ACHV: RAUORA: Cytisinicline's Superior Side Effect Profile

By John Vandermosten, CFA

NASDAQ:ACHV

On Monday, Achieve Life Sciences, Inc. ACHV updated the investment community on the status of New Zealand's RAUORA¹ study, which was expected to announce completion in the months leading up to the September SRNT conference. While full results were not provided, the study's principal investigator did announce that cytisinicline was as good as Chantix at helping smokers quit and that the cytisinicline group experienced fewer side effects than the Chantix group.

The study's principal investigator, Dr. Natalie Walker of the University of Auckland, determined that the cytisinicline arm was just as good as the Chantix arm at six months in helping smokers to quit, with fewer reported adverse events. Final results of the trial, which will include quit rates and their statistical significance, will be provided at the Society for Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting in September 2020 which will be held virtually. We believe that, even if cytisinicline is only as effective as Chantix for patients that undergo the full course of therapy, outcomes will be better for cytisinicline as more patients will complete the treatment due to fewer side effects.

Achieve has also optimized the dosing regimen in the upcoming Phase III trial to improve efficacy and to match the 12-week course of therapy used by Chantix. Extensive dose ranging and dose limiting studies were conducted and the product was found to be safe at much higher doses than what has been used in Europe. The Phase III trial will increase the dose to 3.0 mg, three times daily, compared to the prior increasing titration schedule that was at lower strengths. The protocol will also employ a 12-week regimen of cytisinicline to allow the primary endpoint to be measured while the patients are on therapy, which we expect will improve quit rates over the 25-day regimen that has been historically used.

RAUORA New Zealand Study

The Cytisine vs. Varenicline for Smoking Cessation (RAUORA) Phase III trial began in 2017 and was conducted in New Zealand. It was a head to head comparison of cytisinicline and varenicline to evaluate the safety, efficacy, and cost of cytisinicline compared to varenicline. Both groups were provided behavioral support for smoking cessation and the trial was conducted in the native Māori population.

The study initially sought enrollment of 2,140 Māori or family of Māori; however, it ultimately enrolled 679 subjects due to funding limitations. It consisted of 12 weeks of treatment and subsequent monitoring for up to a year where participants were randomized 1:1 between cytisinicline and varenicline. It was designed as an open-label, randomized, non-inferiority trial. While not yet reported, the primary endpoint will be smoking cessation six months after the quit date as measured by carbon monoxide expired breath meter. Secondary endpoints look at absence of smoking at other intervals and time to relapse, if it occurs. This will be the first head to head trial to report a comparison of cytisinicline and varenicline and is expected to provide indications of these two smoking cessation therapies.

Capital Raise

In conjunction with the RAUORA announcement Achieve priced $6 million of capital in a registered direct offering. The company entered into a securities purchase agreement with institutional investors to sell 14.6 million shares of common stock at $0.41 per share. The financing is expected to close tomorrow and was executed at Friday's closing price. No warrants were issued in conjunction with the raise and it was completed at Friday, June 26th closing value. We estimate that, including this capital, Achieve should hold approximately $13 million in cash on the balance sheet as 2Q:20 quarter end.

Summary

We had been anticipating the results of RAUORA for some time and are pleased to see the improved side effect profile confirmed in a head to head trial against Chantix. We believe that cytisinicline will be a strong candidate for smoking cessation if it is able to maintain or improve the success it has seen in studies conducted to date. With favorable data, Achieve becomes a desirable asset for big pharma that already hold a presence in the smoking cessation market. We continue to anticipate a start to the Phase III trial before year end and also expect to see the announcement of funding related to the vaping trial, which will keep eyes on the effectiveness of cytisinicline as it pursues approval to address nicotine addiction.

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1. Rauora is the Māori word for rescue