SEATTLE, Wash and VANCOUVER, British Columbia, August 6, 2020 — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced second quarter 2020 financial results and provided an update on the cytisinicline clinical development program.

Recent Highlights

  • Announced successful topline results from the investigator initiated RAUORA head-to-head non-inferiority clinical trial comparing cytisinicline and Chantix® (varenicline) as a treatment to quit smoking
  • Closed a Registered Direct Offering for gross proceeds of approximately $6 million, prior to deducting placement agent commissions and estimated offering expenses
  • Entered into an Underwritten Public Offering for estimated gross proceeds of $7.5 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This financing is expected to close on or about August 6, 2020, subject to the satisfaction of customary closing conditions
  • New patent granted in the U.S. for novel analogs of cytisinicline for use in CNS and addiction indications

“It has been a busy and exciting quarter with new evidence further reinforcing our belief that cytisinicline has the potential to provide a more tolerable cessation treatment to millions of smokers who want to quit,” commented Rick Stewart, Chairman and Chief Executive Officer of Achieve. We continue to focus our efforts on initiation of the 750 patient Phase 3 ORCA-2 trial in the second-half of 2020, subject to the ability to conduct the trial safely in light of the COVID-19 pandemic.”

Successful RAUORA Head-to-Head vs Chantix® Study Results  
Achieve announced the successful topline results from the New Zealand RAUORA Phase 3 non-inferiority clinical trial comparing cytisinicline to varenicline (Chantix) in Māori (indigenous New Zealanders) and whānau (family) of Māori. The trial achieved statistical significance in showing that cytisinicline plus behavioral support was at least as effective as varenicline plus behavioral support at six months. In addition, the trial showed that cytisinicline resulted in significantly fewer reported adverse events when compared to varenicline. The study was led by Dr. Natalie Walker, Associate Professor at the University of Auckland, and was funded by the Health Research Council of New Zealand.  The final RAUORA trial results have been submitted for presentation at The Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting in September 2020.

Closed Registered Direct Offering for Gross Proceeds of $6 million
Achieve entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of 731,707 shares of common stock at a price of $8.20 per share in a registered direct offering, resulting in total gross proceeds of approximately $6 million, prior to deducting placement agent fees and estimated offering expenses. The financing was closed in early July 2020.

Entered into an Underwritten Public Offering for Gross Proceeds of $7.5 million
On August 3, 2020, Achieve entered into an Underwritten Public Offering to which it will sell 569,043 shares of common stock, including 92,856 shares subject to the underwriters’ option to purchase additional shares, at a price of $10.50 per share, and 142,857 pre-funded warrants at a price of $10.499 per pre-funded warrant, which represents the per share public offering price for the shares of common stock less $0.001 per shares exercise price for each pre-funded warrant. Total gross proceeds from the offering are expected to be approximately $7.5 million, prior to deducting underwriting discounts and commissions and estimated offering expenses. This financing is expected to close on or about