Achieve Life Sciences, Inc. (ACHV) Bundle
An Overview of Achieve Life Sciences, Inc. (ACHV)
General Overview of Achieve Life Sciences, Inc. (ACHV)
Achieve Life Sciences, Inc. (ACHV) is a late-stage pharmaceutical company focused on developing cytisinicline, a treatment for nicotine dependence. The company was incorporated in Delaware and operates from Seattle, Washington, and Vancouver, British Columbia. Since its inception, Achieve has aimed to address the global nicotine addiction epidemic associated with combustible cigarettes and e-cigarettes. Cytisinicline is a plant-based alkaloid that binds to nicotinic acetylcholine receptors in the brain, which is believed to aid in reducing withdrawal symptoms and cravings associated with nicotine cessation.
As of 2024, Achieve Life Sciences has no products approved for commercial sale and has not generated any revenue from product sales to date. The company has incurred significant losses, with an accumulated deficit of $193.2 million through September 30, 2024. The cash, cash equivalents, and short-term investments balance stands at $42.9 million, alongside a positive working capital of $38.8 million.
Company's Financial Performance in Latest Financial Reports
For the nine months ended September 30, 2024, Achieve Life Sciences reported a net loss of $27.5 million, compared to a net loss of $24.3 million for the same period in 2023. The total operating expenses for the nine months were $26.9 million, up from $22.9 million in the previous year. Research and development expenses increased to $15.5 million from $13.7 million, primarily due to the initiation and ramp-up of the ORCA-OL open-label safety trial.
The company's general and administrative expenses were $11.4 million for the nine months ended September 30, 2024, compared to $9.2 million in the same period of 2023. The increase was attributed to higher employee expenses, including severance costs, consulting costs, and legal fees. Interest income for the nine months was $1.9 million, while interest expenses totaled $2.0 million.
The following table summarizes the financial performance for Achieve Life Sciences as of September 30, 2024:
| Financial Metric | 2024 (9 Months) | 2023 (9 Months) |
|---|---|---|
| Net Loss | $27.5 million | $24.3 million |
| Total Operating Expenses | $26.9 million | $22.9 million |
| Research and Development Expenses | $15.5 million | $13.7 million |
| General and Administrative Expenses | $11.4 million | $9.2 million |
| Interest Income | $1.9 million | $0.6 million |
| Interest Expense | $2.0 million | $2.1 million |
Introduction to Achieve Life Sciences as an Industry Leader
Achieve Life Sciences is recognized as a leader in the field of nicotine addiction treatment, particularly with its investigational product candidate, cytisinicline. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for cytisinicline for nicotine e-cigarette cessation, underscoring its potential impact on public health. This designation facilitates expedited development and review processes, reflecting the drug's promise in addressing significant unmet medical needs.
Despite not having any products on the market yet, Achieve's commitment to advancing cytisinicline through clinical trials positions it as a key player in the pharmaceutical industry dedicated to tackling nicotine dependence. The ongoing development and expected regulatory submissions are crucial for its future success.
Mission Statement of Achieve Life Sciences, Inc. (ACHV)
Company's Mission Statement
Achieve Life Sciences, Inc. (ACHV) is dedicated to addressing the global nicotine addiction epidemic through the development and commercialization of cytisinicline, a novel treatment aimed at aiding individuals in overcoming nicotine dependence. The mission statement emphasizes the company’s commitment to improving public health by providing effective solutions for smoking cessation and nicotine addiction.
Core Component 1: Commitment to Innovation
Achieve Life Sciences prioritizes innovation in its approach to developing cytisinicline. The company aims to create a unique treatment option that stands apart from existing therapies. Cytisinicline is a plant-based alkaloid that interacts with nicotinic receptors in the brain, potentially reducing withdrawal symptoms and cravings. The FDA granted Breakthrough Therapy designation for cytisinicline, indicating its potential to substantially improve treatment options for nicotine dependence.
According to the latest data, tobacco use leads to over 8 million deaths annually worldwide, with nicotine e-cigarettes affecting approximately 11 million adults in the U.S. alone. Achieve Life Sciences is positioned to make a significant impact in this space by advancing cytisinicline through clinical trials, including the ORCA-OL safety trial initiated in May 2024.
Core Component 2: Focus on Patient Outcomes
Patient outcomes are central to Achieve Life Sciences' mission statement. The company’s goal is to provide effective treatments that improve the quality of life for individuals struggling with nicotine addiction. Cytisinicline, if approved, could be one of the first new prescription medications in nearly two decades aimed at assisting individuals in quitting smoking.
Research indicates that more than 87% of lung cancer deaths are attributable to smoking, highlighting the urgent need for effective cessation therapies. Achieve Life Sciences is committed to conducting rigorous clinical trials to ensure that cytisinicline is safe and effective for patients, thereby enhancing public health outcomes.
Core Component 3: Commitment to Quality and Compliance
Achieve Life Sciences emphasizes the importance of quality and compliance in its operations. The company adheres to stringent regulatory guidelines to ensure that its products meet the highest standards of safety and efficacy. The ongoing clinical trials for cytisinicline are designed to comply with FDA requirements, reflecting the company’s dedication to responsible development practices.
As of September 30, 2024, Achieve Life Sciences reported an accumulated deficit of $193.2 million and net losses of $27.5 million for the nine months ended. Despite these challenges, the company maintains a positive working capital balance of $38.8 million, underscoring its ability to fund ongoing research and development activities while ensuring compliance with regulatory standards.
| Financial Indicator | Amount (in millions) |
|---|---|
| Accumulated Deficit | $193.2 |
| Net Loss (9 months ended September 30, 2024) | $27.5 |
| Cash, Cash Equivalents & Short-term Investments | $42.9 |
| Positive Working Capital | $38.8 |
| R&D Expenses (9 months ended September 30, 2024) | $15.5 |
Vision Statement of Achieve Life Sciences, Inc. (ACHV)
Vision Statement Overview
Achieve Life Sciences, Inc. (ACHV) aims to address the global nicotine addiction epidemic through the development and commercialization of cytisinicline, a plant-based alkaloid proposed for smoking cessation therapy. The company envisions a future where effective treatment options for nicotine dependence are accessible, thereby improving public health outcomes.
Commitment to Innovation
Achieve Life Sciences focuses on innovative solutions in nicotine addiction treatment. The company has invested significantly in research and development, with $15.5 million allocated for R&D expenses in the nine months ending September 30, 2024. This commitment reflects their vision of pioneering advancements in pharmaceutical development aimed at reducing nicotine dependence.
Global Health Impact
Achieve's vision emphasizes the importance of impacting global health by addressing nicotine addiction. With approximately 29 million adults in the U.S. smoking combustible cigarettes and 11 million using e-cigarettes, the potential market for cytisinicline is substantial. The company aims to become a leading player in the smoking cessation market, which has seen minimal new entrants in nearly two decades.
Clinical Development Goals
The company is currently advancing the clinical development of cytisinicline, with plans to submit a New Drug Application (NDA) to the FDA. The ongoing ORCA-OL trial aims to further validate the efficacy of cytisinicline. Achieve's vision encompasses not only gaining regulatory approval but also achieving a position where they can effectively commercialize cytisinicline to meet the needs of millions struggling with nicotine addiction.
Financial Health and Future Growth
As of September 30, 2024, Achieve reported cash and cash equivalents of $9.5 million and short-term investments of $33.4 million. The company has incurred an accumulated deficit of $193.2 million. Achieve Life Sciences aims to secure additional funding through equity offerings and partnerships to support its growth objectives and clinical trials.
| Financial Metric | Q3 2024 Amount | Q3 2023 Amount |
|---|---|---|
| Net Loss | $27.5 million | $24.3 million |
| Cash and Cash Equivalents | $9.5 million | $15.5 million |
| Short-term Investments | $33.4 million | $0 |
| Accumulated Deficit | $193.2 million | $165.8 million |
| R&D Expenses | $15.5 million | $13.7 million |
Strategic Partnerships
Achieve Life Sciences recognizes the importance of strategic partnerships to enhance its capabilities and reach. Collaborating with organizations such as the National Institute on Drug Abuse (NIDA) has been pivotal in funding and supporting clinical trials. These partnerships are integral to fulfilling their vision of developing effective treatments for nicotine addiction.
Long-term Vision for Nicotine Cessation
Looking ahead, Achieve Life Sciences envisions a future where cytisinicline is a cornerstone in the treatment of nicotine dependence. With FDA Breakthrough Therapy designation awarded for cytisinicline, the company is poised to expedite its development and potentially improve the lives of millions. Achieve aims to establish itself as a leader in this critical area of public health, driving forward the mission to combat nicotine addiction effectively.
Core Values of Achieve Life Sciences, Inc. (ACHV)
Integrity
The core value of integrity is fundamental to Achieve Life Sciences, Inc. (ACHV). It underscores the importance of honesty and accountability in all business dealings. This value ensures that the company maintains a trustworthy relationship with stakeholders, including investors, employees, and patients.
In 2024, Achieve Life Sciences has demonstrated its commitment to integrity through transparent reporting of its financial status. As of September 30, 2024, the company reported an accumulated deficit of $193.2 million, with cash, cash equivalents, and short-term investments totaling $42.9 million. The detailed disclosure of financials reflects the company’s dedication to openness and ethical practices.
Innovation
Innovation is central to Achieve Life Sciences' mission to develop effective treatments for nicotine dependence. The company is focused on advancing its clinical programs, particularly the development of cytisinicline, a plant-based alkaloid aimed at aiding smoking cessation.
In 2024, Achieve Life Sciences reported a significant increase in research and development expenses, totaling $15.5 million for the nine months ended September 30, 2024, up from $13.7 million in the same period of 2023. This increase is attributed to the initiation of the ORCA-OL open-label safety trial, showcasing the company's commitment to innovative solutions for nicotine addiction.
Collaboration
Collaboration is a key value that Achieve Life Sciences embraces to enhance its research capabilities and expedite the development of its product candidates. The company collaborates with various academic institutions and research organizations to leverage expertise and resources.
For instance, Achieve Life Sciences partnered with Harvard Medical School for the ORCA-V1 clinical study, which received approximately $2.5 million in reimbursements from a NIDA/NIH grant. This collaboration not only strengthens the company's research initiatives but also exemplifies its commitment to working with leading experts to achieve shared goals.
Compassion
Compassion is at the heart of Achieve Life Sciences' mission to address the global nicotine addiction epidemic. The company is dedicated to improving the lives of individuals struggling with addiction through its innovative therapies.
In 2024, the company continues to focus on the significant public health issue of tobacco use, which is responsible for over 8 million deaths worldwide annually. By developing cytisinicline, Achieve aims to provide a new therapeutic option for those seeking to quit smoking and reduce the health risks associated with nicotine dependence.
Excellence
Achieve Life Sciences strives for excellence in all aspects of its operations, from research and development to regulatory compliance and commercialization efforts. This commitment to excellence drives the company to meet high standards in its clinical trials and product development processes.
As of September 30, 2024, Achieve reported total operating expenses of $26.9 million for the nine months ended September 30, 2024, reflecting a rigorous approach to maintaining quality and efficiency in its operations. The focus on excellence ensures that the company is well-positioned to meet the challenges of the pharmaceutical industry and deliver effective treatments to patients.
Achieve Life Sciences, Inc. (ACHV) DCF Excel Template
5-Year Financial Model
40+ Charts & Metrics
DCF & Multiple Valuation
Free Email Support
Updated on 16 Nov 2024
Resources:
- Achieve Life Sciences, Inc. (ACHV) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Achieve Life Sciences, Inc. (ACHV)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Achieve Life Sciences, Inc. (ACHV)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.