Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Achieve Life Sciences Inc (ACHV, Financial) received FDA Breakthrough Therapy designation for cytisinicline for treating e-cigarette or vaping nicotine dependence.
- The company initiated and gained significant traction on the ORCA-OL trial evaluating the long-term safety effects of cytisinicline.
- Achieve Life Sciences Inc (ACHV) was added to the US Russell 3000 and Russell Microcap Indexes.
- The company successfully refinanced its outstanding debt agreement with Silicon Valley Bank, extending the maturity date and lowering the cost of capital.
- Enrollment for the ORCA-OL trial is progressing well, with more than half of the proposed 650 participants already enrolled.
Negative Points
- Achieve Life Sciences Inc (ACHV) reported a net loss of $8.5 million for the quarter ended June 30, 2024.
- The company's cash balance decreased from $66.4 million to $61.3 million over the last quarter.
- Quarterly operating expenses are expected to increase as the ORCA-OL trial progresses.
- There are no FDA-approved treatments for e-cigarette cessation, indicating a challenging regulatory landscape.
- The company faces the risk of high treatment discontinuation rates, which could impact the success of the ORCA-OL trial.
Q & A Highlights
Q: Cindy, you mentioned the retention rate in your prepared comments. Can you share what that is? And can we infer from your comments that enrollment pace is accelerating?
A: The enrollment started off in an accelerated manner. We don't give exact numbers, but given that we have over half of the intended 650 participants, it shows how well enrollment has gone. The most important thing now is monitoring the discontinuation rate, which is currently in single digits. If it remains low, we may close enrollment early to save costs.
Q: Once you have the 300 patients with six months of data, are there any other gating items for completing the NDA package?
A: That is the last piece for the clinical regulatory requirements for the NDA. After reaching six months, we need to monitor the data, lock the database, and write it up. This data will then be integrated into the NDA submission documents.
Q: Can you expand on the potential advantages of having vaping cessation specifically on your label versus broader labels focused more generally on nicotine?
A: The core indication will be smoking cessation for nicotine dependence, but having a specific vaping cessation label would be powerful due to the size of the vaping market. There are approximately 28 million adult smokers in the US and 11 million vapers. Being the first and likely only treatment for vaping cessation would be very impactful.
Q: Can you provide any color on potential discussion points leading into your end of Phase II meeting with the FDA?
A: The meeting will focus on ensuring that only one Phase III trial is needed, given the Phase II trial as a supporting trial. We will also discuss any additional safety data requirements. This will help us get clarity and agreement on what is required, allowing us to advance to the supplemental NDA faster.
Q: Regarding the open-label ORCA trial, will you be looking at any efficacy in this trial?
A: Yes, we will be looking at efficacy, especially for retreatment of individuals previously treated with cytisinicline and those originally on placebo. However, since it is not a randomized study, it is unlikely this data will be included in the label, but it will be published.
Q: What is your screening success rate for the OL trial? Have you been able to enroll patients from the 12-week cytisinicline exposure?
A: The screen fail rate has been half or lower than usual, as most participants had already screened through previous ORCA studies. Two-thirds of the individuals in the open-label trial had already been treated with cytisinicline, which helps us reach the six-month and one-year marks sooner.
Q: How do you see the Breakthrough Therapy designation helping you?
A: The designation will help by accelerating agreement on the Phase III clinical trial design, negotiating a rolling submission, and potentially receiving priority review. This will expedite the development process.
Q: Are there any activities from the FDA, NIH, or other government agencies that may support your development in the vaping indication?
A: We expect more support, especially from the FDA through the Breakthrough designation. We will also continue to seek additional support from NIH and NIDA. There is little activity in the vaping cessation space, so advancing our program quickly can make a significant impact.
Q: Given the swift recruitment of trial participants, do you plan to publish any interim results from the ORCA-OL trial this year?
A: We will provide updates following the Data Safety Monitoring Committee reviews, but we do not plan to publish interim results.
Q: Are you considering targeting adolescents in the e-cigarettes study?
A: Initially, we will focus on young adults aged 18 and older. A future potential adolescent program may be considered in a post-marketing setting.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
