October 22, 2020
Dear Fellow Shareholders,
We hope this letter finds you and your families safe and healthy. Given that we continue to live in unprecedented times, faced with uncertainty and unique challenges, John and I thought it was appropriate to reach out with an update on the company’s progress.
Achieve remains committed to prioritizing the health and safety of our patients, health care providers, and employees. Like many of you, we have adjusted how we conduct business. Our teams continue to work remotely, we have restricted all non-essential travel, and we have implemented numerous safeguards for employees and stakeholders. This commitment extends to participants in our upcoming trials to mitigate against the potential impact of COVID-19. While this is not business as usual, we continue to make excellent progress advancing cytisinicline towards U.S. market approval.
On the corporate development front, we recently announced management changes that included internal promotions of two key executives. These changes have been planned for a long time and were expedited in part by the pandemic, which has restricted international travel for Rick Stewart and Dr. Anthony Clarke, co-founders of Achieve, who are both based in the United Kingdom.
The appointment of John Bencich as Chief Executive Officer and Dr. Cindy Jacobs as President and Chief Medical Officer reflects their contributions to the success of the company thus far. Rick Stewart will continue to serve as the Executive Chairman of the Board of Directors. Additionally, Rick will continue providing his expertise and leadership on strategic initiatives for the company, such as potential commercial partnering and registration of cytisinicline in European markets.
Over the last three years as Achieve’s Chief Financial and Operating Officer, John has led the financing activities which provided the capital to complete the successful Phase 2 ORCA-1 trial last year, and more recently, the funding to allow us to initiate the Phase 3 ORCA-2 trial. John has consistently demonstrated his leadership capabilities across all aspects of the business and has been instrumental in ensuring that Achieve continues to execute on its key objectives.
Under her stewardship, Dr. Cindy Jacobs has led the clinical development team at Achieve and has been responsible for the successful ORCA-1 Phase 2b trial and the planning and execution of the ORCA-2 Phase 3 trial that recently commenced.
While our leadership has realigned, our management team remains steadfast in our mission and in our conviction that cytisinicline has great promise to change the lives of millions of smokers.
In this regard, we are pleased to have recently announced the start of the Phase 3 ORCA-2 trial that we expect will enroll 750 smokers at 15 clinical trial locations throughout the United States. ORCA-2 is the first randomized, double-blind Phase 3 trial evaluating a new therapy for smoking cessation in over a decade. ORCA-2 is designed to evaluate the efficacy and safety of 3 mg cytisinicline given three times daily for 6 and 12-weeks compared to placebo. Importantly, the study will be considered successful if either or both of the arms show an efficacy benefit.
As a reminder, the Phase 2b ORCA-1 trial that we conducted in 250 U.S. smokers showed robust efficacy and a well-tolerated safety profile for cytisinicline, providing important insights to help us to optimize the design of the Phase 3 trial. In ORCA-2, we will evaluate the higher 3 mg dose for a longer treatment duration and utilize the simplified three times daily dosing regimen. We believe these modifications could lead to potentially increased quit rates and more durable efficacy results.
The confidence that we have in cytisinicline’s ability to help smokers quit comes not only from our own studies but from numerous clinical trials that have evaluated more than 10,000 smokers and have been conducted by external experts in the field of smoking cessation.
Most recently, the results of the “RAUORA” trial that compared cytisinicline to Chantix®, the market leader in smoking cessation, were presented at the Society for Research on Nicotine and Tobacco (SRNT) Annual European Meeting. This was the first-ever head-to-head study comparing these two treatments and enrolled a total of 679 smokers. The trial met its primary endpoint of showing that cytisiniclin