Item 1.01. Entry into a Material Definitive Agreement
On
Subject to the terms and conditions of the Loan Agreement, Achieve may borrow
term loans under the Loan Agreement until
Upon and after borrowing under the Loan Agreement, Achieve must comply with
certain financial covenants as set forth in the Loan Agreement and the
Amendment, including a minimum liquidity ratio of at least 1.25 to 1.00, or at
Achieve's election after receiving at least
The foregoing descriptions of the Loan Agreement and the Amendment do not purport to be complete and are subject to, and qualified in their entirety by, such documents attached as Exhibits 10.1 and 10.2, respectively, to this Current Report on Form 8-K, which are incorporated herein by reference.
Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.
The information set forth in Item 1.01 above is incorporated by reference into this Item 2.03.
Item 8.01. Other Events.
On
The primary endpoints for ORCA-2 were biochemically verified continuous abstinence measured during the last 4 weeks of treatment. Both the 6- and 12-week cytisinicline treatments demonstrated significantly better quit rates than placebo with odds ratios of 8.0 and 6.3, respectively.
Subjects who received 12 weeks of cytisinicline treatment had 6.3 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 9-12 was 32.6% for cytisinicline compared to 7.0% for placebo.
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Subjects who received 6 weeks of cytisinicline treatment had 8 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 3-6 was 25.3% for cytisinicline compared to 4.4% for placebo.
Cytisinicline was well tolerated with no treatment-related serious adverse events reported.
A copy of the press release is attached as Exhibit 99.1 to this Current Report
on Form 8-K and is incorporated herein by reference. A copy of Achieve's
corporate presentation featuring data from ORCA-2 to be presented at a
conference call hosted by Achieve on
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibit is filed herewith:
Exhibit No. Description 10.1 Loan and Security Agreement, datedApril 26, 2022 , amongAchieve Life Sciences, Inc. andSilicon Valley Bank 10.2 First Amendment to 2021 Contingent Convertible Debt Agreement datedDecember 22, 2021 by and amongAchieve Life Sciences, Inc. ,Silicon Valley Bank , andSVB Innovation Credit Fund VIII, L.P. 99.1 Press release ofAchieve Life Sciences, Inc. datedApril 27, 2022 99.2Achieve Life Sciences, Inc. Corporate Presentation 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) ________________________
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