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Achieve Life Sciences, Inc. (ACHV) SEC Filing 10-K Annual Report for the fiscal year ending Friday, December 31, 2021

SEC Filings

Achieve Life Sciences, Inc.

CIK: 949858 Ticker: ACHV

Exhibit 99.1

 

 

Achieve Life Sciences Reports Financial Results for Fourth Quarter and Year-End 2021 and Provides Corporate Update

 

Company to host conference call at 4:30 PM EST today, March 10, 2022

 

SEATTLE, Wash and VANCOUVER, British Columbia, March 10, 2022 — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, today announced fourth quarter and year-end 2021 financial results and provided an update on the cytisinicline clinical development program.

 

Recent Business Highlights

 

Initiated ORCA-3, the second Phase 3 trial, in 750 adult smokers at 15 clinical sites in the United States

 

Announced last subject and last follow-up visit in the Phase 3 ORCA-2 trial of cytisinicline for smoking cessation

 

Entered into a $25 million loan facility with Silicon Valley Bank 

 

Facilitated Key Opinion Leader virtual roundtable on smoking and e-cigarette cessation

 

Received U.S. Food and Drug Administration (FDA) acceptance of Investigational New Drug (IND) application for investigation of cytisinicline as a treatment for nicotine e-cigarette/vaping cessation 

 

“We finished 2021 strong achieving multiple milestones and are starting the new year off with continued momentum in the cytisinicline development program,” commented John Bencich, Chief Executive Officer of Achieve. “We are eagerly anticipating topline results from the Phase 3 ORCA-2 trial in the coming months, as we enroll smokers in the recently initiated Phase 3 ORCA-3 trial at 15 clinical sites in the United States. Additionally, our cash position remains strong with funding into 2023, allowing us to execute on the final stages of clinical development needed to support an NDA for smoking cessation.” 

 

Phase 3 ORCA-3 Trial Initiated

Achieve announced it has initiated enrollment for the Phase 3 ORCA-3 trial at 15 clinical sites in the United States in January 2022. Similar to the ORCA-2 trial, ORCA-3 will evaluate the efficacy and safety of 3 mg cytisinicline dosed three times daily compared to placebo.  Approximately 750 smokers will be randomized to one-of-three treatment arms to evaluate cytisinicline administered for either 6 or 12 weeks.  

 

Phase 3 ORCA-2 Trial Completed Last Subject and Last Follow-up Visit 


The following information was filed by Achieve Life Sciences, Inc. (ACHV) on Thursday, March 10, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Achieve Life Sciences, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Loss And Comprehensive Loss
Consolidated Statements Of Stockholder's Equity
Accounting Policies
Accounting Policies (Policies)
Accounting Policies (Tables)
Accounting Policies - Additional Information (Detail)
Accounting Policies - Summary Of Depreciation On Property And Equipment (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Summary Of Contractual Obligations (Detail)
Commitments And Contingencies - Summary Of Future Minimum Annual Lease Payments (Detail)
Commitments And Contingencies - Summary Of Other Information Related To Leases (Detail)
Common Stock
Common Stock (Tables)
Common Stock - Authorized - Additional Information (Detail)
Common Stock - Computation Of Basic And Diluted Net Loss Attributable To Common Shareholders Per Share (Detail)
Common Stock - Issued And Outstanding Shares - Additional Information (Detail)
Common Stock - Loss Per Common Share - Additional Information (Detail)
Common Stock - Restricted Stock Unit Awards - Additional Information (Detail)
Common Stock - Stock Options - Additional Information (Detail)
Common Stock - Stock Warrants - Additional Information (Detail)
Common Stock - Summary Of Fair Value Of Option Awards (Detail)
Common Stock - Summary Of Outstanding Warrants (Detail)
Common Stock - Summary Of Restricted Stock Unit Award Activity (Detail)
Common Stock - Summary Of Share-Based Compensation Expense (Detail)
Common Stock - Summary Of Stock Options Activity (Detail)
Common Stock - Summary Of Stock Options Outstanding Regarding Number Of Common Shares Issuable Upon Exercise Of Outstanding Options (Detail)
Common Stock - Summary Of Stock Options Outstanding Regarding Number Of Common Shares Issuable Upon Exercise Of Vested Options (Detail)
Convertible Debt
Convertible Debt (Tables)
Convertible Debt - Additional Information (Details)
Convertible Debt - Schedule Of Convertible Debt Balance (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Additional Information (Detail)
Fair Value Measurements - Schedule Of Aggregate Fair Value Of Principal Amount Of Convertible Debt (Detail)
Fair Value Measurements - Summary Of Assets And Liabilities Measured At Fair Value On Recurring Basis (Detail)
Fair Value Measurements - Summary Of Cash And Cash Equivalents (Detail)
Financial Instruments And Risk
Financial Instruments And Risk - Additional Information (Detail)
Government Grant
Government Grant - Additional Information (Details)
Income Tax
Income Tax (Tables)
Income Tax - Additional Information (Detail)
Income Tax - Reconciliation Of Income Tax Attributable To Operations (Detail)
Income Tax - Reconciliation Of Income Tax Attributable To Operations (Parenthetical) (Detail)
Income Tax - Reconciliation Of Unrecognized Tax Benefits Of Uncertain Tax Positions (Detail)
Income Tax - Summary Of Tax Effects Of Temporary Differences And Carryforwards Rise To Deferred Tax Assets And Liabilities (Detail)
Income Tax - Summary Of U.S. And Foreign Components Of Income (Loss) Before Income Taxes (Detail)
Income Tax - Summary Of Years Open To Examination Under Different Jurisdiction (Detail)
Intangibles
Intangibles (Tables)
Intangibles - Additional Information (Detail)
Intangibles - Components Of Intangible Assets (Detail)
Intangibles - Estimated Future Amortization Expense Related To Intangible Assets (Detail)
License Agreements
License Agreements - Additional Information (Detail)
Nature Of Business, Basis Of Presentation And Liquidity Risk
Nature Of Business, Basis Of Presentation And Liquidity Risk - Additional Information (Detail)
Other Assets
Property And Equipment
Property And Equipment (Tables)
Property And Equipment - Summary Of Property And Equipment (Detail)
Quarterly Financial Information (Unaudited)
Quarterly Financial Information (Unaudited) (Tables)
Quarterly Financial Information (Unaudited) - Quarterly Financial Information (Detail)

Material Contracts, Statements, Certifications & more

Achieve Life Sciences, Inc. provided additional information to their SEC Filing as exhibits

Ticker: ACHV
CIK: 949858
Form Type: 10-K Annual Report
Accession Number: 0001564590-22-009485
Submitted to the SEC: Thu Mar 10 2022 8:19:10 AM EST
Accepted by the SEC: Thu Mar 10 2022
Period: Friday, December 31, 2021
Industry: In Vitro And In Vivo Diagnostic Substances

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