Achieve Life Sciences (ACHV)

ACHV-Logo

FN Rating

8/10
8/10

FN Summary: Lead asset (cytisinicline) for smoking cessation demonstrated excellent Phase-2b results (~55% better than Chantix™) with superior safety profile. The drug (derived from a plant) has been used for decades in Eastern Europe. Drug is in P3 trial with topline readout due Q1 2022. Might need to raise capital in Q4 2021.

Table of Contents

This company hits most of the right spots!

Experienced Management

High Institutional Ownership

Outstanding Phase 2b Trial

Great Analyst Coverage

Enough cash until next catalyst

Huge Market (Smoking Cessation)

Next Catalyst

Topline readout on ORCA-2 P3 Trial ~ Q1 2022
Countdown Timer 👇
days until Jan 1
P3 readout any day!
Days
Hours
Event Past

Interactive Chart

Cash on Hand

$$$$

29.7M

23M

2.5M

Notes

good cushion...

no warrants!

just an estimate

Est Cash End of May 2021

47M

Should be enough cash until next major catalyst in Q1 2022

Pipeline & Timeline

Products & Sales Potential

Product

Indication

Smoking Cessation

US Market

ROW Market

Achieve LS Market Cap: ~ $66M as of May 3, 2021

Management

Yes, we get it. This is the boring part of the page. But, it is also the most important. Read this: Importance of Management
  • Mr. John Bencich is an experienced financial executive who has spent over 20 years guiding financial strategy in the life sciences and technology industries. Before his appointment to CEO in 2020, Mr. Bencich served as Achieve Life Sciences CFO & COO.
  • Prior to joining Achieve Life Sciences in 2017, John served as CFO of OncoGenex Pharmaceuticals, a publicly traded biotechnology company.
  • Before joining OncoGenex in 2014, John served as CFO of Integrated Diagnostics and Allozyne, both private VC-backed companies. Earlier he served as the CFO and Treasurer of Trubion Pharmaceuticals, a publicly traded biotechnology company where he helped complete the successful sale of the company to Emergent BioSolutions.
  • Prior to his role at Trubion, he led the global financial operations for Onyx Software Corporation, a publicly traded software company through its sale to Battery Ventures.
  • Mr. Stewart has served as Achieve’s Chairman and as a director since Achieve was founded in May 2015. Mr. Stewart is also a founder and a director of Ricanto Limited, a pharmaceutical asset optimization company, since 2009. Mr. Stewart has been Chairman and Chief Executive Officer of Renown Pharma Limited, a central nervous system company focused on Parkinson’s disease, since 2016.
  • Prior to Achieve, Mr. Stewart was Chairman and Chief Executive Officer of Huxley Pharmaceuticals, Inc., a single purpose central nervous system company, during 2009, prior to Huxley Pharmaceuticals, Inc.’s acquisition by BioMarin Pharmaceutical Inc. Mr. Stewart was Chief Executive Officer of Brabant Pharma Limited, a single purpose central nervous system company, from 2013 to 2014 prior to Brabant Pharma’s acquisition by Zogenix Inc.
  • He was a co-founder and Chief Executive Officer of Amarin Corporation plc, a central nervous system company focused on Parkinson’s disease and Huntington’s disease, from 2000 to 2007.
  • Mr. Stewart was a co-founder and Chief Financial Officer, and later Chief Business Officer, of SkyePharma plc, a drug delivery company specializing in controlled release formulations, and held such positions from 1995 to 1998.
  • Dr. Jacobs is an experienced executive in drug development with expertise in several indications and over 30 years’ experience in Biotechnology/Pharmaceutical industry. Dr Jacobs has achieved regulatory success in several product approvals.
  • Prior to joining Achieve Life Sciences in 2017, Dr. Jacobs served as OncoGenex’s Executive Vice President and Chief Medical Officer since August 2008, and had been Executive Vice President and Chief Medical Officer of OncoGenex Technologies Inc. from September 2005 to August 2008.
  • From 1999 to July 2005, Dr. Jacobs served as Chief Medical Officer and Senior Vice President, Clinical Development of Corixa Corporation. Prior to 1999, Dr. Jacobs held Vice President, Clinical Research positions at two other biopharmaceutical companies.  Based on her preclinical work at Immunex Corporation, she is one of 2 inventors on the patent for Enbrel.
  •  
  • Dr. Clarke has served as Achieve’s Chief Scientific Officer and as a member of Achieve’s board of directors since 2015. Dr. Clarke is a founder and director of Ricanto Limited since 2009. From 2016 to the present, Dr. Clarke has been Chief Scientific Officer of Renown Pharma Limited. Dr. Clarke was Chief Scientific Officer of Huxley Pharmaceuticals, Inc. during 2009, prior to Huxley Pharmaceuticals, Inc.’s acquisition by BioMarin Pharmaceutical Inc.
  • Prior to Achieve, Dr. Clarke served as Chief Scientific Officer of Brabant Pharma Limited from 2013 to 2014 prior to Brabant Pharma’s acquisition by Zogenix Inc.
  • Dr. Clarke served as Company Secretary of Alexza UK Ltd. and as Vice President International Development Operations of Alexza Pharmaceuticals Inc., a pharmaceutical development company, holding both positions from 2008 to 2009.
  • Dr. Clarke served as the Vice President, Clinical Research and Regulatory Affairs at Amarin Corporation from 2005 to 2008. In addition, Dr. Clarke was Senior Director, Clinical and Regulatory Affairs, of Cephalon Europe and as Senior Director, Worldwide Pain Management, of Cephalon, Inc. from 2000 to 2004. Dr. Clarke held a number of management roles in other pharmaceutical companies prior to 2000 as well as academic posts and honorary academic posts. He was a Fellow of the Royal Statistical Society (UK) and is a current Fellow of the Royal Society of Medicine (UK).

Clinical Trials

Understanding the Phase 2 trial is crucial to anticipate the success of the current Phase 3 trial.

Here is an overview of the ORCA-1 (Phase 2b) Clinical Trial. The results were outstanding.

The Cytisinicline at 3 mg showed a greater than 200% increase over placebo for continued smoking abstinence. See graph below.

With these results in hand, Achieive LS worked with the FDA to design the Phase 3 trial, which is currently in progress. The trial design is shown below.

Enrollment is expected to be completed mid-2021 with results due Q1 2022.

Company PDFs

(FN posts only the most recent documentation)

Read all of this 👇

Corp Presentation - April 2021

Analyst Price Targets

Zacks $50 price target (not included in TipRanks ranking)

Ownership

Insider Ownership % (not precise)

Insider Transactions

This is a very low amount of insider ownership and buying. This warrants more investigation.

Short Interest

Daily Short Volume Chart

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FAQ

Q. Why does the ticker symbol OGXI occasionally show up when doing DD on ACHV?
A. In Jan of 2017 there was a merger between OncoGenex and Achieve.  There is still some residual of the OGXI ticker symbol.


Q. Has this drug been sold before, and by whom?
A. Yes. It has been sold for decades in Southern/Eastern Europe & Russia by Sopharma. But it is not approved in the US or EU and hence the reason that Achieve LS wants to take it through Phase 3 trials. As the CEO said, “We want to bring the drug out of obscurity, and into the major markets of the world.“.


Q. Is Cytisinicline the same as Cytisine?
A. Yes.


Q. How many Phase 3 trials does the FDA require for this drug?
A. Two.  The ORCA-2 trial is the first of 2 Phase 3 trials required.  See April 27, 2021 SNN video below (17:35 mark).


Q. When will Cytisinicline hit the market?
A. John Vandermosten of Zacks said the following: “ACHV launched the first of its Ph3 trials in 3Q:20 and will began enrolling
in earnest in early 2021. We anticipate a 2024 commercialization of cytisinicline.”

Risks

Phase 3 was put on a complete pause as hospitals focused exclusively on Covid patients. It is possible that a data variation was created which will adversely affect the results.

Phase 3 pulls in a much larger group of patients. Anytime this occurs, new variables can be introduced that Phase 2 did not uncover. These variables can cause adverse results resulting in the company not hitting their endpoints.

FN Nugget: Due to the black box warning the FDA put on Chantix, the FDA is heavily scrutinizing smoking cessation drugs. This is also the reason they are requiring 2 Phase 3 trials for cytisinicline. The current ORCA-2 Phase 3 trial is the first. Another one will occur later as per the SNN video above (17:35 mark). This is another hurdle the drug must overcome to be approved. The date for the 2nd trial has not been set.

Email us at info@frugalnorwegian.com if you have more.  We want to list all risk factors for the drug & trial.

Have questions about this info? Did we miss a fact? We want to hear from you.

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