Amended Annual Report (10-k/a)
16 Mai 2023 - 10:07PM
Edgar (US Regulatory)
--12-31FY0000949858trueBC00009498582022-01-012022-12-3100009498582022-06-3000009498582023-03-160000949858dei:OtherAddressMember2022-01-012022-12-31xbrli:sharesiso4217:USD
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
10-K/A
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☒
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934
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For the fiscal year ended
December 31,
2022
Or
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Commission File Number
033-80623
Achieve Life Sciences, Inc.
(Exact name of the registrant as specified in its
charter)
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Delaware
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95-4343413
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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22722 29th Drive SE,
Suite 100,
Bothell,
WA
98021
1040 West Georgia Street,
Suite 1030,
Vancouver,
B.C.
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:
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Title of Each Class
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Trading Symbol(s)
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Name of Exchange on Which Registered
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Common Stock, par value $0.001 per share
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ACHV
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The
Nasdaq Capital
Market LLC
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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.
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Large accelerated filer
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Accelerated filer
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Non-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
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No
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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
4
ITEM 15.
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(1) Exhibits Exhibit Exhibits
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Exhibit
Number
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Description
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Incorporated by Reference
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Filed/
Furnished
Herewith
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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
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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
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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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Certificate of Amendment (Reverse Stock Split) to Second Amended
and Restated Certificate of Incorporation filed on August 1,
2017
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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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Certificate of Amendment (Name Change) to Second Amended and
Restated Certificate of Incorporation filed on August 1,
2017
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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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Certificate of Amendment (Elimination of Cumulative Voting) to
Second Amended and Restated Certificate of Incorporation filed on
October 31, 2017
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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
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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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5
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Restated Certificate of Incorporation filed on May 22, 2018
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3.7
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Certificate of Amendment (Increase in Authorized Shares) to the
Second Amended and Restated Certificate of Incorporation filed on
May 22, 2018
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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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Certificate of Designation of Preferences, Rights and Limitations,
with respect to the Series B Convertible Preferred Stock,
filed
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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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Sixth Amended and Restated Bylaws
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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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Amendment to Sixth Amended and Restated Bylaws
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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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Specimen Certificate of Common Stock
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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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Form of Warrant (LPC)
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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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Form of Common Stock Purchase Warrant (June 2018
Offering)
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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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Form of Preferred Stock Certificate
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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
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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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Form of Warrant (May 2019)
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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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Form of Common Stock Purchase
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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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6
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Warrant (December 2019 Offering)
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4.8
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Form of Common Stock Purchase Warrant (April 2020)
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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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Form of Pre-Funded Warrant (August 2020)
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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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Form of Underwriter’s Warrant
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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
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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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Registration Rights Agreement, dated December 22, 2021, among
Achieve Life Sciences, Inc., Silicon Valley Bank and SVB Innovation
Credit Fund VIII, L.P.
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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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Form of Common Stock Purchase Warrant (November
2022)
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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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Form of Registration Rights Agreement (November
2022)
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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
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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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Form of OncoGenex Pharmaceuticals, Inc. 2010
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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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7
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Restricted Stock Unit Agreement††
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10.3
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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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Achieve Life Sciences 2017 Equity Incentive Plan††
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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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Form of Achieve Life Sciences Stock Option
Agreement††
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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
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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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Achieve Life Sciences 2017 Employee Stock Purchase
Plan††
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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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Achieve Life Sciences 2018 Equity Incentive Plan, as amended, and
forms of award agreements thereunder††
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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
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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
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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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Employment Agreement between the Company and
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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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8
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Cindy Jacobs dated as of November 3, 2009††
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10.12
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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
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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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Exclusive License Agreement, by and between Sopharma Joint Stock
Company and Extab Corporation, dated May 26, 2009*
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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
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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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Commercial Agreement on Supply of Pharmaceutical Products, by and
between Sopharma AD and Extab Corporation, dated February 1,
2010*
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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
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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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Technical and Quality Agreement, 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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10.25
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May 3, 2017
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9
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10.19
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License of Technology, by and between University of Bristol and
Achieve Life Science, Inc., dated July 13, 2016*
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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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Amendment to University of Bristol License Agreement, dated January
22, 2018, by and between Achieve Life Science, Inc., and the
University of Bristol*
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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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Office Lease by and between 0846869 B.C. Ltd. and Achieve Life
Sciences Technologies Inc., commencing February 1,
2019
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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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Amendment to Office Lease, dated December 16, 2022, by and between
0846869 B.C. Ltd. and Achieve Life Sciences Technologies
Inc.
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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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Amended and Restated Supply Agreement, dated July 28, 2017, by and
between Achieve Life Science, Inc., and Sopharma AD*
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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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Letter of Variation, dated September 28, 2020, by and between
Achieve Pharma UK Limited and Richard Stewart††
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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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Amended and Restated Employment Agreement, dated
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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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10
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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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Amended and Restated Employment Agreement, dated September 27,
2022, by and between Achieve Life Sciences, Inc. and Cindy Jacobs
††
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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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At the Market Sales Agreement, dated December 21, 2021, by and
between Achieve Life Sciences, Inc. and Virtu Americas
LLC
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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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Contingent Convertible Debt Agreement, dated December 22, 2021,
among Achieve Life Sciences, Inc., Silicon Valley Bank and SVB
Innovation Credit Fund VIII, L.P.
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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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First Amendment to 2021 Contingent Convertible Debt Agreement dated
December 22, 2021 by and among Achieve Life Sciences, Inc., Silicon
Valley Bank, and SVB Innovation Credit Fund VIII,
L.P.
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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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Loan and Security Agreement, dated April 26, 2022, among Achieve
Life Sciences, Inc. and Silicon Valley Bank
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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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Subsidiaries of the Registrant
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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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11
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23.1
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Consent of PricewaterhouseCoopers LLP
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X
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24.1
|
Power of Attorney
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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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Certification of Chief Executive Officer (Principal Executive
Officer and Financial Officer) pursuant to Rule 13a-14(a) or
15d-14(a) of the Securities Exchange Act of 1934, as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
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X
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32.1
|
Certification of Chief Executive Officer (Principal Executive
Officer and Financial Officer) pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002**
|
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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
|
|
10-K
|
|
033-80623
|
|
101.INS
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|
March 16, 2023
|
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101.SCH
|
Inline XBRL Taxonomy Extension Schema Document
|
|
10-K
|
|
033-80623
|
|
101.SCH
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|
March 16, 2023
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101.CAL
|
Inline XBRL Taxonomy Extension Calculation Linkbase
Document
|
|
10-K
|
|
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
|
|
10-K
|
|
033-80623
|
|
101.DEF
|
|
March 16, 2023
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101.LAB
|
Inline XBRL Taxonomy Extension Label Linkbase Document
|
|
10-K
|
|
033-80623
|
|
101.LAB
|
|
March 16, 2023
|
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101.PRE
|
Inline XBRL Taxonomy Extension Presentation Linkbase
Document
|
|
10-K
|
|
033-80623
|
|
101.PRE
|
|
March 16, 2023
|
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104
|
Cover Page Interactive Data File (embedded
|
|
10-K
|
|
033-80623
|
|
104
|
|
March 16, 2023
|
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12
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within the Inline XBRL document)
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†
|
Schedules and similar attachments to the Merger Agreement have been
omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company
will furnish supplementally a copy of any omitted schedule or
similar attachment to the SEC upon request.
|
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|
††
|
Indicates management contract or compensatory plan or
arrangement.
|
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|
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*
|
The Company has omitted portions of the exhibit as permitted under
Item 601(b)(10) of Regulation S-K.
|
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|
**
|
The certifications attached as Exhibits 32.1 and 32.2 accompany to
this Annual Report on Form 10-K pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of
2002, and shall not be deemed filed for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended.
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|
|
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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|
|
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|
|
|
ACHIEVE LIFE SCIENCES, INC.
|
|
|
|
|
(Registrant)
|
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|
|
Date: May 16, 2023
|
|
|
|
By:
|
|
/s/ JOHN BENCICH
|
|
|
|
|
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|
John Bencich
|
|
|
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Chief Executive Officer
|
14
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.
|
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|
|
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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
|
|
|
|
|
|
|
|
By: /s/ JERRY WAN
|
Senior Director of Accounting Operations (Principal Accounting
Officer)
|
Date: May 16, 2023
|
Jerry Wan
|
|
|
|
|
|
By: *
|
Executive Chairman and Director
|
Date: May 16, 2023
|
Richard Stewart
|
|
|
|
|
|
By: *
|
|
President, Chief Medical Officer and Director
|
|
Date: May 16, 2023
|
Cindy Jacobs
|
|
|
|
|
|
|
|
By:
|
|
Director
|
|
Date: May 16, 2023
|
Stuart Duty
|
|
|
|
|
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|
|
By: *
|
|
Director
|
|
Date: May 16, 2023
|
Donald Joseph
|
|
|
|
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|
|
By:
|
|
Director
|
|
Date: May 16, 2023
|
Thomas King
|
|
|
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|
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|
|
By: *
|
|
Director
|
|
Date: May 16, 2023
|
Martin Mattingly
|
|
|
|
|
|
|
|
By: *
|
|
Director
|
|
Date: May 16, 2023
|
Bridget Martell
|
|
|
|
|
|
|
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|
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By: *
|
|
Director
|
|
Date: May 16, 2023
|
Jay Moyes
|
|
|
|
|
|
|
|
|
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By: *
|
|
Director
|
|
Date: May 16, 2023
|
Vaughn Himes
|
|
|
|
|
|
|
|
|
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By:
|
|
Director
|
|
Date: May 16, 2023
|
Thomas Sellig
|
|
|
|
|
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|
|
*By: /S/ JOHN BENCICH
|
|
|
|
|
John Bencich
|
|
|
|
|
Attorney-in-Fact
|
|
|
|
|
15
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