SEATTLE and VANCOUVER, British Columbia, March 14, 2019 /PRNewswire/ -- 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 fourth
quarter and year-end 2018 financial results.
Recent Highlights
- Completion of enrollment in 254-subject Phase 2b ORCA-1 trial of cytisinicline in U.S.
smokers
- Presented final data from cytisinicline Phase 1/2 multi-dose,
pharmacokinetic and pharmacodynamics (PK/PD) study at the Society
for Research on Nicotine & Tobacco (SRNT) Annual Meeting
- Initiated a trial to assess the maximum tolerated dose, or MTD,
for a single administered oral dose of cytisinicline
- Pediatric waiver agreed by the U.S. Food and Drug
Administration (FDA)
- Closed registered direct offering for gross proceeds of
$5.6 million
Rick Stewart, Chairman and Chief
Executive Officer of Achieve Life Sciences commented, "The
cytisinicline development program continues to advance rapidly and
we are well-poised for continued success in 2019. As demonstrated
by the swift enrollment in our Phase 2b trial, new treatments are desperately needed
to help the millions of people who desire to quit smoking."
ORCA-1 Phase 2b Trial Fully
Enrolled
In February, Achieve announced completion of
enrollment of 254 smokers in a Phase 2b trial 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 is being conducted
at eight centers across the U.S. and results are expected in
mid-2019.
PK/PD Study Results Demonstrating Impressive Smoking
Cessation Rates
The study evaluated the repeat-dose PK and
PD effects of 1.5 mg and 3.0 mg cytisinicline in 26
healthy volunteer smokers when administered over the standard
25-day course of treatment. All subjects had a significant and
immediate reduction in cigarettes smoked within 2 days of
initiating cytisinicline treatment. By Day 26, subjects had an
average 80% reduction in cigarettes smoked, 82% reduction in
expired carbon monoxide (CO), and 46% had stopped smoking.
MTD Study Initiation
In March, Achieve
initiated a trial to assess the MTD for a single administered oral
dose of cytisinicline. This study will be performed in smokers who
will receive one single dose of cytisinicline. The dosage of
cytisinicline will be increased in separate groups of subjects per
dose level until stopping criteria are reached, based on the
occurrence of dose-limiting adverse events.
FDA Agrees to Full Waiver for Pediatric Population
FDA confirmed that they are in agreement with Initial Pediatric
Study Plan, specifically, providing a full waiver for evaluating
cytisinicline in a pediatric population. The reasons for the full
waiver were based on the low numbers of children smoking under the
age of 12 and the logistical difficulties of recruiting
treatment-seeking smokers in the adolescent age group. The agreed
Pediatric Study Plan will be included as part of Achieve's future
application for marketing approval of cytisinicline.
Completed $5.6M
Financing
In October 2018,
Achieve announced the closing of a registered direct offering that
raised total gross proceeds of $5.6
million and after deducting approximately $0.6 million in placement agent fees and offering
expenses, receiving net proceeds of $5.0
million.
Financial Results
As of December 31, 2018, the company's cash, cash
equivalents, short-term investments and restricted cash were
$14.7 million. Total operating
expenses for the fourth quarter and year ended December 31, 2018 were $3.7 million and $12.8
million, respectively. Total net loss for the fourth quarter
and year ended December 31, 2018 was
$3.6 million and $12.7 million, respectively.
As of March 14, 2019 Achieve had
6,721,200 shares outstanding.
Conference Call Details
Achieve will host a
conference call at 4:30 p.m. Eastern
time today, Thursday, March 14,
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 2057479. 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, 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 law.
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
December 31,
|
|
Twelve months
ended December 31,
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
2,081
|
|
2,153
|
|
5,868
|
|
3,101
|
General and
administrative
|
|
1,628
|
|
1,629
|
|
6,945
|
|
3,531
|
Total operating expenses
|
|
3,709
|
|
3,782
|
|
12,813
|
|
6,632
|
Loss from
operations
|
|
(3,709)
|
|
(3,782)
|
|
(12,813)
|
|
(6,632)
|
Other income
(expense)
|
|
72
|
|
42
|
|
126
|
|
(7,002)
|
Net loss before
income taxes
|
|
$
(3,637)
|
|
$
(3,740)
|
|
$
(12,687)
|
|
$
(13,634)
|
Recovery of
deferred income taxes
|
|
—
|
|
—
|
|
—
|
|
3,051
|
Net loss
|
|
$
(3,637)
|
|
$
(3,740)
|
|
$
(12,687)
|
|
$
(10,583)
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
(0.55)
|
|
$
(3.17)
|
|
$
(3.61)
|
|
$
(22.07)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares
|
|
6,659,379
|
|
1,179,812
|
|
3,510,217
|
|
479,442
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheets
|
(In
thousands)
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
2018
|
|
2017
|
|
|
|
|
|
Assets:
|
|
|
|
|
Cash, cash
equivalents, short term investments and restricted cash
|
|
$
14,654
|
|
$
5,556
|
Prepaid
expenses and other current assets
|
|
933
|
|
402
|
Property,
equipment and other assets
|
|
153
|
|
368
|
License
agreement
|
|
2,310
|
|
2,532
|
Goodwill
|
|
1,034
|
|
1,034
|
Total
assets
|
|
$
19,084
|
|
$
9,892
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
$
3,259
|
|
$
1,986
|
Current portion of
long-term obligations
|
|
11
|
|
27
|
Long-term
obligations, less current portion
|
|
12
|
|
—
|
Stockholders'
equity
|
|
15,802
|
|
7,879
|
Total liabilities and
stockholders' equity
|
|
$
19,084
|
|
$
9,892
|
|
|
|
|
|
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SOURCE Achieve Life Sciences, Inc.