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ACHV Achieve Life Sciences

Achieve Life Sciences, Inc. is a clinical-stage pharmaceutical company, which engages in the development and commercialization of cytisinicline for smoking cessation. Its products includes cytisine, a plant-based alkaloid with a binding affinity to the nicotinic acetylcholine receptor. The company was founded in October 1991 and is headquartered in Vancouver, Canada.

Company profile

Ticker
ACHV
Exchange
CEO
Richard Stewart
Employees
Incorporated
Location
Fiscal year end
Former names
ONCOGENEX PHARMACEUTICALS, INC., SONUS PHARMACEUTICALS INC
SEC CIK
IRS number
954343413

ACHV stock data

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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

13 May 21
2 Aug 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
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Cost of revenue
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Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
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Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 29.69M 29.69M 29.69M 29.69M 29.69M 29.69M
Cash burn (monthly) 2.07M (positive/no burn) 5.37M 3.26M 2.15M 1.29M
Cash used (since last report) 8.47M n/a 21.92M 13.33M 8.79M 5.27M
Cash remaining 21.22M n/a 7.76M 16.36M 20.9M 24.42M
Runway (months of cash) 10.2 n/a 1.4 5.0 9.7 18.9

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
27 May 21 John Bencich Common Stock Buy Aquire P No No 7 6,000 42K 6,141
11 May 21 Joseph Donald Stock Option Common Stock Grant Aquire A No No 9.9 3,750 37.13K 3,750
11 May 21 Mattingly Martin A Stock Option Common Stock Grant Aquire A No No 9.9 3,750 37.13K 3,750
11 May 21 Moyes Jay M Stock Option Common Stock Grant Aquire A No No 9.9 3,750 37.13K 3,750

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

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
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Total value 0 0
Total shares 0 0
Total puts 0 0
Total calls 0 0
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Financial report summary

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Risks
  • We have incurred losses since inception, have a limited operating history on which to assess our business and anticipate that we will continue to incur losses for the foreseeable future.
  • 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.
  • Clinical trials are costly, time consuming and inherently risky, and we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
  • Cytisinicline may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial viability of an approved label, or result in significant negative consequences following marketing approval, if any.
  • Our product development program may not uncover all possible adverse events that patients who take cytisinicline or our other product candidates may experience. The number of subjects exposed to cytisinicline or our other product candidates and the average exposure time in the clinical development program may be inadequate to detect rare adverse events, or chance findings, that may only be detected once the product is administered to more patients and for greater periods of time.
  • If the use or misuse of cytisinicline harms patients, or is perceived to harm patients even when such harm is unrelated to cytisinicline, our regulatory approvals, if any, could be revoked or otherwise negatively impacted and we could be subject to costly and damaging product liability claims. If we are unable to obtain adequate insurance or are required to pay for liabilities resulting from a claim excluded from, or beyond the limits of, our insurance coverage, a material liability claim could adversely affect our financial condition.
  • The development of our product candidate is dependent upon securing sufficient quantities of cytisinicline from the Laburnum anagyroides plant, which grows outside of the United States in a limited number of locations.
  • Our business may be negatively affected by weather conditions and the availability of natural resources, as well as by climate change.
  • We may conduct clinical trials internationally, which may trigger additional risks.
  • We may use our financial and human resources to pursue a particular research program or product candidate and fail to capitalize on programs or product candidates that may be more profitable or for which there is a greater likelihood of success.
  • 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.
  • Even if we obtain regulatory approval for cytisinicline, we will remain subject to ongoing regulatory requirements in connection with the sale and distribution of 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.
  • We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.
  • Healthcare legislative and executive reform measures may have a material adverse effect on our business, financial condition or results of operations.
  • 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.
  • 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.
  • We expect to continue to rely on third parties to manufacture cytisinicline for use in clinical trials, and we intend to exclusively rely on Sopharma to produce and process cytisinicline, if approved. Our commercialization of cytisinicline could be stopped, delayed or made less profitable if Sopharma fails to obtain approval of government regulators, fails to provide us with sufficient quantities of product, or fails to do so at acceptable quality levels or prices.
  • We rely on third parties to conduct our clinical trials and perform other services. If these third parties do not successfully perform and comply with regulatory requirements, we may not be able to successfully complete clinical development, obtain regulatory approval or commercialize cytisinicline and our business could be substantially harmed.
  • 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 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.
  • 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.
  • We are at risk of securities class action litigation.
  • 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.
  • U.S. federal tax reform and changes in other tax laws could increase our tax burden and adversely affect our business and financial condition.
Management Discussion
  • R&D expenses for the three months ended March 31, 2021 increased to $5.6 million from $1.5 million for the three months ended March 31, 2020. The increase in R&D expenses for the three months ended March 31, 2021 as compared to the same period in 2020 was due to costs incurred as a result of enrollment activity in our Phase 3 ORCA-2 trial that was initiated in the fourth quarter of 2020.
  • General and administrative expenses for the three months ended March 31, 2021 increased to $2.3 million from $1.8 million for the three months ended March 31, 2020. The increase was due to higher employee expenses associated with stock-based compensation and clinical trial media and awareness expenses.
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