Achieve Life Sciences has initiated the ORCA-OL clinical trial to evaluate the long-term safety of cytisinicline, a treatment for smoking and nicotine dependence. The open-label trial involves 29 U.S. sites and aims to collect data required for a New Drug Application (NDA) submission expected in the first half of 2025. The study will focus on adults who smoke or use nicotine e-cigarettes, engaging prior ORCA trial participants. It will collect long-term safety data from at least 300 subjects over six months and 100 subjects over one year. Achieve aims to address the FDA's lack of approved treatments for vaping cessation.