tiprankstipranks
Trending News
More News >
Achieve Life Sciences Inc (ACHV)
NASDAQ:ACHV
Advertisement

Achieve Life Sciences (ACHV) AI Stock Analysis

Compare
1,698 Followers

Top Page

ACHV

Achieve Life Sciences

(NASDAQ:ACHV)

Select Model
Select Model
Select Model
Underperform 37 (OpenAI - 4o)
Rating:37Underperform
Price Target:
Achieve Life Sciences is navigating typical early-stage biotech challenges, including zero revenue and significant financial losses. While there are promising developments such as the upcoming NDA submission and strong clinical trial progress, these are offset by high operating expenses and dependency on future financing and regulatory approvals. Technical indicators reflect a downward trend, and the valuation remains unattractive with a negative P/E ratio.
Positive Factors
Clinical Trial Progress
Successful clinical trials demonstrate the efficacy and safety of cytisinicline, positioning Achieve Life Sciences favorably for NDA submission and potential market entry, which could significantly enhance revenue prospects.
Financial Health
Improved financial health with increased cash reserves provides a buffer to support ongoing operations and R&D activities, reducing immediate financial risk and enabling strategic investments in drug development.
Leadership Strengthening
Strengthening the leadership team with experienced professionals enhances strategic decision-making and governance, potentially improving operational efficiency and execution of growth strategies.
Negative Factors
High Operating Expenses
High operating expenses contribute to ongoing financial losses, which may necessitate further capital raising and could delay profitability, impacting the company's long-term financial sustainability.
Dependence on FDA Approval
Reliance on FDA approval introduces regulatory risk, as any delays or rejections could significantly impact the company's ability to commercialize its lead product and achieve revenue generation.
Challenges in Vaping Cessation
Financing challenges for the vaping cessation trial could delay product development and market entry, affecting the company's ability to diversify its product pipeline and revenue streams.

Achieve Life Sciences (ACHV) vs. SPDR S&P 500 ETF (SPY)

Achieve Life Sciences Business Overview & Revenue Model

Company DescriptionAchieve Life Sciences, Inc., a clinical-stage pharmaceutical company, develops and commercializes of cytisinicline for smoking cessation and nicotine addiction in Canada, the United States, and the United Kingdom. The company offers cytisinicline, a plant-based alkaloid that interacts with nicotine receptors in the brain that reduce the severity of nicotine withdrawal symptoms. It has license agreements with Sopharma AD and University of Bristol. The company is based in Vancouver, Canada.
How the Company Makes MoneyAchieve Life Sciences generates revenue primarily through the development and potential future commercialization of its lead product, cytisinicline, which is currently in clinical trials. The company aims to earn income from the successful approval and sale of cytisinicline, targeting partnerships, licensing agreements, and collaborations with larger pharmaceutical companies to aid in distribution and marketing. Additionally, Achieve seeks funding through public and private investments to support its research and development activities. As it is still in the clinical stage, the company's current revenues are limited, and its financial strategy relies on securing further investment and eventual drug approval for market entry.

Achieve Life Sciences Earnings Call Summary

Earnings Call Date:Nov 06, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Mar 12, 2026
Earnings Call Sentiment Positive
The earnings call highlighted significant regulatory achievements and strategic advancements, particularly in gaining an expedited review for vaping cessation. However, funding needs for further clinical trials and challenges in aligning commercial strategies for two different market entries pose potential risks.
Q3-2025 Updates
Positive Updates
FDA Priority Voucher for Vaping Indication
Achieve Life Sciences received a Commissioner's National Priority Voucher from the FDA for cytisinicline in vaping cessation, allowing for expedited NDA review and potential early market entry.
Regulatory Milestones Achieved
FDA accepted the NDA for cytisinicline for smoking cessation with a PDUFA date set for June 20, 2026. A 120-day safety review was also submitted on time.
Positive Outcomes from COPD Studies
Smokers with COPD had higher quit rates on cytisinicline compared to placebo in Phase III trials, indicating cytisinicline's potential to aid a difficult-to-treat population.
Commercial Strategy and AI Integration
Achieve is integrating AI-driven tools for precision targeting in its commercialization strategy, enhancing engagement and optimizing resource allocation.
Strong Financial Position
As of September 30, 2025, Achieve had $48.1 million in cash, cash equivalents, and marketable securities, with a cash runway extending into the second half of 2026.
Negative Updates
Need for Additional Funding
Additional capital will be required to fund the vaping study, as current resources do not cover this expense.
Challenges in Market Entry Timing
The potential launch of cytisinicline for vaping may occur earlier than the smoking cessation launch, posing challenges in aligning commercial infrastructure.
Company Guidance
During the Achieve Life Sciences Third Quarter 2025 Earnings Conference Call, significant advancements were highlighted regarding the company's primary objectives, particularly the NDA submission, acceptance, and anticipated approval for cytisinicline, a treatment aimed at nicotine dependence and smoking cessation. A notable achievement was the FDA's award of a Commissioner's National Priority Voucher (CNPV) for the e-cigarette or vaping indication, expediting the NDA review timeline to 1-2 months from the standard 10-12 months. This expedited timeline could potentially see the launch of cytisinicline 8 months earlier, positioning it as the first FDA-approved treatment for the 60% of people desiring to quit vaping. The FDA has set a PDUFA date of June 20, 2026, for the smoking cessation indication, following the acceptance of the NDA and the timely submission of a 120-day safety review. Additionally, the company has emphasized its data-driven digital commercialization strategy, leveraging AI and machine learning to optimize engagement across healthcare professionals, patients, and payers, ensuring a robust and targeted launch strategy for cytisinicline.

Achieve Life Sciences Financial Statement Overview

Summary
Achieve Life Sciences faces challenges typical of early-stage biotech firms, with no revenue, significant losses, and negative cash flows. Improvements in equity and financing inflows offer some stability, but the company remains in a precarious financial position until it can generate consistent revenue streams.
Income Statement
15
Very Negative
Achieve Life Sciences has consistently reported zero revenue, indicating a lack of commercialized products or services. The company has also experienced significant net losses over the years, including a net loss of $39.83 million in 2024. This trend highlights the financial challenges typical in the biotechnology industry during the R&D phase.
Balance Sheet
30
Negative
The company's debt-to-equity ratio improved significantly in 2024 due to increased stockholders' equity from negative to $20.9 million. However, the company still carries a notable amount of debt relative to its equity. The equity ratio of 54.1% in 2024 suggests a moderate reliance on equity financing, yet the previous negative equity poses potential risks.
Cash Flow
20
Very Negative
Achieve Life Sciences shows negative operating and free cash flows, consistent with its developmental stage. The operating cash flow to net income ratio indicates cash outflows are aligned with reported losses. While financing activities have provided substantial cash inflows, the negative free cash flow growth highlights ongoing cash burn.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue0.000.000.000.000.000.00
Gross Profit-117.00K-229.00K0.000.000.00-255.00K
EBITDA-51.35M-37.42M-26.73M-40.33M-32.90M-14.47M
Net Income-52.35M-39.83M-29.82M-42.35M-33.15M-14.66M
Balance Sheet
Total Assets52.04M38.63M19.37M29.97M47.52M40.30M
Cash, Cash Equivalents and Short-Term Investments48.11M34.36M15.55M24.72M43.02M35.85M
Total Debt9.96M9.96M16.73M16.20M14.99M169.00K
Total Liabilities18.43M17.73M20.82M21.67M19.47M3.01M
Stockholders Equity33.62M20.90M-1.45M8.30M28.04M37.29M
Cash Flow
Free Cash Flow-40.68M-29.77M-24.50M-37.55M-29.46M-13.49M
Operating Cash Flow-40.68M-29.77M-24.48M-37.55M-29.44M-13.47M
Investing Cash Flow17.12M-21.58M-21.00K0.00-17.00K-17.00K
Financing Cash Flow45.95M48.53M15.28M19.30M36.61M32.68M

Achieve Life Sciences Technical Analysis

Technical Analysis Sentiment
Positive
Last Price4.77
Price Trends
50DMA
3.72
Positive
100DMA
3.21
Positive
200DMA
3.06
Positive
Market Momentum
MACD
0.31
Positive
RSI
58.08
Neutral
STOCH
29.15
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For ACHV, the sentiment is Positive. The current price of 4.77 is above the 20-day moving average (MA) of 4.69, above the 50-day MA of 3.72, and above the 200-day MA of 3.06, indicating a bullish trend. The MACD of 0.31 indicates Positive momentum. The RSI at 58.08 is Neutral, neither overbought nor oversold. The STOCH value of 29.15 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ACHV.

Achieve Life Sciences Risk Analysis

Achieve Life Sciences disclosed 65 risk factors in its most recent earnings report. Achieve Life Sciences reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks

Achieve Life Sciences Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
51
Neutral
$238.25M-31.07%158.54%66.90%
48
Neutral
$140.69M-94.59%-67.67%-390.60%
43
Neutral
$57.69M-212.51%-9.69%
39
Underperform
$139.22M-26.69%25.84%
39
Underperform
$157.24M-780.29%20.13%
37
Underperform
$244.34M-161.08%-22.06%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
ACHV
Achieve Life Sciences
4.77
0.24
5.30%
CLLS
Cellectis SA
3.72
1.74
87.88%
SPRO
Spero Therapeutics
2.62
1.31
100.00%
MIST
Milestone Pharmaceuticals
1.91
0.07
3.80%
NKTX
Nkarta
2.01
-0.90
-30.93%
IOBT
IO Biotech
0.87
-0.10
-10.31%

Achieve Life Sciences Corporate Events

Executive/Board Changes
Achieve Life Sciences Announces Board of Directors Changes
Neutral
Jan 10, 2025

Achieve Life Sciences announced changes in its board of directors with the resignation of Dr. Vaughn Himes and the appointment of Nancy R. Phelan and Kristen B. Slaoui. The new directors will receive compensation in line with the company’s non-employee director compensation program and are granted stock options with vesting conditions tied to their continued service.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Apr 21, 2025