Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical
pharmaceutical company committed to the global development and
commercialization of cytisinicline for smoking cessation and
nicotine addiction, today announced second quarter 2022 financial
results and provided an update on the cytisinicline clinical
development program.
Recent Events & Highlights
- Reported statistically significant results from the Phase 3
ORCA-2 clinical trial of cytisinicline in 810 adult smokers
- Awarded $2.5 million grant from the National Institutes of
Health (NIH) to conduct ORCA-V1 Phase 2 trial of cytisinicline in
nicotine e-cigarette users
- Initiated the Phase 2 ORCA-V1 clinical trial to evaluate
cytisinicline in adult e-cigarette users
“We continue to build upon the progress of cytisinicline with
the announcement of the initiation of the ORCA-V1 trial and the
continued enrolment in ORCA-3, our final NDA-enabling smoking
cessation clinical trial,” stated John Bencich, CEO of Achieve Life
Sciences. “We remain focused on executing on our milestones and
potentially expanding cytisinicline to e-cigarette and vaping users
who currently have no FDA-approved cessation
treatments.”Reported Phase 3 ORCA-2 ResultsIn
April, Achieve announced positive, statistically significant
results in its Phase 3 ORCA-2 clinical trial of cytisinicline in
810 adult smokers across 17 clinical trial locations in the United
States. ORCA-2 evaluated the efficacy and safety of 3mg of
cytisinicline dosed 3 times daily for either 6 or 12-weeks compared
to placebo in adult smokers. Both the primary and secondary
endpoints demonstrated increased quit rates, showing 6-8 times
increased odds of smoking abstinence when compared to placebo.
Cytisinicline was well tolerated with single-digit rates of adverse
events observed and no treatment-related serious adverse events
reported.
Awarded $2.5 Million from NIH for Phase 2 ORCA-V1
TrialIn June, Achieve was awarded $2.5 million in grant
funding from the NIH to evaluate the use of cytisinicline as a
treatment for cessation of nicotine e-cigarette use. In total, $2.8
million has been awarded and is expected to cover approximately
half of the ORCA-V1 trial costs.
Initiated Phase 2 ORCA-V1 TrialAlso in June,
following the NIH grant award, Achieve initiated the ORCA-V1
clinical trial across five trial locations in the United States.
Approximately 150 participants are planned to be randomized to
receive 3mg of cytisinicline 3 times daily or placebo for 12 weeks
in combination with standard behavioral support.
Financial ResultsAs of June 30, 2022, the
company’s cash, cash equivalents, and restricted cash were $29.4
million. Total operating expenses for the three and six months
ended June 30, 2022 were $10.1 million and $17.3 million,
respectively. Total net loss for the three and six months ended
June 30, 2022 was $10.5 million and $18.0 million,
respectively.
As of August 11, 2022, Achieve had 9,681,855 shares
outstanding.Conference Call DetailsAchieve will
host a conference call at 4:30 PM EDT, Thursday, August 11, 2022.
To access the webcast, please use the following link 2Q22 Earnings
Webcast. Alternatively, you may access the live conference call by
dialing (888) 645-4404 (Domestic) or (404) 267-0371 (International)
and referencing conference ID 13731865. A webcast replay will be
available approximately three hours after the call and will be
archived on the website for 90 days.
About Achieve and Cytisinicline Achieve’s focus
is to address the global smoking health and nicotine addiction
epidemic through the development and commercialization of
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 United
States 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.2In addition, there are nearly 11 million adults in the
United States who use e-cigarettes, also known as vaping.3 While
nicotine e-cigarettes are thought to be less harmful than
combustible cigarettes, they remain addictive and can deliver
harmful chemicals which can cause lung injury or cardiovascular
disease.4 In 2021, e-cigarettes were the most commonly used tobacco
product reported by 1.72 million high school students.5 Research
shows adolescents who have used e-cigarettes are seven times more
likely to become smokers one year later compared to those who have
never vaped.6 Currently, there are no FDA-approved treatments
indicated specifically as an aid to nicotine e-cigarette
cessation.Cytisinicline is a plant-based alkaloid with a high
binding affinity to the nicotinic acetylcholine receptor. It is
believed to aid in treating nicotine addiction for smoking and
e-cigarette cessation by interacting with nicotine receptors in the
brain, reducing the severity of withdrawal symptoms, and reducing
the reward and satisfaction associated with nicotine products.
Cytisinicline is an investigational product candidate being
developed for treatment of nicotine addiction and has not been
approved by the Food and Drug Administration for any indication in
the United States. For more information on cytisinicline and
Achieve visit www.achievelifesciences.com.
Forward Looking StatementsThis 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, data
results and commercialization activities, the potential market size
for cytisinicline, the potential benefits, safety and tolerability
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.
Investor Relations ContactRich
Cockrellachv@cg.capital (404) 736-3838
Media ContactGlenn
SilverGlenn.Silver@Finnpartners.com (646) 871-8485
References1 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, 2014.3Cornelius ME, Wang TW, Jamal A,
Loretan CG, Neff LJ. Tobacco Product Use Among Adults — United
States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:1736–1742. DOI:
10.15585/mmwr.mm6946a4.4Ogunwale, Mumiye A et al. (2017) Aldehyde
Detection in Electronic Cigarette Aerosols. ACS omega 2(3):
1207-1214. DOI: 10.1021/acsomega.6b00489].5Gentzke AS, Wang TW,
Cornelius M, et al. Tobacco Product Use and Associated Factors
Among Middle and High School Students – National Youth Tobacco
Survey, United States, 2021. MMWR Surveill Summ 2022;71(no.
SS-5):1-29. DOI: 10.15585/mmwr.ss7105a1.6Elizabeth C. Hair, Alexis
A. Barton, Siobhan N. Perks, Jennifer Kreslake, Haijun Xiao,
Lindsay Pitzer, Adam M. Leventhal, Donna M. Vallone, Association
between e-cigarette use and future combustible cigarette use:
Evidence from a prospective cohort of youth and young adults,
2017–2019, Addictive Behaviors, Volume 112, 2021, 106593, ISSN
0306-4603. DOI: 10.1016/j.addbeh.2020.106593.
|
Consolidated Statements of Loss |
(In thousands, except per share and share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
7,207 |
|
|
|
9,227 |
|
|
|
11,595 |
|
|
|
14,869 |
|
General and administrative |
|
2,866 |
|
|
|
2,075 |
|
|
|
5,704 |
|
|
|
4,417 |
|
Total operating expenses |
|
10,073 |
|
|
|
11,302 |
|
|
|
17,299 |
|
|
|
19,286 |
|
Loss from operations |
|
(10,073 |
) |
|
|
(11,302 |
) |
|
|
(17,299 |
) |
|
|
(19,286 |
) |
Other income (expense) |
|
(395 |
) |
|
|
(9 |
) |
|
|
(742 |
) |
|
|
(24 |
) |
Net loss |
$ |
(10,468 |
) |
|
$ |
(11,311 |
) |
|
$ |
(18,041 |
) |
|
$ |
(19,310 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
$ |
(1.08 |
) |
|
$ |
(1.53 |
) |
|
$ |
(1.89 |
) |
|
$ |
(2.85 |
) |
|
|
|
|
|
|
|
|
Weighted average number of
basic and diluted common shares |
|
9,647,726 |
|
|
|
7,390,600 |
|
|
|
9,553,757 |
|
|
|
6,764,688 |
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheets |
(In thousands) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
29,378 |
|
|
$ |
43,022 |
|
Prepaid expenses and other current assets |
|
|
1,770 |
|
|
|
1,572 |
|
Other assets and restricted cash |
|
|
240 |
|
|
|
183 |
|
Right-of-use assets |
|
|
33 |
|
|
|
64 |
|
License agreement |
|
|
1,530 |
|
|
|
1,641 |
|
Goodwill |
|
|
1,034 |
|
|
|
1,034 |
|
Total assets |
|
$ |
33,985 |
|
|
$ |
47,516 |
|
|
|
|
|
|
Liabilities and stockholders'
equity: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
5,318 |
|
|
$ |
4,481 |
|
Current portion of long-term obligations |
|
|
41 |
|
|
|
69 |
|
Convertible debt |
|
|
15,460 |
|
|
|
14,920 |
|
Long-term obligations |
|
|
— |
|
|
|
4 |
|
Stockholders' equity |
|
|
13,166 |
|
|
|
28,042 |
|
Total liabilities and
stockholders' equity |
|
$ |
33,985 |
|
|
$ |
47,516 |
|
|
|
|
|
|
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