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Achieve Life Sciences (ACHV)

Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide. and nearly half a million deaths in the U.S. annually.12 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke. Achieve's focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

Company profile

Ticker
ACHV
Exchange
CEO
Richard Stewart
Employees
Incorporated
Location
Fiscal year end
Former names
ONCOGENEX PHARMACEUTICALS, INC., SONUS PHARMACEUTICALS INC
SEC CIK
Subsidiaries
Achieve Life Sciences Technologies Inc., incorporated • Achieve Life Science Inc. • Extab Corporation • Achieve Pharma UK Limited, a Limited Company ...
IRS number
954343413

ACHV stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

10 Aug 22
12 Aug 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 29.43M 29.43M 29.43M 29.43M 29.43M 29.43M
Cash burn (monthly) 2.32M 1.05M 6.75M 5.21M 2.77M 2.42M
Cash used (since last report) 3.32M 1.51M 9.67M 7.47M 3.97M 3.46M
Cash remaining 26.11M 27.92M 19.76M 21.96M 25.46M 25.97M
Runway (months of cash) 11.3 26.5 2.9 4.2 9.2 10.7

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
1 Aug 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 - 23.46K -
1 Aug 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 - 23.46K -
1 Aug 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 - 46.91K -
1 Jul 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 22,568.69 210.79K 3,891,486.89
1 Jul 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 22,568.69 210.79K 3,891,486.89
1 Jul 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 45,137.38 421.58K 7,782,973.79
1 Jun 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 22,437.8 209.57K 3,868,918.2
1 Jun 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 22,437.8 209.57K 3,868,918.2
1 Jun 22 SVB Financial Common Stock Other Acquire J Yes No 9.34 44,875.6 419.14K 7,737,836.41
31 May 22 Moyes Jay M Stock Option Common Stock Grant Acquire A No No 6.9 4,400 30.36K 4,400
13F holders Current Prev Q Change
Total holders 0 0
Opened positions 0 0
Closed positions 0 0
Increased positions 0 0
Reduced positions 0 0
13F shares Current Prev Q Change
Total value 0 0
Total shares 0 0
Total puts 0 0
Total calls 0 0
Total put/call ratio
Largest owners Shares Value Change
Largest transactions Shares Bought/sold Change

Financial report summary

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Risks
  • Risks Related to Our Financial Condition and Capital Requirements
  • We have never generated any revenue from product sales and may never be profitable.
  • We are dependent upon a single company for the manufacture and supply of cytisinicline.
  • Cytisinicline is currently our sole product candidate and there is no guarantee that we will be able to successfully develop and commercialize cytisinicline.
  • Results of earlier clinical trials of cytisinicline are not necessarily predictive of future results, and any advances of cytisinicline into clinical trials may not have favorable results or receive regulatory approval.
  • Cytisinicline may cause undesirable side effects or have other properties that could delay or prevent regulatory approval, limit the commercial viability of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Our business may be negatively affected by weather conditions, natural disasters, and the availability of natural resources, as well as by climate change.
  • We may conduct clinical trials internationally, which may trigger additional risks.
  • If we do not obtain the necessary regulatory approvals in the United States and/or other countries, we will not be able to sell cytisinicline.
  • Ongoing post-approval monitoring and clinical trial obligations may be costly to us and the failure to meet such obligations may result in the withdrawal of such approvals.
  • Our ability to obtain services, reimbursement or funding may be impacted by possible reductions in federal spending in the United States as well as globally.
  • Our employees, independent contractors, consultants, commercial partners, principal investigators, or CROs may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.
  • It is difficult to evaluate our current business, predict our future prospects and forecast our financial performance and growth.
  • Our future success depends in part on our ability to attract, retain, and motivate other qualified personnel.
  • We will need to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations.
  • Our internal computer systems, or those of our third-party collaborators or other service providers, may fail or suffer security breaches and cyber attacks, which could result in a material disruption of our development programs.
  • We may not be able to establish or maintain the third-party relationships that are necessary to develop or potentially commercialize cytisinicline.
  • We may be unable to realize the potential benefits of any collaborations which we may enter into with other companies for the development and commercialization of cytisinicline.
  • We enter into various contracts in the normal course of our business in which we indemnify the other party to the contract. In the event we have to perform under these indemnification provisions, it could have a material adverse effect on our business, financial condition and results of operations.
  • We may rely on third parties to perform many essential services for any of our current or future product candidates that we commercialize, including services related to warehousing and inventory control, distribution, government price reporting, customer service, accounts receivable management, cash collection, and adverse event reporting. If these third parties fail to perform as expected or to comply with legal and regulatory requirements, our ability to commercialize any of our current or future product candidates will be significantly impacted and we may be subject to regulatory sanctions.
  • We face substantial competition and our competitors may discover, develop or commercialize products faster or more successfully than us.
  • The commercial success of cytisinicline will depend upon the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community. Failure to obtain or maintain adequate reimbursement or insurance coverage for products, if any, could limit our ability to market cytisinicline and decrease our ability to generate revenue.
  • Sopharma may breach its supply agreement with us and sell cytisinicline into our territories or permit third parties to export cytisinicline into our territories and negatively affect our commercialization efforts of our products in our territories.
  • The illegal distribution and sale by third parties of counterfeit versions of cytisinicline, stolen products, or alternative third-party distribution and sale of cytisinicline could have a negative impact on our financial performance or reputation.
  • We may attempt to form collaborations in the future with respect to cytisinicline, but we may not be able to do so, which may cause us to alter our development and commercialization plans.
  • We may not be successful in any efforts to identify, license, discover, develop, or commercialize additional product candidates.
  • We may not be successful in obtaining or maintaining necessary rights to cytisinicline, product compounds and processes for our development pipeline through acquisitions and in-licenses.
  • If we are unable to maintain effective proprietary rights for our product candidate or any future product candidates, we may not be able to compete effectively in our proposed markets.
  • Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.
  • We intend to rely on patent rights for certain aspects of our product candidates and certain future product candidates. If we are unable to obtain or maintain an adequate proprietary position from this approach, we may not be able to compete effectively in our markets.
  • Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
  • It is difficult and costly to protect our proprietary rights and as a result we may not be able to ensure their protection. In addition, patents have a limited lifespan and will eventually expire.
  • Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.
  • We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful.
  • We or our licensors may not be able to protect our intellectual property rights throughout the world.
  • Because our merger resulted in an ownership change under Section 382 of the U.S. Internal Revenue Code for OncoGenex, pre-merger net operating loss carryforwards and certain other tax attributes are now subject to limitations.
  • If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about us, our business, or our market, our stock price and trading volume could decline.
  • We incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies.
  • If we raise additional capital, the terms of the financing transactions may cause dilution to existing stockholders or contain terms that are not favorable to us.
  • Anti-takeover provisions under Delaware law could make an acquisition of us more difficult and may prevent attempts by our stockholders to replace or remove our management.
  • Our bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.
Management Discussion
  • R&D expenses for the three and six months ended June 30, 2022 decreased to $7.2 million and $11.6 million, respectively, from $9.2 million and $14.9 million for the three and six months ended June 30, 2021, respectively. The decrease in the three and six months ended June 30, 2022 as compared to the same periods in 2021 was primarily due to timing of the initiation of our Phase 3 ORCA-3 trial, which initiated in January 2022, and our Phase 3 ORCA-2 trial, which initiated in October 2020 and ramped up through the first half of 2021. We anticipate R&D expenses to increase in the second half of 2022 with the initiation of the ORCA-V1 trial.
  • General and administrative expenses for the three and six months ended June 30, 2022 increased to $2.9 million and $5.7 million, respectively, from $2.1 million and $4.4 million for the three and six months ended June 30, 2021, respectively. The increase was primarily due to higher clinical trial media and awareness expenses, employee expenses associated with stock-based compensation, higher legal expenses as a result of increased patent application activities and increase in insurance premiums.

Content analysis

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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. junior Avg
New words: assuming, classification, composition, doubt, Haleon, inflation, pace, twelve
Removed: advancement, assessed, cytisincline, fall, settle

Patents

Utility
Compositions Comprising Cytisine In the Treatment And/or Prevention of Addiction In Subjects In Need Thereof
28 Oct 21
Methods of treatment of addiction and/or dependence, methods of promoting cessation of various addictions, such as smoking and/or vaping, and methods of promoting a reduction in various addictions, such as smoking and/or vaping, uses of cytisine as an addiction cessation treatment, and dosage regimens for the foregoing are provided.
Utility
Compositions comprising cytisine in the treatment and/or prevention of addiction in subjects in need thereof
10 Aug 21
Methods of treatment of addiction and/or dependence, methods of promoting cessation of various addictions, such as smoking and/or vaping, and methods of promoting a reduction in various addictions, such as smoking and/or vaping, uses of cytisine as an addiction cessation treatment, and dosage regimens for the foregoing are provided.
Utility
Compositions comprising cytisine in the treatment and/or prevention of addiction in subjects in need thereof
10 Aug 21
Methods of treatment of addiction and/or dependence, methods of promoting cessation of various addictions, such as smoking and/or vaping, and methods of promoting a reduction in various addictions, such as smoking and/or vaping, uses of cytisine as an addiction cessation treatment, and dosage regimens for the foregoing are provided.
Utility
Compositions Comprising Cytisine In the Treatment And/or Prevention of Addiction In Subjects In Need Thereof
18 Mar 21
Methods of treatment of addiction and/or dependence, methods of promoting cessation of various addictions, such as smoking and/or vaping, and methods of promoting a reduction in various addictions, such as smoking and/or vaping, uses of cytisine as an addiction cessation treatment, and dosage regimens for the foregoing are provided.
Utility
Compositions Comprising Cytisine In the Treatment And/or Prevention of Addiction In Subjects In Need Thereof
18 Mar 21
Methods of treatment of addiction and/or dependence, methods of promoting cessation of various addictions, such as smoking and/or vaping, and methods of promoting a reduction in various addictions, such as smoking and/or vaping, uses of cytisine as an addiction cessation treatment, and dosage regimens for the foregoing are provided.