Achieve Life Sciences, Inc. (ACHV) 10K Annual Reports & 10Q SEC Filings

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

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

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

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

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

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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 - Expense Highlight
Research and Development Costs Research and development costs are expensed as incurred, net of related refundable investment tax credits, with the exception of non-refundable advance payments for goods or services to be used in future research and development, which are capitalized in accordance with ASC 730, "Research and Development" and included within Prepaid Expenses or Other Assets depending on when the assets will be utilized.

Revenue - Product Highlight
At-the-Market Sales Agreement On December 21, 2022, we entered into an At-the-Market Offering Sales Agreement, or ATM, with Virtu Americas, LLC, as sales agent, pursuant to which we may sell shares of common stock with an aggregate offering price of up to $25 million.
Other - Other Highlight
As of December 31, 2021, we had a cash and cash equivalents balance of $43.0 million and a positive working capital balance of $40.0 million.
Other - Other Highlight
As of December 31, 2021, we had an accumulated deficit of $93.6 million, cash and cash equivalents balance of $43.0 million and a positive working capital balance of $40.0 million.
Revenue - Product Highlight
While we believe that we will be able to settle our commitments and liabilities in the normal course of business as they fall due during the next 12 months, as a development-stage company with no current sources of revenue, our ability to support our working capital and capital expenditure requirements in the long term will depend on many factors, including our ability to raise funds (through public or private securities offerings, debt financings, government funding or grants, or other sources, which may include licensing, collaborations or other strategic transactions or arrangements) to support the ongoing advancement of our clinical trials and corporate activities.
Financial - Shares
On July 29, 2020, we...Read more
Financial - Income
Additionally, if we successfully commercialize...Read more
Financial - Income
Additionally, if we successfully commercialize...Read more
Financial - Expense
We expect our R&D expenses...Read more
Financial - Expense
This was partially offset by...Read more
Other - Other
Intangible Assets Our intangible assets...Read more
Financial - Expense
The underwritten public offering raised...Read more
Financial - Expense
The underwritten public offering raised...Read more
Financial - Expense
The underwritten public offering raised...Read more
Other - Other
All cytisinicline treatment arms showed...Read more
Financial - Expense
The registered direct offering raised...Read more
Revenue - Geography
At the SRNT European meeting...Read more
Other - Other
We adopted the standard on...Read more
Other - Other
We elected to early adopt...Read more
Other - Other
Topline results indicated that the...Read more
Financial - Expense
Compensation expense is recorded over...Read more
Financial - Expense
The underwriting discounts and commissions...Read more
Financial - Expense
The underwriting discounts and commissions...Read more
Financial - Expense
The underwriting discounts and commissions...Read more
Financial - Debt
Additionally, all outstanding Convertible Debt,...Read more
Financial - Expense
In the event payments differ...Read more
Financial - Shares
A holder of Pre-Funded Warrants...Read more
Other - Other
We may in the future...Read more
Other - Other
All subsequent written or oral...Read more
Revenue - Product
These aggregate sales resulted in...Read more
Financial - Shares
May 2021 Public Offering On...Read more
M & A - Other
The reverse stock split was...Read more
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The placement agent for the...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

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

Exhibit 21.1: Subsidaries Of The Registrant

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

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