SEATTLE and VANCOUVER, BC, Nov. 12,
2020 /CNW/ -- 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 third quarter
2020 financial results and provided an update on the cytisinicline
clinical development program.
Recent Events & Highlights
- Initiated the Phase 3 ORCA-2 clinical trial evaluating the
efficacy and safety of 3 mg cytisinicline dosed 3 times daily
compared to placebo in 750 adult smokers at 15 clinical sites in
the United States
- Promoted John Bencich to Chief
Executive Officer and Dr. Cindy
Jacobs to President
- Presented successful results from the RAUORA, head-to-head
non-inferiority clinical trial comparing cytisinicline and Chantix®
(varenicline), at the Society for Research on Nicotine and Tobacco
European (SRNT-E) Annual Meeting
- Presented mechanism of action data comparing 5-HT3
receptor activity of cytisinicline vs. Chantix at SRNT-E, providing
rationale for differentiated side effect profile of smoking
cessation treatments
- Announced smoking cessation Key Opinion Leader Virtual
Roundtable to be held on November 17,
2020
"With the initiation of the Phase 3 ORCA-2 trial and the
breakthrough evidence, both mechanistically and clinically, in
support of cytisinicline in comparison to Chantix, the third
quarter of 2020 has undeniably been the most pivotal in the history
of our company," commented John
Bencich, Chief Executive Officer of Achieve. "Our primary
focus in the coming months will be enrollment and execution of
ORCA-2, while continuing to explore opportunities for
commercialization and expansion into new therapeutic indications,
digital health technologies, and audiences who may benefit from
cytisinicline, specifically, users of vapes or e-cigarettes."
Phase 3 ORCA-2 Trial Initiation
Achieve's first Phase
3 ORCA-2 trial was initiated in October
2020 and will randomize 750 U.S. smokers to one of three
study arms to determine the efficacy and safety of cytisinicline
administered for either 6 or 12 weeks, compared to placebo. The
primary endpoint is biochemically verified continuous abstinence
during the last 4 weeks of treatment in the 6 and 12-week
cytisinicline treatment arms compared to placebo. Each
treatment arm will be compared independently to the placebo arm and
the trial will be determined to be successful if either or both of
the cytisinicline treatment arms show a statistical benefit
compared to placebo.
Management Team Update
In September, the Company
announced the promotion of John
Bencich to Chief Executive Officer and Dr. Cindy Jacobs to President. Mr. Bencich has been
serving as Achieve's Chief Financial and Operating Officer since
2017 and will join the Board of Directors in his role. Dr. Jacobs
has been serving as the Chief Medical Officer of Achieve since 2017
and will continue in her role leading the regulatory and clinical
development efforts for cytisinicline. Rick
Stewart will remain with Achieve as the Executive Chairman
of the Board of Directors and Dr. Anthony
Clark will remain in his role as Chief Scientific
Officer.
RAUORA: Significantly Fewer Adverse Events and Higher Quits
Rates for Cytisinicline vs Chantix
Final results from
the New Zealand RAUORA Phase 3 non-inferiority clinical trial
comparing cytisinicline to varenicline (Chantix) in Māori
(indigenous New Zealanders) and whānau (family) of Māori were
presented at the SRNT-E Annual Meeting in September 2020. Results showed that cytisinicline
met the pre-specified non-inferiority endpoint and was trending
towards superiority demonstrating a 4.29% improvement in quit rates
in favor of cytisinicline. Subjects in the cytisinicline arm were
approximately one and a half times more likely to have quit smoking
at 6 months compared to subjects who received varenicline.
Importantly, significantly fewer overall adverse events (AEs) were
reported in cytisinicline-treated subjects. Of the subjects who
experienced AEs (111 in the cytisinicline arm compared to 138 in
the varenicline arm), there was significantly less nausea and vivid
dreams.
MOA Data Explaining Reduced Nausea and Vomiting with
Cytisinicline Presented at SRNT-E
Data presented at the
SRNT-E Annual Meeting in September
2020 provides a rationale based on detailed receptor
pharmacology to explain why the incidence of nausea and vomiting
associated with cytisinicline appears to be consistently lower than
that seen with Chantix. The preclinical study, conducted at the
University of Cambridge Department of
Biochemistry, was designed to examine the in vitro binding
characteristics of cytisinicline compared to varenicline at the
human 5-HT3 receptor. The study reported an IC50 of 0.50
mM for cytisinicline and 0.25 µM for varenicline, representing a
2000-greater fold agonist binding affinity to the 5-HT3
receptor for varenicline compared to cytisinicline.
Virtual Smoking Cessation KOL Roundtable to be Held
November 17, 2020
Achieve
announced plans to host a virtual roundtable on cytisinicline and
smoking cessation on Tuesday, November 17,
2020, at 12:00PM EST. Five
esteemed experts in the field of smoking cessation will discuss the
ongoing ORCA-2 trial, review recent cytisinicline data, and discuss
the importance of smoking cessation in the midst of the COVID-19
pandemic. Visit
http://ir.achievelifesciences.com/events-and-webcasts for
additional information and click here to register for the
event.
Financial Results
As of September 30, 2020, the company's cash, cash
equivalents, and restricted cash was $22.4
million. Total operating expenses for the three and nine
months ended September 30, 2020 were
$3.8 million and $10.0 million, respectively. Total net loss for
the three and nine months ended September
30, 2020 was $3.8 million and
$10.0 million, respectively.
As of November 12, 2020, Achieve
had 3,617,664 shares outstanding.
Conference Call Details
Achieve will host a
conference call at 4:30pm Eastern
time today, Thursday, November 12,
2020. To access the webcast, log on to the investor
relations page of the Achieve website at
http://ir.achievelifesciences.com/events-and-webcasts.
Alternatively, access to the live conference call is available by
dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791
(International) and referencing conference ID 8047128. A webcast
replay will be available approximately two hours after the call and
will be archived on the website for 90 days.
About Achieve and Cytisinicline
Tobacco use is currently the leading cause of preventable death
that is responsible for more than eight million deaths worldwide
and nearly half a million deaths in the U.S.
annually.1,2 More than 87% of lung cancer deaths,
61% of all pulmonary disease deaths, and 32% of all deaths from
coronary heart disease are attributable to smoking and exposure to
secondhand smoke.2 Achieve's focus is to address
the global smoking health and nicotine addiction epidemic through
the development and commercialization of
cytisinicline.
Cytisinicline is a plant-based alkaloid with a high binding
affinity to the nicotinic acetylcholine receptor. It is believed to
aid in smoking cessation by interacting with nicotine receptors in
the brain by reducing the severity of nicotine withdrawal symptoms
and by reducing the reward and satisfaction associated with
smoking.
Forward Looking Statements
This press release contains
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995,
including, but not limited to, statements regarding the timing and
nature of cytisinicline clinical development and commercialization
activities, the potential market size for cytisinicline, the
potential benefits of cytisinicline, the ability to discover and
develop new uses for cytisinicline, including but not limited to as
an e-cigarette cessation product, and the development and
effectiveness of new treatments. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. Achieve may not actually achieve its
plans or product development goals in a timely manner, if at all,
or otherwise carry out its intentions or meet its expectations or
projections disclosed in these forward-looking statements. These
statements are based on management's current expectations and
beliefs and are subject to a number of risks, uncertainties and
assumptions that could cause actual results to differ materially
from those described in the forward-looking statements, including,
among others, the risk that cytisinicline may not demonstrate the
hypothesized or expected benefits; the risk that Achieve may not be
able to obtain additional financing to fund the development of
cytisinicline; the risk that cytisinicline will not receive
regulatory approval or be successfully commercialized; the risk
that new developments in the smoking cessation landscape require
changes in business strategy or clinical development plans; the
risk that Achieve's intellectual property may not be adequately
protected; general business and economic conditions; risks related
to the impact on our business of the COVID-19 pandemic or similar
public health crises and the other factors described in the
risk factors set forth in Achieve's filings with the Securities and
Exchange Commission from time to time, including Achieve's Annual
Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve
undertakes no obligation to update the forward-looking statements
contained herein or to reflect events or circumstances occurring
after the date hereof, other than as may be required by
applicable.
Media Contact
Glenn Silver
Glenn.Silver@Finnpartners.com
(646) 871-8485
Investor Relations Contact
Jason Wong
jwong@bplifescience.com
(415) 375-3340 ext. 4
References
1 World Health Organization. WHO Report on the
Global Tobacco Epidemic, 2019. Geneva: World Health Organization,
2017.
2 U.S. Department of Health and Human Services. The
Health Consequences of Smoking – 50 Years of Progress. A Report of
the Surgeon General, 2014.
Chantix® is a registered trademark of Pfizer Inc.
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Consolidated
Statements of Loss
|
(In thousands,
except per share and share data)
|
|
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
1,891
|
|
1,824
|
|
4,535
|
|
7,911
|
General and
administrative
|
|
|
1,863
|
|
1,893
|
|
5,494
|
|
5,408
|
Total operating expenses
|
|
|
3,754
|
|
3,717
|
|
10,029
|
|
13,319
|
Loss from
operations
|
|
|
(3,754)
|
|
(3,717)
|
|
(10,029)
|
|
(13,319)
|
Other income
(expense)
|
|
|
(10)
|
|
44
|
|
23
|
|
118
|
Net loss
|
|
|
$
(3,764)
|
|
$
(3,673)
|
|
$
(10,006)
|
|
$
(13,201)
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|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
$
(1.14)
|
|
$
(9.07)
|
|
$
(4.55)
|
|
$
(35.96)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares
|
|
|
3,289,252
|
|
405,012
|
|
2,197,368
|
|
367,103
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Consolidated
Balance Sheets
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
|
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|
|
2020
|
|
2019
|
|
|
|
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|
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Assets:
|
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|
|
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|
Cash, cash
equivalents, short term investments and restricted cash
|
|
|
|
|
|
|
$
22,443
|
|
$
16,714
|
Prepaid
expenses and other current assets
|
|
|
|
|
|
|
1,669
|
|
670
|
Property,
equipment and other assets
|
|
|
|
|
|
|
358
|
|
244
|
Right-of-use
assets
|
|
|
|
|
|
|
193
|
|
329
|
License
agreement
|
|
|
|
|
|
|
1,920
|
|
2,087
|
Goodwill
|
|
|
|
|
|
|
1,034
|
|
1,034
|
Total
assets
|
|
|
|
|
|
|
$
27,617
|
|
$
21,078
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
|
|
|
|
|
$
1,719
|
|
$
2,666
|
Current
portion of long-term obligations
|
|
|
|
|
|
|
129
|
|
203
|
Long-term
obligations
|
|
|
|
|
|
|
94
|
|
159
|
Stockholders'
equity
|
|
|
|
|
|
|
25,675
|
|
18,050
|
Total liabilities and
stockholders' equity
|
|
|
|
|
|
|
$
27,617
|
|
$
21,078
|
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SOURCE Achieve Life Sciences, Inc.