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ACHV

Achieve Life Sciences, Inc.

ACHV

Achieve Life Sciences, Inc. • NASDAQ
$4.87 ▲ 0.62% (+0.03)
Market Cap $259.20 M
52w High $5.78
52w Low $1.84
Dividend Yield 0%
P/E -3.61
Volume 253.63K
Outstanding Shares 53.22M

Income Statement

Period Revenue Operating Expense Net Income Net Profit Margin Earnings Per Share EBITDA
Q3-2025 $0 $14.692M ▲ $-14.441M ▼ 0% $-0.28 ▲ $-14.194M ▼
Q2-2025 $0 $12.563M ▼ $-12.718M ▲ 0% $-0.37 $-12.472M ▲
Q1-2025 $0 $12.894M ▲ $-12.827M ▼ 0% $-0.37 ▼ $-12.58M ▼
Q4-2024 $0 $12.19M ▼ $-12.36M ▲ 0% $-0.36 $-12.105M ▼
Q3-2024 $0 $12.466M $-12.512M 0% $-0.36 $-12.089M

Balance Statement

Period Cash & Short-term Total Assets Total Liabilities Total Equity
Q3-2025 $48.114M ▼ $52.04M ▼ $18.425M ▲ $33.615M ▼
Q2-2025 $55.397M ▲ $58.935M ▲ $17.267M ▲ $41.668M ▲
Q1-2025 $23.245M ▼ $27.358M ▼ $17.079M ▼ $10.279M ▼
Q4-2024 $34.34M ▼ $38.633M ▼ $17.734M ▲ $20.899M ▼
Q3-2024 $42.911M $47.917M $16.539M $31.378M

Cash Flow Statement

Period Net Income Cash From Operations Cash From Investing Cash From Financing Net Change Free Cash Flow
Q3-2025 $-14.441M ▼ $-11.331M ▼ $-12.654M ▼ $4.042M ▼ $-19.944M ▼ $-11.331M ▼
Q2-2025 $-12.718M ▲ $-9.069M ▲ $6.703M ▼ $41.222M ▲ $38.858M ▲ $-9.069M ▲
Q1-2025 $-12.827M ▼ $-11.088M ▼ $11.353M ▼ $0 ▼ $263K ▼ $-11.088M ▼
Q4-2024 $-12.36M ▲ $-9.189M ▲ $11.717M ▼ $682K ▲ $3.209M ▲ $-9.189M ▲
Q3-2024 $-12.512M $-10.372M $13.271M $-8.112M $-5.212M $-10.372M

Five-Year Company Overview

Income Statement

Income Statement Achieve is still a pure research‑stage company, so it has not generated any product revenue over the past several years. All of its spending shows up as research, development, and overhead costs, which result in steady losses each year. Those losses have been fairly consistent, not exploding higher, and there are signs they have narrowed somewhat more recently as major late‑stage trials wrapped up. This pattern is very typical for a small biotech that is funding long, expensive clinical programs before any drug is approved or sold.

Balance Sheet

Balance Sheet The company runs with a small balance sheet and limited resources. Cash makes up most of its assets, which is common for a biotech without manufacturing or large physical operations. Debt has appeared in recent years, adding a layer of financial obligation that did not exist before. Shareholders’ equity has been thin and has moved around, reflecting ongoing losses and periodic funding events. The history of multiple reverse stock splits suggests Achieve has relied heavily on equity markets over time and has had to manage a low share price. Overall, the balance sheet is workable for a development‑stage company but not robust, and it depends on continued access to fresh capital.

Cash Flow

Cash Flow Achieve consistently uses cash rather than generates it. Operating cash flow is negative each year, driven mainly by research and development and corporate overhead. There is essentially no spending on long‑term physical assets, so free cash flow looks very similar to operating cash flow. The cash burn has been steady rather than sharply accelerating, but the business clearly relies on external financing—equity raises, partnerships, or borrowing—to keep funding trials and corporate activities until any drug approval and commercialization occur.

Competitive Edge

Competitive Edge Achieve is trying to carve out a clear position in smoking and nicotine cessation, centered on a single lead asset, cytisinicline. The company benefits from strong clinical data, a differentiated plant‑based profile, and a sizable unmet medical need, especially in vaping cessation where there are currently no approved treatments. Its patent portfolio and long‑dated exclusivity on specific dosing regimens help create legal barriers for competitors. The focus on the “varenilcine gap” and vaping gives it a strategic angle versus older therapies and generic products. However, the company is still small, pre‑commercial, and concentrated in one main program, which leaves it exposed to larger pharmaceutical competitors, reimbursement pressures, and any unexpected safety, regulatory, or commercial challenges.

Innovation and R&D

Innovation and R&D R&D is the core of Achieve’s story. The company has advanced cytisinicline through a robust Phase 3 program in smoking cessation, with results published in a top medical journal, which adds scientific credibility. The drug’s dual‑action mechanism and relatively favorable tolerability profile are meaningful scientific advantages that may support real‑world use if approved. Achieve is also pushing into vaping cessation, including an FDA Breakthrough Therapy designation, which can speed interactions with regulators. On top of that, the company is working on a synthetic version of cytisinicline to strengthen intellectual property and improve manufacturing. The flip side is that so much value is tied to this one program and to regulatory decisions; any setbacks in approval, safety, or commercialization would directly hit the entire R&D thesis.

Summary

Achieve Life Sciences is a classic late‑stage biotech: no revenue yet, ongoing but relatively controlled losses, and a balance sheet that is adequate for now but clearly dependent on future capital. The investment case revolves almost entirely around cytisinicline and its potential to reshape smoking and vaping cessation treatment. The company has built a credible scientific and intellectual property platform and is approaching a pivotal regulatory milestone in the United States. At the same time, it faces the usual high uncertainties of drug approval, commercialization execution, competition from existing therapies and generics, and the need to keep funding operations until cash flows can turn positive. The coming regulatory decisions and trial results will largely determine whether Achieve can successfully transition from a research‑only entity to a sustainable commercial business.

NEWS

November 6, 2025 · 7:00 AM UTC

Achieve Life Sciences Reports Third Quarter 2025 Financial Results; Provides Updates on Cytisinicline Program

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November 3, 2025 · 8:30 AM UTC

Achieve Life Sciences Meets Key Milestones Advancing Cytisinicline NDA for Smoking Cessation

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October 29, 2025 · 8:30 AM UTC

Achieve Life Sciences to Announce Third Quarter Financial Results and Host Conference Call and Webcast on November 6, 2025

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October 20, 2025 · 8:30 AM UTC

Achieve Life Sciences Appoints Erik Atkisson as Chief Legal Officer

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October 17, 2025 · 7:30 AM UTC

Achieve Life Sciences Receives FDA Commissioner's National Priority Voucher for Cytisinicline for Treatment of Nicotine Dependence for E-cigarette or Vaping Cessation

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