Achieve Life Sciences, Inc.

NASDAQ•ACHV

CEO: Mr. Thomas B. King M.B.A.

Sector: Healthcare

Industry: Biotechnology

Listing Date: 1995-10-12

Achieve Life Sciences, Inc., a clinical-stage pharmaceutical company, develops and commercializes cytisinicline for smoking cessation and nicotine addiction. 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 and supply agreement with Sopharma AD and University of Bristol Achieve Life Sciences, Inc. is based in Vancouver, Canada.

Contact Information

1040 West Georgia Street, Suite 1030, Vancouver, BC, V6E 4H1, Canada

604-210-2217

www.achievelifesciences.com

Market Cap

$233.16M

P/E (TTM)

-2.9

17.4

Dividend Yield

52W High

$6.03

52W Low

$1.84

52W Range

61%

Rank66Top 96.8%

1.5

F-Score

Modified Piotroski Analysis

Based on 10-year fundamentals

Weak • 1.5 / 9 points

Scoring Range (0-9)

8-9: Excellent Value

6-7: Strong Fundamentals

4-5: Average Quality

0-3: Weak Performance

Data Period: 2016-2025

Financial Dashboard

Q3 2025 Data

Revenue

$0.00+0.00%

4-Quarter Trend

EPS

-$0.28-22.22%

4-Quarter Trend

FCF

-$11.33M+9.25%

4-Quarter Trend

2025 Q3 Earnings Highlights

Key Highlights

NDA Accepted Smoking Cessation FDA accepted NDA for cytisinicline smoking cessation; PDUFA date set for June 20, 2026.

CNPV Awarded Vaping Cessation Received CNPV for vaping cessation indication in October 2025, expediting FDA review process.

Strong Financing Bolsters Cash Net cash provided by financing was $45.3M for nine months ended September 30, 2025.

Total Assets Increased Significantly Total assets grew to $52.04M as of September 30, 2025, up from $38.63M at year-end 2024.

Risk Factors

Going Concern Uncertainty Exists Substantial doubt exists regarding ability to continue as going concern without substantial additional financing.

Increased Operating Loss Nine months ended September 30, 2025 net loss reached $40.0M, significantly higher than $27.5M loss prior year.

Sole Product Candidate Risk Business heavily dependent on cytisinicline success; regulatory approval or market acceptance is not guaranteed.

Third-Party Supply Dependence Commercialization relies on Sopharma supply agreement; disputes or failures could stop or delay product delivery.

Outlook

US Commercialization Planning Plan to commence commercial sales of cytisinicline in the US market during the second half of 2026.

Require Substantial Future Capital Current resources insufficient to fund operations for next 12 months; substantial capital raise needed soon.

Pursue Vaping Cessation Indication Will pursue Phase 3 study design for vaping cessation indication following FDA guidance on sNDA submission.

Increased Operating Expenses Expected Expect operating expenses to increase substantially while continuing clinical development and preparing for commercial stage.

Peer Comparison

Revenue (TTM)

VNDA

$216.11M

+8.7%

ARCT

$67.22M

-51.4%

VYGR

$40.37M

-49.5%

Gross Margin (Latest Quarter)

APLT

100.0%

+0.0pp

VNDA

93.3%

+0.1pp

VYGR

93.2%

+0.0pp

Key Metrics

Symbol	Market Cap	P/E (TTM)	ROE (TTM)	Debt to Assets
CAPR	$1.53B	-18.7	-71.0%	11.5%
ALLO	$591.04M	-2.8	-57.8%	19.4%
VNDA	$549.11M	-2.5	-49.2%	2.6%

Long-Term Trends

Last 4 Quarters

Revenue

Net Income

Operating Cash Flow

4Q Revenue CAGR

N/M

Revenue Volatile

4Q Net Income CAGR

N/M

Profitability Shift

Cash Flow Stability

Cash Flow Needs Attention

Deep Research

Next earnings:May 11, 2026

EPS:-

Revenue:-

Financials

Earnings Calls

Reports

News

Income Statement

Balance Sheet

Cash Flow Statement

Ratios

% Chg.

Income Statement	LTM

No Data