Achieve Life Sciences (ACHV) AI Stock Analysis

• Market Cap: $233.70M
• Dividend Yield: N/A
• Average Volume (3M): 598.74K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.90
• Revenue Growth: N/A
• EPS Growth: -22.06%
• Country: US
• Employees: 25
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.28
• Shares Outstanding: 53,233,990
• 10 Day Avg. Volume: 318,159
• 30 Day Avg. Volume: 598,735
• PEG Ratio: 0.16
• Price to Book (P/B): 5.40
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -3.79
• Enterprise Value/Market Cap: 0.96
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: -1.91K
• Enterprise Value/Ebitda: -4.36
• 1Y Price Target: $12.00
• Price Target Upside: 173.35% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 1
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 55 Neutral
• Price Target: $4.50 ▲(2.51% Upside)
• Action: Upgraded Date: 01/28/26
• Date: Action: Upgraded 01/28/26

The score is held back primarily by weak financial performance (no revenue, heavy losses, and significant cash burn), partially offset by a healthier balance sheet and a positive, catalyst-driven earnings call centered on NDA progress and expedited review potential. Technicals are mixed/neutral and valuation support is limited due to negative earnings.

Positive Factors

NDA acceptance and PDUFA date

NDA acceptance and a set PDUFA date materially advance the company from development to regulatory adjudication, reducing binary uncertainty. A defined approval timeline enables planning for manufacturing scale, payer engagements, and commercial investments that underpin sustained revenue potential post-approval.

Expedited review via priority voucher

Receiving a Commissioner's National Priority Voucher creates a structurally faster regulatory path for the vaping indication, potentially making Achieve first-to-market. This durable first-mover and timing advantage can shape formulary positioning, prescribing patterns, and long-term market share in a nascent vaping cessation segment.

Improved balance sheet and manageable leverage

Recovery to positive equity and relatively low debt provide lasting financial flexibility for a clinical-stage biotech. Manageable leverage lowers bankruptcy risk and supports near-term regulatory and commercialization spending without excessive reliance on high-cost debt, preserving strategic optionality during buildout.

Negative Factors

No revenue and ongoing cash burn

Zero product revenue and a sustained ~-$40.7M annual cash burn are structural constraints that force continual external financing until commercialization. Persistent losses erode capital, increase dilution risk, and limit ability to invest in commercial scale-up or ancillary programs without dilutive raises or partnerships.

Need for additional funding for vaping study

An explicit funding gap for the vaping study is a durable execution risk: raising capital can dilute existing shareholders, change capital allocation priorities, or delay study completion. Dependence on external financing complicates long-term planning and could impair timely market entry if markets tighten.

Commercial execution complexity from staggered launches

Staggered potential launches for vaping and smoking indications create structural commercialization challenges: separate go-to-market timing, messaging, supply chain and payer strategies increase operating complexity. For a small team, this raises sustained execution risk and incremental cost to capture both markets effectively.

Achieve Life Sciences Business Overview & Revenue Model

Company Description

Achieve 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 Money

Achieve 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 Financial Statement Overview

Summary

Income statement and cash flow are weak (no revenue, sizable net loss and ~-$40.7M TTM free cash flow burn), but the balance sheet is a relative positive with recovered positive equity (~$33.6M) and manageable debt (~$10.0M; ~0.30 debt-to-equity). Overall, funding dependence remains a key risk until commercialization.

Income Statement

TTM (Trailing-Twelve-Months) results show no revenue and continued heavy losses (net loss of about $52.3M; EBIT roughly -$52.3M), indicating the business remains in a pre-commercial/early-stage profile with limited operating leverage. Losses have widened versus 2023 and are also worse than 2024 annual levels, which points to a weaker near-term earnings trajectory. The main positive is that losses appear driven by operating spend rather than financial leverage, but profitability is still far from breakeven.

Balance Sheet

Balance sheet strength has improved meaningfully versus 2023, when equity was negative, to positive equity of about $33.6M in TTM (Trailing-Twelve-Months). Leverage looks manageable with total debt of about $10.0M and a debt-to-equity ratio around 0.30 (improved from ~0.48 in 2024 annual), suggesting the company is not overly debt-funded. The key weakness is still poor returns on equity due to ongoing net losses, and the company’s capital base could be pressured if losses persist.

Cash Flow

Cash generation remains weak with TTM (Trailing-Twelve-Months) operating cash flow and free cash flow both around -$40.7M, indicating a sizable cash burn that requires continued funding. Free cash flow improved versus 2024 annual (less negative), but it is still materially worse than 2023 levels, highlighting volatility and an elevated burn rate. A positive is that free cash flow broadly tracks net income (both negative), but the overall cash profile remains a central risk.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	0.00	0.00	0.00	0.00	0.00	0.00
Gross Profit	-117.00K	-229.00K	0.00	0.00	0.00	-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 Assets	52.04M	38.63M	19.37M	29.97M	47.52M	40.30M
Cash, Cash Equivalents and Short-Term Investments	48.11M	34.36M	15.55M	24.72M	43.02M	35.85M
Total Debt	9.96M	9.96M	16.73M	16.20M	14.99M	169.00K
Total Liabilities	18.43M	17.73M	20.82M	21.67M	19.47M	3.01M
Stockholders Equity	33.62M	20.90M	-1.45M	8.30M	28.04M	37.29M
Cash Flow
Free Cash Flow	-40.68M	-29.77M	-24.50M	-37.57M	-29.44M	-13.49M
Operating Cash Flow	-40.68M	-29.77M	-24.48M	-37.57M	-29.44M	-13.47M
Investing Cash Flow	17.12M	-21.58M	-21.00K	0.00	0.00	-17.00K
Financing Cash Flow	45.95M	48.53M	15.28M	19.32M	36.61M	32.68M

Achieve Life Sciences Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 4.39
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: 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 4.39 is above the 20-day moving average (MA) of 4.27, below the 50-day MA of 4.70, and above the 200-day MA of 3.71, indicating a neutral trend. The MACD of -0.15 indicates Negative momentum. The RSI at 47.69 is Neutral, neither overbought nor oversold. The STOCH value of 58.60 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for ACHV.

Achieve Life Sciences Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
ACHV	55 Neutral	$233.70M	-3.35	-161.08%	―	―	-22.06%
CLLS	54 Neutral	$295.12M	-12.53	-31.08%	―	158.54%	66.90%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
MIST	49 Neutral	$148.19M	-2.00	-260.65%	―	―	3.70%
SPRO	48 Neutral	$125.64M	-2.79	-95.29%	―	-67.38%	-1076.54%
NKTX	47 Neutral	$178.28M	-1.86	-26.69%	―	―	25.84%
IOBT	41 Neutral	$23.96M	-0.25	-240.48%	―	―	2.36%