Achieve Life Sciences (ACHV) – Phase 3 Topline results expected 2Q 2023 - smoking cessation and nicotine addiction

Disclaimer (Position): The company and the upcoming catalyst gets a lot of attention, so I am not sure yet how to play it but started a small shares position.

Achieve Life Sciences (ACHV) is a specialty pharmaceutical company committed to addressing the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.


Upcoming Catalyst: Topline results from Cytisinicline (ORCA-3) to treat smoking cessation and nicotine addiction expected in 2Q 2023. This is a binary event as the Phase 3 is seen as registrational trial, so basically it will be the data basis for the submission to the FDA for drug approval.

Previous data shows us the following:

The ORCA-3 trial mirrors the Phase 3 Orca-2, so following design:

  • N=750 (Smokers of ≥10 cigarettes/day and expired air CO > 10 ppm) , 20 sites in the U.S.
  • Completed enrollment in September 2022
  • Evaluate safety and efficacy of 3.0 mg of cytisinicline vs placebo administered 3x daily (TID) for 6 & 12 weeks
  • All subjects received standard behavioral support and were followed out to 24 weeks
  • Multiple Primary Endpoitns: Biochemically verified continuous abstinence during the last 4 weeks of treatment (Arm B: Weeks 3-6; Arm C: Weeks 9-12)
  • Secondary Endpoint: Continuous abstinence from end of treatment through week 24

Market Opportunity and lack of innovative treatment options

  • 1.1b Global Smokers based on a WHO Report on the Global Tobacco Epidemic from 2019
  • ~480K Deaths in the U.S. based on Data from U.S. Department of Health and Human Services from 2022
  • 8 to 11 estimated attempts before quitting successfully.
  • 4 out 5 patients relapse six months post-initiation of treatment with Chantix /Generic version of Chantix (standard of care)
  • No new FDA-approved treatments in the last 15 years
  • Even with a strong trend of global health campaigns and increased awareness the US tobacco Market is still strong and hence the related disease are still a big burden to the healthcare system.

Financials / IP

  • U.S. Patent and Trademark Office (USPTO) issued Patent No. 11,459,328 covering the mesylate salt formulation of cytisinicline and the process for its development.

The recent private placement seems to include warrants as well, ~4.1M units at $4.625/unit, with each unit consisting of two shares and one warrant to buy a share. Therefore, if not already exercised, there is a chance of around 4.1M additional shares (around 20M if fully diluted) that can potentially dilute the current stock price, which is a potential concern down the road.


@Fllwoman and I had a talk on potential revenue and evaluation:

  • Chantix Peak global sales of $1.1B was in 2018, and still $919 million in 2020, withdrawn from market in 2021 due to LOE
  • All FDA-approved products are generic with limited promotion, Generic varenicline expected to reach $300M in US in 2022$
  • I see a potential 250-350m peak sales for cytisiniclinen assuming approval as planned and clear label
  • Analysts provide a PT in the range of $20-25, which we both think its a strong stretch
  • A 8-15$ PT would be more realistic without any further dilution
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  • last subject was dosed in the second Phase 3 ORCA-3 trial in January 2023
  • Topline results are expected in the second quarter of 2023.

No new news, unfortunately i can not access the transcript of the call, so if anyone has access please share the transcript with me.

today announced that the last study follow-up visit for the last subject enrolled in the Phase 3 ORCA-3 trial has occurred

We are pleased to have reached this final milestone in the Phase 3 ORCA-3 trial and continue to expect topline data results from this trial, as well as results from the ORCA-V1 trial of cytisinicline as a treatment for e-cigarette cessation, to be reported in the second quarter of this year

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The run up continues nicely, 13% up today, i am starting to taking profit.

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The primary endpoint for ORCA-V1 was biochemically verified continuous abstinence from nicotine e-cigarette use, measured during the last 4 weeks of treatment. Subjects who received 12 weeks of cytisinicline treatment had 2.6 times higher odds, or likelihood, to have quit vaping during the last 4 weeks of treatment compared to subjects who received placebo (p=0.035). The vaping cessation rate during weeks 9-12 was 31.8% for cytisinicline compared to 15.1% for placebo. A benefit in favor of cytisinicline was consistently observed across the secondary endpoints. Additionally, a cessation benefit was observed for cytisinicline across clinical trial sites and participant demographics such as age, gender, race, or whether they had smoked cigarettes in the past.