SEATTLE and VANCOUVER, British Columbia, May 15, 2019 /CNW/ -- Achieve Life Sciences,
Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company
committed to the global development and commercialization of
cytisinicline for smoking cessation, today provided an update on
the cytisinicline clinical development program and announced first
quarter 2019 financial results.
ORCA-1 Trial Status
Achieve's 254-subject Phase
2b ORCA-1 trial of cytisinicline in
U.S. smokers completed enrollment in February. The Company
announced recently that the last study visit for the last subject
enrolled in the ORCA-1 trial has occurred. The trial is evaluating
cytisinicline in both the 1.5 mg and 3.0 mg doses on a declining
titration schedule as well as three times daily dosing, both over
25 days. The primary efficacy endpoint is reduction in the number
of cigarettes smoked during treatment with secondary analyses to be
conducted on smoking cessation rates, safety, and compliance.
ORCA-1 topline efficacy and safety data are expected to be
announced by the end of the second quarter.
Maximum Tolerated Dose (MTD) Trial Extension
Achieve
recently initiated a trial to assess the MTD for a single
administered oral dose of cytisinicline in smokers. The starting
dosage of cytisinicline was 6 mg and is increased in separate
groups of subjects for each escalated dose level until stopping
criteria, based on the occurrence of dose-limiting adverse events,
are reached. To date, 21 mg cytisinicline has been evaluated
without evidence of dose limiting toxicity. The trial's Data Safety
Monitoring Committee has recommended a protocol amendment to
evaluate additional higher doses of cytisinicline.
Rick Stewart, Chairman and Chief
Executive Officer of Achieve Life Sciences commented, "With the
results of the ORCA-1 trial expected by the end of the second
quarter, we are rapidly approaching another critical milestone for
the cytisinicline development program. Importantly, as confirmed by
the tolerability of high dose levels in our MTD study, we believe
cytisinicline may offer a differentiated and new treatment option
for the millions of people who are battling nicotine
addiction."
Financial Results
As of March
31, 2019, the company's cash, cash equivalents, short-term
investments and restricted cash were $9.7
million. Each of total operating expenses and net loss for
the first quarter of 2019 were $5.9
million.
As of May 15, 2019 Achieve had
6,865,950 shares outstanding.
Conference Call Details
Achieve will host a conference
call at 4:30 p.m. Eastern time today,
Wednesday, May 15, 2019. 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 6973659. 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 and is responsible
for nearly seven million deaths annually worldwide1. It
is estimated that 28.7% of cancer deaths in the U.S. are
attributable to cigarette smoking2. Achieve's focus is
to address the global smoking health 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.
As an approved, branded product in Central and Eastern Europe for more than two decades, it
is estimated that over 20 million people have used cytisinicline to
help combat nicotine addiction.
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 planned
cytisinicline clinical development activities, the timing of
clinical development activities related to cytisinicline,
expectations from current data, expectations regarding when trial
data may be reported, the potential market size for
cytisinicline and the potential benefits of cytisinicline. 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; 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.
Achieve Contact
Jason
Wong
jwong@bplifescience.com
(415) 375-3340 ext. 4
"ORCA is a trademark of Achieve Life Sciences, Inc."
1 World Health Organization. WHO Report on the
Global Tobacco Epidemic, 2017. Geneva: World Health Organization, 2017
2 Annals of Epidemiology , Volume 25 , Issue 3 ,
179 - 182.e1
Consolidated
Statements of Loss
|
(In thousands,
except per share and share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
|
|
4,055
|
|
1,201
|
General and
administrative
|
|
|
|
1,885
|
|
1,813
|
Total operating expenses
|
|
|
|
5,940
|
|
3,014
|
Loss from
operations
|
|
|
|
(5,940)
|
|
(3,014)
|
Other income
(expense)
|
|
|
|
36
|
|
(8)
|
Net loss
|
|
|
|
$
(5,904)
|
|
$
(3,022)
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
|
$
(0.88)
|
|
$
(2.43)
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares
|
|
|
|
6,721,184
|
|
1,243,149
|
Consolidated
Balance Sheets
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December
31,
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
Cash, cash
equivalents, short term investments and restricted cash
|
|
|
|
$
9,715
|
|
$
14,654
|
Prepaid
expenses and other current assets
|
|
|
|
866
|
|
933
|
Property,
equipment and other assets
|
|
|
|
177
|
|
153
|
Operating
lease right-of-use assets
|
|
|
|
455
|
|
—
|
License
agreement
|
|
|
|
2,254
|
|
2,310
|
Goodwill
|
|
|
|
1,034
|
|
1,034
|
Total
assets
|
|
|
|
$
14,501
|
|
$
19,084
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
|
|
$
3,813
|
|
$
3,259
|
Current
portion of long-term obligations
|
|
|
|
16
|
|
11
|
Current
portion of long-term lease liability
|
|
|
|
170
|
|
—
|
Long-term
obligations
|
|
|
|
24
|
|
12
|
Long-term
lease liability
|
|
|
|
289
|
|
—
|
Stockholders'
equity
|
|
|
|
10,189
|
|
15,802
|
Total liabilities and
stockholders' equity
|
|
|
|
$
14,501
|
|
$
19,084
|
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SOURCE Achieve Life Sciences, Inc.