SEATTLE and VANCOUVER, British Columbia, Aug. 8, 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 second
quarter 2019 financial results.
Q2 2019 Highlights
- Reported positive results from the Phase 2b ORCA-1 dose-selection trial evaluating
cytisinicline in 254 smokers. Cytisinicline demonstrated a
statistically significant improvement in quit rates for a
simplified 3.0 mg, three times daily dose. Cytisinicline was
well-tolerated with no serious adverse events reported.
- Announced ORCA-1 data has been accepted for an oral
presentation at the Society for Research on Nicotine & Tobacco
Europe (SRNT-E) 19th Annual Conference to be held in Oslo, Sept. 12-14,
2019
- Patent granted in the U.S. for new cytisinicline succinate salt
formulation designed to enhance product stability and long-term
potency
- Received $4.2 million in proceeds
from exercise of warrants
"It has been an exciting quarter with the release of the
positive ORCA-1 Phase 2b trial
results that demonstrated impressive smoking cessation efficacy,
safety, and cytisinicline treatment adherence," commented
Rick Stewart, Chairman and Chief
Executive Officer of Achieve. "The data exceeded our expectations
and provide a clear path forward for our future Phase 3
program."
ORCA-1 Positive Study Results
The Phase 2b ORCA-1 trial of cytisinicline in U.S. smokers
demonstrated a statistically significant improvement in quit rates
for the 3.0 mg, three times daily dosing (TID) schedule. In the 3.0
mg TID arm, a 54% abstinence rate at week 4, compared to 16% for
placebo (p < 0.0001) was observed. Continuous abstinence at
weeks 5 through 8 was 30% for cytisinicline compared to 8% for
placebo (p= 0.005). Adherence to study treatment was 98% in the 3.0
mg TID arm and cytisinicline was well-tolerated with no serious
adverse events reported.
Cytisinicline Data Accepted for Presentation
Data from
the Phase 2b ORCA-1 trial has been
accepted for oral presentation at the SRNT-E Annual Conference, to
be held in Oslo, September 12-14, 2019. The abstract "A
Multicenter, Double-blind, Randomized, Placebo-controlled Phase
2b Trial of Cytisinicline in Adult
Smokers" and two, oral presentations will include updated
cytisinicline data from the recently completed trial.
Patent Granted in the U.S. for Novel Formulation of
Cytisinicline
The U.S. Patent and Trademark Office has
granted Achieve a patent on succinate salt of cytisinicline and use
thereof. The patent covers a novel salt form of cytisinicline,
namely cytisinicline succinate, and pharmaceutical compositions and
dosage forms. Achieve has been pursuing cytisinicline succinate
salt as a novel new drug product formulation that may further
enhance cytisinicline product stability and long-term potency.
Received $4.2 Million from
Exercise of Warrants
Achieve announced that it had entered
into an agreement with a single investor to exercise outstanding
warrants that provided an aggregate of $4.2
million in total proceeds. In exchange for the warrant
exercise, Achieve issued to the investor a new warrant, exercisable
for six years, to purchase up to 1,200,000 shares of Common Stock
at an exercise price of $4.50 per
share. The Company filed an S-1 registration statement on
July 24, 2019 covering the resale of
the shares issuable upon exercise of the new warrant.
Financial Results
As of June
30, 2019, the company's cash, cash equivalents, and
restricted cash was $10.5 million.
Total operating expenses for the three and six months ended
June 30, 2019 were $3.7 million and $9.6
million, respectively. Total net loss for the three and six
months ended June 30, 2019 was
$3.6 million and $9.5 million, respectively.
As of August 8, 2019 Achieve had
8,097,763 shares outstanding.
Conference Call Details
Achieve will host a conference
call at 4:30 p.m. Eastern time today,
Thursday, August 8, 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 6587726. 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
June 30,
|
|
Three months ended
June 30,
|
|
|
2019
|
|
2017
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
2,032
|
|
1,045
|
|
6,087
|
|
2,246
|
General and
administrative
|
|
1,630
|
|
1,751
|
|
3,515
|
|
3,564
|
Total operating expenses
|
|
3,662
|
|
2,796
|
|
9,602
|
|
5,810
|
Loss from
operations
|
|
(3,662)
|
|
(2,796)
|
|
(9,602)
|
|
(5,810)
|
Other income
(expense)
|
|
38
|
|
8
|
|
74
|
|
-
|
Net loss
|
|
$
(3,624)
|
|
$
(2,788)
|
|
$
(9,528)
|
|
$
(5,810)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.50)
|
|
$
(1.82)
|
|
$
(1.37)
|
|
$
(4.18)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares
|
|
7,189,672
|
|
1,529,532
|
|
6,956,722
|
|
1,389,209
|
Consolidated
Balance Sheets
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
|
|
2019
|
|
2018
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents, short term investments and restricted cash
|
|
|
|
|
|
$
10,496
|
|
$
14,654
|
Prepaid
expenses and other current assets
|
|
|
|
|
|
356
|
|
933
|
Property,
equipment and other assets
|
|
|
|
|
|
256
|
|
153
|
Operating
lease right-of-use assets
|
|
|
|
|
|
414
|
|
—
|
License
agreement
|
|
|
|
|
|
2,199
|
|
2,310
|
Goodwill
|
|
|
|
|
|
1,034
|
|
1,034
|
Total
assets
|
|
|
|
|
|
$
14,755
|
|
$
19,084
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
|
|
|
|
$
2,796
|
|
$
3,259
|
Current
portion of long-term obligations
|
|
|
|
|
|
16
|
|
11
|
Current
portion of long-term lease liability
|
|
|
|
|
|
176
|
|
—
|
Long-term
obligations
|
|
|
|
|
|
20
|
|
12
|
Long-term
lease liability
|
|
|
|
|
|
243
|
|
—
|
Stockholders'
equity
|
|
|
|
|
|
11,504
|
|
15,802
|
Total liabilities and
stockholders' equity
|
|
|
|
|
|
$
14,755
|
|
$
19,084
|
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SOURCE Achieve Life Sciences, Inc.