UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K/A
☒ |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2022
Or
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 033-80623
Achieve Life Sciences, Inc.
(Exact name of the registrant as specified in its charter)
Delaware |
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95-4343413 |
(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
22722 29th Drive SE, Suite 100, Bothell, WA 98021
1040 West Georgia Street, Suite 1030, Vancouver, . V6E 4H1
(Address of principal executive offices, including zip code)
(604) 210-2217
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
Trading Symbol(s) |
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Name of Exchange on Which Registered |
Common Stock, par value $0.001 per share |
ACHV |
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The Nasdaq Capital Market LLC |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.). Yes ☐ No ☒
As of June 30, 2022, the aggregate market value of the registrant’s Common Stock held by non-affiliates of the registrant was $47,146,099 computed with reference to the price at which the Common Stock was last sold on June 30, 2022. As of March 16, 2023, 17,930,362 shares of the registrant’s Common Stock were outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Registrant’s Definitive Proxy Statement for its 2023 Annual Meeting of Stockholders (“Proxy Statement”), to be filed within 120 days of the Registrant’s fiscal year ended December 31, 2022, is incorporated by reference into Part III of this Annual Report on Form 10-K.
Auditor Name: PricewaterhouseCooopers LLP Auditor Location: Vancouver, BC, Canada Auditor Firm ID: 271.
2
EXPLANATORY NOTE
This Amendment No. 1 on Form 10-K/A (“Amendment No. 1”) is being filed to amend our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (“the “Original Filing”), filed with the U.S. Securities and Exchange Commission on March 16, 2023 (the “Original Filing Date”). The sole purpose of this Amendment No. 1 is to correct a typographical error in the previously filed Consent of Independent Registered Public Accounting Firm (filed as Exhibit 23.1), which inadvertently referenced the incorrect date with respect to the Report of Independent Registered Public Accounting Firm.
Except as described above, no changes have been made to the Original Filing and this Amendment No. 1 does not modify, amend or update in any way any of the financial or other information contained in the Original Filing. This Amendment No. 1 does not reflect events that may have occurred subsequent to the Original Filing Date.
Pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended, this Amendment No. 1 also contains a new certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002, which is attached hereto. Because no financial statements have been included in this Amendment No. 1 and this Amendment No. 1 does not contain or amend any disclosure with respect to Items 307 and 308 of Regulation S-K, paragraphs 3, 4, and 5 of the certifications have been omitted.
3
Achieve Life Sciences, Inc.
Table of Contents
ITEM 15. |
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5 |
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14 |
4
ITEM 15.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(1) Exhibits Exhibit Exhibits
Exhibit |
Description |
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Incorporated by Reference |
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Filed/ |
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Form |
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File No. |
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Exhibit |
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Filing Date |
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3.1 |
Second Amended and Restated Certificate of Incorporation filed on May 24, 2013 |
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8-K |
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033-80623 |
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3.1 |
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May 29, 2013 |
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3.2 |
Certificate of Amendment to Amended and Restated Certificate of Incorporation filed on May 21, 2015 |
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8-K |
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033-80623 |
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3.1 |
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May 22, 2015 |
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3.3 |
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8-K |
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033-80623 |
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3.1 |
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August 2, 2017 |
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3.4 |
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8-K |
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033-80623 |
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3.2 |
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August 2, 2017 |
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3.5 |
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8-K |
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033-80623 |
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3.1 |
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November 1, 2017 |
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3.6 |
Certificate of Amendment (Reverse Stock Split) to the Second Amended and |
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8-K |
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033-80623 |
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3.1 |
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May 23, 2018 |
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3.7 |
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8-K |
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033-80623 |
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3.2 |
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May 23, 2018 |
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3.8 |
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8-K |
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033-80623 |
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3.1 |
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December 20, 2019 |
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3.9 |
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8-K |
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033-80623 |
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3.1 |
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January 5, 2017 |
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3.10 |
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10-Q |
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033-80623 |
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3.1 |
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November 7, 2018 |
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4.1 |
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10-Q |
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000-21243 |
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4.1 |
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November 10, 2008 |
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4.2 |
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8-K |
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033-80623 |
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4.1 |
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September 14, 2017 |
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4.3 |
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8-K |
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033-80623 |
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4.1 |
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June 20, 2018 |
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4.4 |
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8-K |
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033-80623 |
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4.2 |
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June 20, 2018 |
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4.5 |
Form of Common Stock Purchase Warrant (October 2018 Private Placement) |
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8-K |
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033-80623 |
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4.1 |
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October 1, 2018 |
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4.6 |
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8-K |
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033-80623 |
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4.1 |
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June 3, 2019 |
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4.7 |
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8-K |
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033-80623 |
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4.1 |
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December 20, 2019 |
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4.8 |
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8-K |
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033-80623 |
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4.1 |
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April 30, 2020 |
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4.9 |
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8-K |
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033-80623 |
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4.1 |
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August 4, 2020 |
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4.10 |
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S-1 |
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333-250074 |
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4.11 |
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November 30, 2020 |
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4.11 |
Description of Securities Registered Under Section 12 of the Securities Exchange Act of 1934 |
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10-K |
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033-80623 |
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4.12 |
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March 13, 2020 |
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4.12 |
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8-K |
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033-80623 |
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10.1 |
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December 22, 2021 |
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4.13 |
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8-K |
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033-80623 |
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4.1 |
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November 18, 2022 |
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4.14 |
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8-K |
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033-80623 |
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10.2 |
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November 18, 2022 |
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10.1 |
Form of OncoGenex Pharmaceuticals, Inc. 2010 Stock Option Agreement |
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8-K |
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033-80623 |
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10.1 |
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June 14, 2010 |
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10.2 |
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10-Q |
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033-80623 |
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10.2 |
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November 3, 2011 |
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10.3 |
OncoGenex Pharmaceuticals, Inc. 2010 Performance Incentive Plan, as amended and restated |
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DEF 14A |
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033-80623 |
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Appendix A |
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April 16, 2015 |
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10.4 |
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DEF 14A |
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033-80623 |
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Appendix A |
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September 21, 2017 |
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10.5 |
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10-Q |
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033-80623 |
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10.7b |
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March 1, 2018 |
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10.6 |
Form of Achieve Life Sciences Restricted Stock Unit Agreement |
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10-Q |
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033-80623 |
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10.7c |
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March 1, 2018 |
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10.7 |
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DEF 14A |
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033-80623 |
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Appendix B |
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September 21, 2017 |
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10.8 |
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10-K |
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033-80623 |
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10.8 |
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March 16, 2023 |
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10.9 |
Form of Indemnification Agreement for Officers and Directors of the Company (p) |
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S-1 |
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33-96112 |
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10.19 |
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September 25, 1995 |
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10.10 |
Form of Indemnification Agreement between OncoGenex Technologies Inc. and Cindy Jacobs |
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F-1 |
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333-139293 |
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10.7 |
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December 13, 2006 |
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10.11 |
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10-Q |
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033-80623 |
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10.27 |
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November 5, 2009 |
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10.12 |
Employment Agreement between OncoGenex Pharmaceuticals, Inc. and John Bencich |
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10-Q |
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033-80623 |
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10.1 |
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November 10, 2016 |
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10.13 |
Employment Agreement between the Company and Richard Stewart, executed May 22, 2018 |
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8-K |
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033-80623 |
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10.1 |
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May 23, 2018 |
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10.14 |
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S-4/A |
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333-216961 |
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10.21 |
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May 3, 2017 |
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10.15 |
Variation of Contract, by and between Sopharma AD and Extab Corporation, dated May 14, 2015* |
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S-4/A |
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333-216961 |
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10.22 |
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May 3, 2017 |
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10.16 |
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S-4/A |
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333-216961 |
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10.23 |
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May 3, 2017 |
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10.17 |
Variation of Contract, by and between Sopharma AD and Extab Corporation, dated May 14, 2015* |
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S-4/A |
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333-216961 |
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10.24 |
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May 3, 2017 |
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10.18 |
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S-4/A |
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333-216961 |
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10.25 |
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May 3, 2017 |
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10.19 |
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S-4/A |
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333-216961 |
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10.27 |
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May 3, 2017 |
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10.20 |
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10-Q/A |
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033-80623 |
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10.1 |
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May 23, 2018 |
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10.21 |
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10-K |
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033-80623 |
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10.25 |
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March, 14, 2019 |
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10.22 |
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10-K |
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033-80623 |
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10.22 |
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March 16, 2023 |
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10.23 |
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10-Q |
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033-80623 |
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10.1 |
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November 9, 2017 |
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10.24 |
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10-Q |
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033-80623 |
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10.1 |
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November 12, 2020 |
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10.25 |
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10-Q |
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033-80623 |
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10.3 |
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November 12, 2020 |
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September 28, 2020, by and between Achieve Life Sciences, Inc. and John Bencich |
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10.26 |
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10-K |
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003-80623 |
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10.26 |
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March 16, 2023 |
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10.27 |
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S-3 |
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333-261811 |
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1.2 |
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December 21, 2021 |
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10.28 |
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8-K |
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033-80623 |
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10.1 |
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December 22, 2021 |
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10.29 |
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8-K |
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033-80623 |
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10.2 |
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April 27, 2022 |
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10.30 |
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8-K |
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033-80623 |
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10.1 |
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April 27, 2022 |
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21.1 |
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10-K |
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033-80623 |
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21.1 |
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March 16, 2023 |
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23.1 |
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24.1 |
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10-K |
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033-80623 |
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24.1 |
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March 16, 2023 |
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31.1 |
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32.1 |
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10-K |
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033-80623 |
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32.1 |
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March 16, 2023 |
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101.INS |
Inline XBRL Instance Document |
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10-K |
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033-80623 |
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101.INS |
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March 16, 2023 |
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101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
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10-K |
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033-80623 |
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101.SCH |
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March 16, 2023 |
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101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
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10-K |
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033-80623 |
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101.CAL |
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March 16, 2023 |
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101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
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10-K |
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033-80623 |
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101.DEF |
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March 16, 2023 |
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101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
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10-K |
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033-80623 |
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101.LAB |
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March 16, 2023 |
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101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
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10-K |
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033-80623 |
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101.PRE |
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March 16, 2023 |
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104 |
Cover Page Interactive Data File (embedded |
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10-K |
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033-80623 |
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104 |
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March 16, 2023 |
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12
13
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.
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ACHIEVE LIFE SCIENCES, INC. |
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(Registrant) |
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Date: May 16, 2023 |
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By: |
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/s/ JOHN BENCICH |
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John Bencich |
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Chief Executive Officer |
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Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
By: /s/ JOHN BENCICH |
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Chief Executive Officer and Director (Principal Executive Officer and Financial Officer) |
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Date: May 16, 2023 |
John Bencich |
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By: /s/ JERRY WAN |
Senior Director of Accounting Operations (Principal Accounting Officer) |
Date: May 16, 2023 |
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Jerry Wan |
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By: * |
Executive Chairman and Director |
Date: May 16, 2023 |
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Richard Stewart |
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By: * |
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President, Chief Medical Officer and Director |
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Date: May 16, 2023 |
Cindy Jacobs |
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By: |
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Director |
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Date: May 16, 2023 |
Stuart Duty |
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By: * |
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Director |
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Date: May 16, 2023 |
Donald Joseph |
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By: |
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Director |
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Date: May 16, 2023 |
Thomas King |
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By: * |
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Director |
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Date: May 16, 2023 |
Martin Mattingly |
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By: * |
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Director |
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Date: May 16, 2023 |
Bridget Martell |
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By: * |
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Director |
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Date: May 16, 2023 |
Jay Moyes |
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By: * |
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Director |
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Date: May 16, 2023 |
Vaughn Himes |
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By: |
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Director |
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Date: May 16, 2023 |
Thomas Sellig |
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*By: /S/ JOHN BENCICH |
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John Bencich |
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Attorney-in-Fact |
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15
Exhibit 23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the registration statements on Form S-8 (File Nos.333-153206, 333-168820, 333-190480, 333-197937, 333-206569, 333-221473, 333-228253, 333-231520, 333-236059, 333-238505, 333-254156 and 333-263421), Form S-1 (File Nos. 333-228596, 333-232817, 333-234530, 333-238970 and 333-250074) and Form S-3 (File Nos. 333-269059and 333-261811) of Achieve Life Sciences, Inc. of our report dated March 16, 2023 relating to the consolidated financial statements, which appears in the Annual Report on Form 10-K for the year ended December 31, 2022.
/s/ PricewaterhouseCoopers LLP
Chartered Professional Accountants
Vancouver, Canada
May 16, 2023
Exhibit 31.1
Certification Pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
I, John Bencich, certify that:
1. I have reviewed this annual report on Form 10-K of Achieve Life Sciences, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report.
Date: May 16, 2023
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/s/ JOHN BENCICH |
John Bencich |
Chief Executive Officer (Principal Executive and Financial Officer) |