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ACHV: ORCA-2 Enrollment On Track

·9 min read

By John Vandermosten, CFA

NASDAQ:ACHV

READ THE FULL ACHV RESEARCH REPORT

First Quarter 2021 Results

Achieve Life Sciences, Inc. (NASDAQ:ACHV) reported first quarter results in a press release and held a conference call after market close to discuss details therein on May 13, 2021. The company concurrently filed its Form 10-Q with the SEC.

Highlights for the first quarter, and to-date include:

➢ Presentation of Smoker and E-Cigarette Quitting Survey at SRNT - February 2021

➢ Appointment of Dr. Bridget Martell and Dr. Cindy Jacobs to Board - March 2021

➢ Publication of RAUORA Trial in Addiction - March 2021

➢ Publication of ORCA-1 Phase IIb Trial in Nicotine and Tobacco Research - April 2021

Achieve produced no revenues in 1Q:21 and incurred operating expense of ($7.98) million yielding net loss of ($8.00) million or ($1.30) per share.

For the quarter ending March 31, 2021 and versus the year-ago quarter ending March 31, 2020:

➢ Research & development expense rose 273% to $5.64 million from $1.54 million attributable to the launch and ongoing enrollment for the Phase III ORCA-2 trial;

➢ General & administrative expense rose 28.6% to 2.34 million from $1.82 million due to higher stock-based compensation and clinical trial media and awareness expenses;

➢ Net loss was ($8.00) million vs. ($3.32) million or on a per share basis ($1.30) and ($2.15) with the seeming disconnect between net loss and per share values attributable to an increase in shares outstanding.

As of March 31, 2021, cash and equivalents totaled $29.6 million. This amount compares to a $35.9 million balance in cash and equivalents held at the end of 2020. Achieve carries no debt on its balance sheet. Cash used in operations was $6.45 million, up 45% from the $4.46 million consumed in 1Q:20. After a slow start in 2021, Achieve’s Phase III ORCA-2 trial is now on track to be fully enrolled, as scheduled, in mid-2021.

Interview with CEO John Bencich

In April, we held a question and answer session with CEO John Bencich where we reviewed the background on cytisinicline, recent study results and what lies ahead for the company. Follow link here to view.

ORCA-2 Phase III Trial

Achieve announced the start of its Phase III ORCA-2 trial on October 7th 2020, targeting enrollment of 750 smokers at 15 clinical sites throughout the United States. The trial is a multi-center, double-blind, randomized, placebo-controlled Phase III study that will enroll adult cigarette smokers who intend to quit smoking. Subjects will be randomized into one of three arms which include 12 weeks of placebo, six weeks of cytisinicline then six weeks of placebo or 12 weeks of cytisinicline. Dosing will be 3.0 mg, three times daily in each of the treatment cohorts. This dosing regimen is expected to be effective against even high nicotine use prior to cessation as cytisinicline efficiently binds nicotinic acetylcholine receptors.

The trial began with a slower than expected enrollment rate due to impacts related to the coronavirus and severe winter weather in the South; however, the rate accelerated at the end of the first quarter and ORCA-2 should enroll the targeted 750 subjects by mid-year. Two new sites were added in Atlanta, Georgia and Evansville, Indiana since our last update, bringing the total to 17. There will be a six-month follow up period after the measurement at week 12 measurement which should be complete by the end of the year. Then the data analysis portion will begin and topline results are anticipated to be available by spring 2022.

Appointment of Drs. Bridget Martell and Cindy Jacob to the Board

Achieve announced on March 15, 2021 that Drs. Bridget Martell and Cindy Jacobs were appointed to Achieve’s Board of Directors. Dr. Cindy Jacobs has served as Achieve’s Chief Medical Officer and President before taking on the additional role as Director. She will continue leading the regulatory and clinical development for cytisinicline, leveraging her 30 years of experience in industry.

Dr. Martell brings a background with scientific, clinical and leadership experience. Martell is board certified in both Internal and Addiction Medicine, practicing over 20 years as a physician at Yale. She continues to serve at Yale as an Entrepreneur in Residence at the Office of Cooperative Research and has held leadership positions and executive roles at Pfizer, Kura Oncology and Juniper Pharmaceuticals. Dr. Martell holds a B.Sc. in Microbiology from Cornell University, an M.A. in Molecular Immunology from Boston University, and an M.D. from The Chicago Medical School.

RAUORA Publication

Following the completion of the RAOURA trial in early 2020, topline results were provided in the summer of that year. Further data analysis was conducted from the RAOURA study and a paper was written which was published in the scientific journal Addiction. The piece, entitled Cytisine versus varenicline for smoking cessation in New Zealand indigenous Māori: a randomized controlled trial provided additional detail regarding the statistical methods and trial design used and subgroup analysis.

The first subject was enrolled in September 2017 and the last follow up occurred in October 2019 for this New Zealand-based smoking cessation project comparing cytisinicline with varenicline. Sample size was lower than the initially anticipated 2,140 subjects due to delays related to ethics and regulatory approvals and slower than anticipated recruitment. Ultimately, 679 subjects were randomized, 337 in the cytisinicline group and 342 in the varenicline group. Continuous abstinence at six months post-quit date were 12.1% for cytisinicline vs. 7.9% for varenicline. However, zero remained within the 95% confidence interval and cytisinicline was not considered superior despite a mean that was better than varenicline.

ORCA-1 Publication

On April 14, 2021, Achieve announced that details for the Phase IIb ORCA-1 trial had been published in the journal Nicotine and Tobacco Research. The publication was entitled “A Multicenter, Double-blind, Randomized, Placebo-controlled Phase 2b Trial of Cytisinicline in Adult Smokers (The ORCA-1 Trial).” ORCA-1 evaluated safety and efficacy of cytisinicline in various dosing and administration schedules and enrolled 254 smokers in the US. All subjects treated with cytisinicline in the trial had statistically significant (p<0.001) end of treatment abstinence rates compared to placebo. The 3 mg cytisinicline TID arm had a five-fold higher likelihood of quitting (p<0.001). No serious or severe adverse events were reported. Adverse events were below 10% in the 3 mg TID arm versus placebo. Most common adverse events were abnormal dreams, insomnia and constipation, at 6% vs 2% in placebo, upper respiratory tract infection, at 6% vs 14% in placebo, and nausea at 6% vs 10% in placebo. Treatment adherence was greater than 94% in all treated arms, and 98% in the 3 mg TID arm.

Presentation of Data on Smoker and E-Cigarette User Attitudes and Perceptions Toward Quitting

Achieve presented three posters on February 25, 2021 at the Society for Research on Nicotine & Tobacco (SRNT) Annual Meeting, held virtually this year. The posters featured survey data on smoker and e-cigarette user behavior. A recap of the survey results are discussed in our recent article.

The posters were titled:

➢ “A Survey in the United States of Attitudes to Nicotine Cessation in Smokers: Smokers’ Satisfaction with Available Treatments” (PH-293)

➢ “A Survey in the United States of Attitudes to Nicotine Cessation in Vapers: Reasons for Choosing to Vape” (PH-294)

➢ “A Survey in the United States of Attitudes to Nicotine Cessation in Vapers: Their Plans to Quit Vaping” (PH-295)

ORCA Vaping Trial

While smoking has shown declines in prevalence in the last decades, it has been replaced by another popular form of nicotine consumption: vaping. Last year, Achieve announced a collaboration with the FreeMind Group to identify non-dilutive funding to support the launch of a clinical trial that will evaluate the effectiveness of cytisinicline in subjects that are vaping and using e-cigarettes. The study will likely include 150 subjects that are vaping, but not smoking. Randomization will be divided into a 2:1 split with 100 receiving twelve weeks of cytisinicline and 50 on placebo. Dosing is expected to follow the regimen evaluated in ORCA-2: 3 mg three times daily. The Phase II study will examine vaping cessation as the endpoint at the six week and twelve week point by measuring cotinine levels.3 If the trial is successful and generates statistically significant results, it could provide support, along with a successful ORCA-2, to require only one Phase III to obtain approval. Achieve continues to explore funding opportunities for Phase II ORCA-V1, and expects to share additional details on its application status later this year.

Key Events

➢ SRNT poster presentations - February 2021

➢ Completion of enrollment in ORCA-2 – mid-year 2021

➢ Additional detail on funding application status for vaping trial – 2021

➢ Possible vaping trial ORCA-VI – 2021/2022

➢ Topline readout of ORCA-2 – 1H:22

➢ Initiation of ORCA-3 - 2022

Summary

Highlights from Achieve’s first quarter 2021 included the presentation of survey data for attitudes and perceptions towards quitting at the SRNT, appointment of Drs. Bridget Martell and Cindy Jacobs to the Board and publications of the RAUORA and ORCA-1 studies in Addiction and Nicotine and Tobacco Research.

After the turn of the year, enrollment for ORCA-2 advanced at a slower pace than anticipated due to the pandemic and winter weather. Management has taken steps to drive enrollment to the study including adding extra sites and anticipates full enrollment by mid-2021. Following completion of ORCA-2, Management expects ORCA-3 to initiate sometime in 2022. Vaping presents yet another opportunity for cytisinicline, and non-dilutive funding opportunities are currently being explored, with an update expected later this year.

Cytisinicline, with its established use in Central and Eastern Europe and potentially superior data in pivotal trials, has a material opportunity to provide for an unmet need in smokers who wish to quit, but are wary of side effects and lack of efficacy in existing alternatives. US patents for Pfizer’s Chantix, which represents standard of care in smoking cessation, expired in November 2020,5 and generic competition is expected to mount within a year or two. This gives an opportunity for cytisinicline to come to market, offering both a low-side effect alternative to Chantix and several years of intellectual property protection.

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1. Source: SNN hosted interview with Zacks SCR biotech analyst John Vandermosten and Achieve Life Sciences CEO John Bencich. Achieve Life Sciences Inc. (NASDAQ: ACHV) - Virtual NDR on April 27, 2021 | SNN Network

2. Source: Achieve Life Sciences S-1 Filed November 6, 2019.

3. Cotinine is a metabolite of nicotine, and cotinine urine or blood testing is considered highly accurate for assessing nicotine use, including vaping.

4. Source: Achieve Life Sciences October 2020 Corporate Presentation

5. Pfizer FY:20 10-K