Achieve Life Sciences Reaches Agreement with the FDA on Long-Term Cytisinicline Exposure Data Requirements for NDA Submission - Seite 2

“We anticipate that data from this long-term exposure study will support the expected use of cytisinicline by patients multiple times throughout their journey to nicotine abstinence,” commented Cindy Jacobs, Achieve’s President & Chief Medical Officer. “Additionally, we expect this safety data will be supportive of a future cytisinicline label expansion for vaping cessation.”

Achieve also announced an approximately $124.2 million financing, which includes $60 million upfront from the sale of common stock and up to an additional $64.2 million upon the exercise of milestone-driven warrants. The milestone-driven warrants will expire on the earlier of (i) three and one-half years following the date of issuance and (ii) 30 days following Achieve’s public disclosure of the acceptance of an NDA for cytisinicline by the FDA in a Day 74 Letter or equivalent correspondence. Achieve has also reached non-binding agreement with Silicon Valley Bank on an extension of the maturity date into December 2025 on its outstanding loan.

“We are pleased to now have clarity from the FDA and we are excited about the vote of confidence from leading life science investors who share our enthusiasm for cytisinicline’s potential,” said John Bencich, Achieve’s Chief Executive Officer. “As we continue our discussions with potential commercial partners, we are funded to conduct the ORCA-OL trial and complete the planned NDA submission, bringing us closer to our goal of helping the millions of people who struggle with nicotine dependence.”

Achieve expects that existing cash, cash equivalents and restricted cash, together with the net proceeds from the financing, will provide adequate funding through the anticipated NDA filing in the first half of 2025. If all of the milestone-driven warrants are exercised in full, Achieve expects to have runway into 2026 and through potential FDA approval.

About Achieve and Cytisinicline 
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. There are an estimated 28 million adults in the United States alone who smoke combustible cigarettes.¹ Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.^2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.³