SEATTLE and VANCOUVER, British Columbia, Aug. 6, 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 second quarter 2020 financial results and provided an
update on the cytisinicline clinical development program.
Recent Highlights
- Announced successful topline results from the investigator
initiated RAUORA head-to-head non-inferiority clinical trial
comparing cytisinicline and Chantix® (varenicline) as a treatment
to quit smoking
- Closed a Registered Direct Offering for gross proceeds
of approximately $6 million,
prior to deducting placement agent commissions and estimated
offering expenses
- Entered into an Underwritten Public Offering for estimated
gross proceeds of $7.5 million, prior
to deducting underwriting discounts and commissions and estimated
offering expenses. This financing is expected to close on or about
August 6, 2020, subject to the
satisfaction of customary closing conditions
- New patent granted in the U.S. for novel analogs of
cytisinicline for use in CNS and addiction indications
"It has been a busy and exciting quarter with new evidence
further reinforcing our belief that cytisinicline has the potential
to provide a more tolerable cessation treatment to millions of
smokers who want to quit," commented Rick
Stewart, Chairman and Chief Executive Officer of Achieve. We
continue to focus our efforts on initiation of the 750 patient
Phase 3 ORCA-2 trial in the second-half of 2020, subject to the
ability to conduct the trial safely in light of the COVID-19
pandemic."
Successful RAUORA Head-to-Head vs Chantix® Study
Results
Achieve announced the successful topline 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. The trial
achieved statistical significance in showing that cytisinicline
plus behavioral support was at least as effective as varenicline
plus behavioral support at six months. In addition, the trial
showed that cytisinicline resulted in significantly fewer reported
adverse events when compared to varenicline. The study was led by
Dr. Natalie Walker, Associate
Professor at the University of Auckland, and was funded by the Health
Research Council of New Zealand. The final RAUORA trial
results have been submitted for presentation at The Society for
Research on Nicotine and Tobacco Europe (SRNT-E) Annual Meeting in
September 2020.
Closed Registered Direct Offering for Gross Proceeds of
$6 million
Achieve entered
into a securities purchase agreement with certain institutional
investors providing for the purchase and sale of 731,707 shares of
common stock at a price of $8.20 per
share in a registered direct offering, resulting in total gross
proceeds of approximately $6 million,
prior to deducting placement agent fees and estimated offering
expenses. The financing was closed in early July 2020.
Entered into an Underwritten Public Offering for Gross
Proceeds of $7.5 million
On August 3, 2020, Achieve entered
into an Underwritten Public Offering to which it will sell 569,043
shares of common stock, including 92,856 shares subject to the
underwriters' option to purchase additional shares, at a price of
$10.50 per share, and 142,857
pre-funded warrants at a price of $10.499 per pre-funded warrant, which represents
the per share public offering price for the shares of common stock
less $0.001 per shares exercise price
for each pre-funded warrant. Total gross proceeds from the offering
are expected to be approximately $7.5
million, prior to deducting underwriting discounts and
commissions and estimated offering expenses. This financing is
expected to close on or about August 6,
2020, subject to the satisfaction of customary closing
conditions.
Patent Granted in the U.S. for Novel Analogs of
Cytisinicline
Achieve announced that the United States
Patent and Trademark Office has granted Achieve a patent on
derivatives of cytisinicline and use thereof. The newly patented
analogs provide the opportunity for selective targeting of nAChRs
in the brain in order to treat a number of conditions, such as
Alzheimer's disease, depression, anxiety, schizophrenia, epilepsy,
Parkinson's disease and addiction.
Financial Results
As of June
30, 2020, the company's cash, cash equivalents, and
restricted cash was $12.2 million,
exclusive of the funds from the July and August financings totaling
$13.5 million gross proceeds.
Total operating expenses for the three and six months ended
June 30, 2020 were $2.9 million and $6.3
million, respectively. Total net loss for the three and six
months ended June 30, 2020 was
$2.9 million and $6.2 million, respectively.
As of August 6, 2020, Achieve had
3,587,205 shares outstanding.
Conference Call Details
Achieve will host a
conference call at 4:30pm Eastern
time today, Thursday, August 6,
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 1661409. 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 more than eight million deaths annually
worldwide[1]. It is estimated that 28.7% of
cancer deaths in the U.S. are attributable to cigarette
smoking[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.
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 ability to
secure any non-dilutive financing, the timing and nature of
cytisinicline clinical development 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.
Achieve Contact
Jason
Wong
jwong@bplifescience.com
(415) 375-3340 ext. 4
Chantix® is a registered trademark of Pfizer Inc.
Consolidated
Statements of Loss
|
(In thousands,
except per share and share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
Six months ended
June 30,
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
1,103
|
|
2,032
|
|
2,644
|
|
6,087
|
General and
administrative
|
|
|
1,815
|
|
1,630
|
|
3,631
|
|
3,515
|
Total operating expenses
|
|
|
2,918
|
|
3,662
|
|
6,275
|
|
9,602
|
Loss from
operations
|
|
|
(2,918)
|
|
(3,662)
|
|
(6,275)
|
|
(9,602)
|
Other income
(expense)
|
|
|
(4)
|
|
38
|
|
33
|
|
74
|
Net loss
|
|
|
$
(2,922)
|
|
$
(3,624)
|
|
$
(6,242)
|
|
$
(9,528)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
$
(1.68)
|
|
$
(10.08)
|
|
$
(3.79)
|
|
$
(27.39)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares
|
|
|
1,744,014
|
|
359,484
|
|
1,645,426
|
|
347,836
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheets
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents, short term investments and restricted cash
|
|
|
|
|
|
|
$
12,161
|
|
$
16,714
|
Prepaid
expenses and other current assets
|
|
|
|
|
|
|
545
|
|
670
|
Property,
equipment and other assets
|
|
|
|
|
|
|
502
|
|
244
|
Right-of-use
assets
|
|
|
|
|
|
|
240
|
|
329
|
License
agreement
|
|
|
|
|
|
|
1,976
|
|
2,087
|
Goodwill
|
|
|
|
|
|
|
1,034
|
|
1,034
|
Total
assets
|
|
|
|
|
|
|
$
16,458
|
|
$
21,078
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
|
|
|
|
|
$
1,645
|
|
$
2,666
|
Current
portion of long-term obligations
|
|
|
|
|
|
|
165
|
|
203
|
Long-term
obligations
|
|
|
|
|
|
|
110
|
|
159
|
Stockholders'
equity
|
|
|
|
|
|
|
14,538
|
|
18,050
|
Total liabilities and
stockholders' equity
|
|
|
|
|
|
|
$
16,458
|
|
$
21,078
|
[1]World Health Organization. WHO Report on the
Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017
[2]Annals of Epidemiology, Volume 25, Issue 3, 179 -
182.e1
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SOURCE Achieve Life Sciences, Inc.