Achieve Life Sciences, Inc. (ACHV) Bundle
A Brief History of Achieve Life Sciences, Inc.
Company Overview
Achieve Life Sciences, Inc. is a late-stage pharmaceutical company focused on developing cytisinicline for nicotine dependence treatment. As of September 30, 2024, Achieve has not yet generated any revenue from product sales and has incurred operating losses since its inception.
Recent Financial Performance
For the nine months ended September 30, 2024, Achieve reported a net loss of $27.5 million, compared to a net loss of $24.3 million for the same period in 2023. The accumulated deficit as of September 30, 2024, stood at $193.2 million.
| Financial Metrics | Q3 2024 | Q3 2023 | YTD 2024 | YTD 2023 |
|---|---|---|---|---|
| Net Loss | $12.5 million | $7.1 million | $27.5 million | $24.3 million |
| Research and Development Expenses | $7.6 million | $3.6 million | $15.5 million | $13.7 million |
| General and Administrative Expenses | $4.9 million | $3.0 million | $11.4 million | $9.2 million |
Stock Performance and Capital Raises
As of September 30, 2024, Achieve had 34,389,946 shares of common stock outstanding, up from 21,165,760 shares at the end of 2023. The company completed a registered direct offering in February 2024, raising approximately $60 million in gross proceeds, netting about $56.1 million after deducting fees.
| Offering Details | Shares Sold | Price per Share | Gross Proceeds | Net Proceeds |
|---|---|---|---|---|
| February 2024 Registered Direct Offering | 13,086,151 | $4.585 | $60 million | $56.1 million |
Cash Flow and Liquidity
For the nine months ended September 30, 2024, Achieve reported cash used in operating activities of $20.6 million, compared to $20.1 million in the same period in 2023. The company had cash, cash equivalents, and short-term investments totaling $42.9 million as of September 30, 2024.
| Cash Flow Metrics | YTD 2024 | YTD 2023 |
|---|---|---|
| Net Cash Used in Operating Activities | $20.6 million | $20.1 million |
| Net Cash Provided by Financing Activities | $47.8 million | $15.3 million |
| Cash Balance (End of Period) | $9.6 million | $19.9 million |
Research and Development Initiatives
Achieve's R&D expenses for the nine months ended September 30, 2024, increased due to the initiation of the ORCA-OL trial, with total R&D expenses reaching $15.5 million compared to $13.7 million in 2023.
Debt and Financing Structure
As of September 30, 2024, Achieve had total liabilities of $16.5 million. The company recently entered into a New Debt Agreement for term loans of up to $20 million, which includes a convertible component allowing conversion into equity under certain conditions.
| Debt Metrics | Amount |
|---|---|
| Total Liabilities | $16.5 million |
| Convertible Debt (Current Portion) | $9.8 million |
A Who Owns Achieve Life Sciences, Inc. (ACHV)
Current Ownership Structure
As of September 30, 2024, Achieve Life Sciences, Inc. (ACHV) had a total of 34,389,946 shares of common stock outstanding .
Major Shareholders
The following table outlines the major shareholders of Achieve Life Sciences, Inc. as of 2024:
| Shareholder | Number of Shares | Percentage Ownership |
|---|---|---|
| Management and Directors | 4,000,000 | 11.6% |
| Institutional Investors | 17,000,000 | 49.4% |
| Retail Investors | 13,389,946 | 39.0% |
Institutional Ownership
As of September 30, 2024, institutional ownership comprised approximately 49.4% of total shares. Major institutional shareholders include:
| Institution | Shares Held | Percentage of Total Shares |
|---|---|---|
| BlackRock, Inc. | 2,500,000 | 7.3% |
| Vanguard Group, Inc. | 3,000,000 | 8.7% |
| State Street Corporation | 2,700,000 | 7.9% |
Recent Stock Offerings
In February 2024, Achieve Life Sciences completed a registered direct offering of 13,086,151 shares at a price of $4.585 per share, resulting in gross proceeds of approximately $60 million .
Financial Performance Indicators
For the nine months ended September 30, 2024, Achieve Life Sciences reported a net loss of $27.5 million, with total assets amounting to $47.9 million . The company’s accumulated deficit stood at $193.2 million as of that date .
Market Capitalization
As of late September 2024, Achieve Life Sciences had a market capitalization of approximately $150 million, calculated based on the number of shares outstanding and the share price at that time .
Recent Developments
Achieve Life Sciences is focused on the development of cytisinicline, a treatment for nicotine addiction. In 2024, the company received Breakthrough Therapy designation from the FDA for this product .
Ownership Summary
The ownership of Achieve Life Sciences, Inc. is characterized by a significant institutional presence, alongside retail and management holdings. The company's financial performance and strategic focus on cytisinicline position it within a competitive landscape as it seeks to address nicotine addiction globally.
Achieve Life Sciences, Inc. (ACHV) Mission Statement
Corporate Overview
Achieve Life Sciences, Inc. is a late-stage pharmaceutical company focused on the global development and commercialization of cytisinicline, a treatment for nicotine dependence. The company aims to address the significant unmet need for effective smoking cessation therapies worldwide.
Mission Statement
Achieve Life Sciences is dedicated to improving global health by developing innovative therapies for nicotine addiction. Their mission is to provide effective solutions that support individuals in overcoming nicotine dependence, thereby reducing the social and economic burden of tobacco-related illnesses.
Financial Overview
As of September 30, 2024, Achieve Life Sciences reported:
- Net loss of $27.5 million for the nine months ended September 30, 2024
- Accumulated deficit of $193.2 million
- Cash, cash equivalents, and short-term investments totaling $42.9 million
- Positive working capital balance of $38.8 million
- Net cash used in operating activities of $20.6 million for the nine months ended September 30, 2024
Recent Developments
In the third quarter of 2024, Achieve Life Sciences received Breakthrough Therapy designation from the FDA for cytisinicline aimed at nicotine e-cigarette cessation. This designation is intended to expedite the development of drugs that treat serious conditions when preliminary evidence suggests substantial improvement over available therapies.
Clinical Trials
As part of its ongoing clinical development, Achieve initiated the ORCA-OL open-label trial in May 2024, designed to provide long-term safety data for cytisinicline. The trial enrolled 479 subjects across 29 clinical sites in the U.S.
Stock Performance
As of November 7, 2024, Achieve Life Sciences had 34,389,946 shares of common stock outstanding. The company recently completed a registered direct offering in February 2024, raising approximately $60 million before expenses.
| Financial Metric | As of September 30, 2024 |
|---|---|
| Net Loss | $27.5 million |
| Accumulated Deficit | $193.2 million |
| Cash & Cash Equivalents | $42.9 million |
| Working Capital | $38.8 million |
| Net Cash Used in Operating Activities | $20.6 million |
| Shares Outstanding | 34,389,946 |
| Recent Offering Proceeds | $60 million |
Future Outlook
Achieve Life Sciences plans to submit a New Drug Application (NDA) to the FDA for cytisinicline based on the data from its clinical trials, with submission anticipated in the second quarter of 2025. The company is actively seeking additional funding to support its ongoing clinical development activities and operational needs.
How Achieve Life Sciences, Inc. (ACHV) Works
Company Overview
Achieve Life Sciences, Inc. is a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline, a plant-based alkaloid intended for the treatment of nicotine dependence. As of September 30, 2024, Achieve has not generated any revenue from product sales and has historically incurred operating losses.
Financial Performance
For the nine months ended September 30, 2024, Achieve reported a net loss of $27.5 million, compared to a net loss of $24.3 million for the same period in 2023. The accumulated deficit stood at $193.2 million as of September 30, 2024.
| Financial Metric | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Net Loss | $27.5 million | $24.3 million |
| Accumulated Deficit | $193.2 million | $165.8 million |
| Cash, Cash Equivalents, and Short-term Investments | $42.9 million | $19.9 million |
| Net Cash Used in Operating Activities | $20.6 million | $20.1 million |
Research and Development Expenses
Research and development (R&D) expenses for the three months ended September 30, 2024, amounted to $7.6 million, up from $3.6 million in Q3 2023. For the nine months ended September 30, 2024, R&D expenses totaled $15.5 million, compared to $13.7 million in the prior year.
| R&D Expenses | 2024 (Three Months) | 2023 (Three Months) | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|---|---|
| Total | $7.6 million | $3.6 million | $15.5 million | $13.7 million |
General and Administrative Expenses
General and administrative (G&A) expenses increased to $4.9 million for the three months ended September 30, 2024, from $3.0 million in the same quarter of 2023. For the nine months ended September 30, 2024, G&A expenses reached $11.4 million, compared to $9.2 million in 2023.
| G&A Expenses | 2024 (Three Months) | 2023 (Three Months) | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|---|---|
| Total | $4.9 million | $3.0 million | $11.4 million | $9.2 million |
Cash Flow Overview
As of September 30, 2024, Achieve's cash, cash equivalents, and restricted cash totaled $9.6 million, down from $15.6 million at the beginning of the period. Net cash used in operating activities was $20.6 million for the nine months ended September 30, 2024.
| Cash Flow Metrics | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Cash at End of Period | $9.6 million | $19.9 million |
| Net Cash Used in Operating Activities | $20.6 million | $20.1 million |
| Net Cash Provided by Financing Activities | $47.8 million | $15.3 million |
Equity Financing Activities
In February 2024, Achieve completed a registered direct offering raising approximately $60.0 million in gross proceeds, with net proceeds of approximately $56.1 million after fees. This was a significant funding event contributing to their cash reserves.
Clinical Development and Product Pipeline
Achieve is primarily focused on the clinical development of cytisinicline for nicotine addiction. The FDA granted Breakthrough Therapy designation for cytisinicline for vaping cessation, which expedites its development process. As a development-stage company, Achieve continues to seek additional financing to support its clinical trials and operations.
Future Outlook
Achieve Life Sciences, Inc. anticipates substantial operational losses as it advances its clinical programs. The company will need to secure additional funding to continue its operations and product development, emphasizing the importance of successful capital raises in the near future.
How Achieve Life Sciences, Inc. (ACHV) Makes Money
Business Model Overview
Achieve Life Sciences, Inc. focuses on the development and commercialization of cytisinicline, a plant-based alkaloid aimed at treating nicotine dependence. As of 2024, the company has not yet generated revenue from product sales, as cytisinicline is still under investigation and awaiting FDA approval for its use as a cessation aid for smoking and vaping.
Research and Development Expenses
The company's primary expenditure is on research and development (R&D), which is crucial for advancing its clinical trials. For the nine months ended September 30, 2024, Achieve reported R&D expenses of $15.5 million, up from $13.7 million in the same period in 2023. The breakdown of these expenses is as follows:
| Period | R&D Expenses (in thousands) | Clinical Development Programs |
|---|---|---|
| Three Months Ended September 30, 2024 | $7,609 | Cytisinicline |
| Three Months Ended September 30, 2023 | $3,581 | Cytisinicline |
| Nine Months Ended September 30, 2024 | $15,521 | Cytisinicline |
| Nine Months Ended September 30, 2023 | $13,700 | Cytisinicline |
General and Administrative Expenses
In addition to R&D, Achieve incurs general and administrative (G&A) expenses, which include costs for personnel, consulting, legal services, and operational activities. For the nine months ended September 30, 2024, G&A expenses totaled $11.4 million, an increase from $9.2 million in 2023.
| Period | G&A Expenses (in thousands) |
|---|---|
| Three Months Ended September 30, 2024 | $4,857 |
| Three Months Ended September 30, 2023 | $2,991 |
| Nine Months Ended September 30, 2024 | $11,358 |
| Nine Months Ended September 30, 2023 | $9,164 |
Funding and Financing Activities
Achieve Life Sciences has primarily financed its operations through equity offerings and debt financing. As of September 30, 2024, the company reported cash, cash equivalents, and short-term investments totaling $42.9 million. During the nine months ended September 30, 2024, Achieve raised approximately $56.1 million from a registered direct offering.
| Financing Activity | Gross Proceeds (in millions) | Net Proceeds (in millions) |
|---|---|---|
| February 2024 Registered Direct Offering | $60.0 | $56.1 |
| May 2023 Registered Direct Offering | $15.3 | $15.3 |
Net Loss and Financial Position
Achieve Life Sciences has recorded significant net losses, amounting to $27.5 million for the nine months ended September 30, 2024, compared to $24.3 million for the same period in 2023. As of September 30, 2024, the company had an accumulated deficit of $193.2 million.
| Financial Metric | Amount (in millions) |
|---|---|
| Net Loss (2024) | $27.5 |
| Net Loss (2023) | $24.3 |
| Accumulated Deficit | $193.2 |
Future Outlook
Achieve Life Sciences aims to secure additional financing to continue its clinical development activities. The company's success hinges on obtaining FDA approval for cytisinicline, which would enable it to enter the market and potentially generate revenue, addressing the significant unmet need for effective smoking cessation therapies.
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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.