Achieve Life Sciences, Inc. - ACHV STOCK NEWS

Achieve Life Sciences (NASDAQ: ACHV) reported Q3 2024 financial results and provided updates on its cytisinicline development program. Key developments include completed enrollment in the Phase 3 ORCA-OL trial with 479 participants, FDA Breakthrough Therapy designation for vaping cessation, and leadership changes including Richard Stewart as CEO. The company reported cash and investments of $42.9 million, with operating expenses of $12.5 million for Q3 and a net loss of $12.5 million. Achieve plans to submit an NDA in Q2 2025 and is preparing for U.S. market launch with an expanded commercial team.

Achieve Life Sciences (Nasdaq: ACHV), a late-stage pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment, will release its third quarter 2024 financial results and provide a corporate update on November 7, 2024, at 4:30 PM EST. The company will host a conference call and webcast accessible via phone or online streaming. The webcast replay will be available approximately three hours after the call and remain archived on the website for 90 days.

Achieve Life Sciences (Nasdaq: ACHV) announced Dr. Cindy Jacobs' presentation at the FDA and NIH Joint Public Meeting on advancing smoking cessation treatments. Dr. Jacobs highlighted cytisinicline, the only nicotine dependence treatment currently in late-stage development. The company has completed two Phase 3 trials involving over 1,600 subjects, demonstrating safety and efficacy. The new formulation features a streamlined dosing schedule and extended treatment durations, improving upon the complex 25-day regimen of the original cytisine treatment used in Eastern and Central Europe. Achieve is working on completing a longer-term safety exposure study before NDA filing.

Achieve Life Sciences, Inc. (Nasdaq: ACHV) has promoted Jaime Xinos to Chief Commercial Officer, effective immediately. In her expanded role, Ms. Xinos will oversee all commercial operations and lead the company's strategic preparations for the anticipated U.S. launch of cytisinicline, a treatment for nicotine dependence. Her responsibilities include driving readiness across key stakeholders, including patients, healthcare providers, and payors.

Ms. Xinos, who has been with Achieve since 2017, will focus on developing innovative, patient-first, digital strategies and forging strategic partnerships to ensure a successful market entry for cytisinicline upon FDA approval. With nearly 25 years of commercial experience in the biotechnology and pharmaceutical industries, Ms. Xinos is recognized as an inspirational thought leader in translating scientific advancements into business strategies.

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.