Contradictions Unveiled: Achieve's Q2 2025 Earnings Call Highlights FDA Review, Launch Timelines, and Pricing Strategy

Regulatory Milestones:
- Achieve Life Sciences successfully submitted their new drug application for cytisinicline as a treatment for nicotine dependence to the FDA.
- This submission marks a significant regulatory milestone in the development process and initiates the review timeline.
- The submission was driven by years of research and clinical trial data supporting the efficacy and safety profile of cytisinicline.

Commercial Partnerships:
- Achieve Life Sciences partnered with Omnicom, a global leader in health care marketing and technology, to support their commercial launch strategy.
- This collaboration will leverage Omnicom's expertise in launching over 100 product launches in the last three years, enhancing Achieve's ability to execute its commercial strategy effectively.
- The partnership aims to efficiently drive patient engagement and physician awareness for cytisinicline.

Fundraising and Financial Strengthening:
- Achieve Life Sciences raised $49 million in capital through a public offering, strengthening their financial position.
- As of June 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $55.4 million.
- This funding will support operations into the second half of 2026 and facilitate regulatory and early commercial initiatives.

Clinical Trial Success:
- The company has completed the ORCA-OL trial, with over 290 participants achieving one year of cumulative cytisinicline treatment.
- Significant milestones include exceeding 100 participants with one year of exposure, meeting FDA's safety exposure data requirements.
- This accomplishment was crucial for the NDA submission and supports the long-term safety profile of cytisinicline.