Achieve Life Sciences Files 2023 Annual Report on Form 10-K

TL;DR

<b>Achieve Life Sciences filed its 2023 10-K, detailing its operations and historical corporate changes.</b>

AI Summary

ACHIEVE LIFE SCIENCES, INC. (ACHV) filed a Annual Report (10-K) with the SEC on March 28, 2024. Achieve Life Sciences, Inc. filed its 2023 Form 10-K on March 28, 2024. The company was formerly known as OncoGenex Pharmaceuticals, Inc. and Sonus Pharmaceuticals Inc. The filing covers the fiscal year ending December 31, 2023. Key dates include a Share Purchase Agreement with Sopharma on May 14, 2015, and an Amendment to License Agreement with the University of Bristol on January 22, 2018. The company's business address is in Seattle, WA.

Why It Matters

For investors and stakeholders tracking ACHIEVE LIFE SCIENCES, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Achieve Life Sciences' financial performance and operational status for the fiscal year 2023, crucial for investors to assess the company's current standing. The historical name changes and past agreements mentioned in the filing offer context on the company's evolution and strategic partnerships.

Risk Assessment

Risk Level: low — ACHIEVE LIFE SCIENCES, INC. shows low risk based on this filing. The filing is a standard 10-K report with no immediate red flags, indicating a routine disclosure of financial and operational information.

Analyst Insight

Review the detailed financial statements and risk factors within the 10-K to understand Achieve Life Sciences' current financial health and future prospects.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-03-28 — Filing Date (FILED AS OF DATE)
• 2015-05-14 — Share Purchase Agreement Date (Sopharma)
• 2018-01-22 — License Agreement Amendment Date (University of Bristol)

Key Players & Entities

• ACHIEVE LIFE SCIENCES, INC. (company) — COMPANY CONFORMED NAME
• ACHV (company) — Ticker Symbol
• 20231231 (date) — CONFORMED PERIOD OF REPORT
• 20240328 (date) — FILED AS OF DATE
• OncoGenex Pharmaceuticals, Inc. (company) — FORMER COMPANY
• Sonus Pharmaceuticals Inc (company) — FORMER COMPANY
• Sopharma (company) — Partner in Share Purchase Agreement
• University of Bristol (company) — Partner in Amendment to License Agreement

FAQ

Industry Context

Achieve Life Sciences operates in the biotechnology sector, focusing on the development of therapies.

Regulatory Implications

The company is subject to standard SEC regulations for public companies, including the requirement to file annual reports like the 10-K.

What Investors Should Do

1. Analyze the financial statements for revenue, expenses, and cash flow.
2. Review any disclosed risk factors related to the company's operations or market.
3. Examine management's discussion and analysis for strategic insights.

Key Dates

• 2015-05-14: Share Purchase Agreement — Agreement with Sopharma
• 2018-01-22: Amendment to License Agreement — Agreement with University of Bristol
• 2023-12-31: Fiscal Year End — Period covered by the 10-K
• 2024-03-28: 10-K Filing Date — Date the report was filed with the SEC

Year-Over-Year Comparison

This is the company's 2023 annual report, providing updated financial and operational data compared to previous filings.

Key Financial Figures

• $0.001 — ch Registered Common Stock, par value $0.001 per share ACHV The Nasdaq Stock Mar

Filing Documents

• achv-20231231.htm (10-K) — 3073KB
• achv-ex10_10.htm (EX-10.10) — 48KB
• achv-ex10_21.htm (EX-10.21) — 169KB
• achv-ex10_32.htm (EX-10.32) — 91KB
• achv-ex21_1.htm (EX-21.1) — 3KB
• achv-ex23_1.htm (EX-23.1) — 3KB
• achv-ex31_1.htm (EX-31.1) — 11KB
• achv-ex32_1.htm (EX-32.1) — 5KB
• achv-ex97_0.htm (EX-97.0) — 79KB
• 0000950170-24-038049.txt (&nbsp;) — 12188KB
• achv-20231231.xsd (EX-101.SCH) — 1758KB
• achv-20231231_htm.xml (XML) — 2059KB

BUSINESS

BUSINESS 5 ITEM 1A.

RISK FACTORS

RISK FACTORS 21 ITEM 1B. UNRESOLVED STAFF COMMENTS 51 ITEM 1C. CYBERSECURITY 51 ITEM 2.

PROPERTIES

PROPERTIES 52 ITEM 3.

LEGAL PROCEEDINGS

LEGAL PROCEEDINGS 53 ITEM 4. MINE SAFETY DISCLOSURE 53 PART II 54 ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 54 ITEM 6. RESERVED 54 ITEM 7.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 55 ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 62 ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 63 ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 91 ITEM 9A.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 91 ITEM 9B. OTHER INFORMATION 91 ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 91 PART III 92 ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 92 ITEM 11.

EXECUTIVE COMPENSATION

EXECUTIVE COMPENSATION 92 ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 92 ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 92 ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 92 PART IV 93 ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 93 ITEM 16. FORM 10-K SUMMARY 98

SIGNATURES

SIGNATURES 98 P ART I References in this Form 10-K to "Achieve Life Sciences," "Achieve," the "Company," "we," "us" or "our" refer to Achieve Life Sciences, Inc. and its wholly owned subsidiaries. The information in this Annual Report on Form 10-K contains certain forward-looking statements, including statements related to clinical trials, regulatory approvals, markets for our products, new product development, capital requirements and trends in our business that involve risks and uncertainties. Our actual results may differ materially from the results discussed in the forward-looking statements. Factors that might cause such a difference include those discussed in "Business," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations," as well as those discussed elsewhere in this Annual Report on Form 10-K.

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve a number of risks and uncertainties. We caution readers that any forward-looking statement is not a guarantee of future performance and that actual results could differ materially from those contained in the forward-looking statement. These statements are based on current expectations of future events. Such statements include, but 2 are not limited to, statements about future financial and operating results, plans, objectives, expectations and intentions, costs and expenses, interest rates, outcome of contingencies, financial condition, results of operations, liquidity, business strategies, cost savings, objectives of management and other statements that are not historical facts. You can find many of these statements by looking for words like "believes," "expects," "anticipates," "estimates," "may," "should," "will," "could," "plan," "intend" or similar expressions in this Annual Report on Form 10-K or in documents incorporated by reference into this Annual Report on Form 10-K. We intend that such forward-looking statements be subject to the safe harbors created thereby. Examples of these forward-looking statements include, but are not limited to: progress and preliminary and future results of any clinical trials; anticipated regulatory filings and U.S. Food and Drug Administration, or FDA, responses, recommendations, requirements or additional future clinical trials; our ability to raise additional capital as needed to fund our planned development and commercialization efforts and repay our existing debt; the potential benefits and differentiated profile, FDA approval, commercialization and commercial market for cytisinicline; the performance of, and our ability to obtain sufficient supply of cytisinicline in a timely manner from, third-pa

View Full Filing

View this 10-K filing on SEC EDGAR