Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage
pharmaceutical company committed to the global development and
commercialization of cytisinicline for smoking cessation and
nicotine dependence, today announced third quarter 2023 financial
results and provided an update on the cytisinicline development
program.
Recent Business Highlights
- Announced publication of cytisinicline Phase 3 ORCA-2 smoking
cessation trial in Journal of the American Medical Association
(JAMA)
- Presented Phase 2 ORCA-V1 results at Society for Research on
Nicotine and Tobacco Europe (SRNT-E)
- Participated in panel presentation at the American Society of
Pharmacognosy (ASP) Annual Meeting
- Completed dosing of subjects in three ongoing NDA-supportive
clinical studies
“This has been a pivotal year for Achieve and we made
significant strides to continue our progress on advancing
cytisinicline throughout the third quarter,” said John Bencich, CEO
of Achieve. “Our primary focus remains on fulfilling FDA
requirements to enable the submission of a New Drug Application for
cytisinicline and engaging with partners who align with our vision
for the substantial public health benefits of
cytisinicline.”
ORCA-2 JAMA
PublicationResults from the Phase 3 ORCA-2 trial
were published in JAMA in July 2023. This trial, conducted in the
United States, showcased the effectiveness and excellent
tolerability of cytisinicline in adult smokers. Notably,
cytisinicline exhibited significantly higher rates of biochemically
verified smoking cessation when compared to a placebo, irrespective
of whether the treatment lasted for 6 or 12 weeks. The rates of
sustained abstinence remained statistically significant for up to 6
months and cytisinicline was well-tolerated. Additionally, the
publication offered supplementary data indicating that individuals
using cytisinicline experienced a swift and lasting reduction in
cravings and the desire to smoke in contrast to those on the
placebo during the initial 6 weeks of the treatment period.
ORCA-V1 SRNT-E PresentationPhase 2 ORCA-V1
positive results were presented at the SRNT-E Annual Meeting. The
presentation emphasized the primary endpoint analysis, revealing
that 3 mg of cytisinicline administered three times daily for 12
weeks yielded a 2.6-fold (p=0.035) increase in the likelihood of
vaping cessation compared to a placebo among 160 daily nicotine
vape users. Additional analyses presented indicated that vaping
abstinence with cytisinicline treatment commenced during the second
treatment week, with the odds of vaping cessation progressively
improving throughout the 12-week treatment period. Similar to
previous trials conducted in smoking cessation, cytisinicline
treatment was well tolerated with only insomnia and abnormal dreams
trending higher when compared to placebo, while rates of nausea and
headache were lower for the 12-week cytisinicline treatment arm
than observed in the placebo arm.
ASP Panel PresentationAchieve management, John
Bencich, Chief Executive Officer, and Richard Stewart, Executive
Chairman of the Board of Directors, presented on a panel discussion
“SEEDing Biomedical Innovation: Support for Small Businesses at
National Institute of Health” at the 2023 American Society of
Pharmacognosy (ASP) Annual Meeting. The panel highlighted the
importance of industry and public partnerships in advancing new
treatments, with Achieve representing an exemplary example.
Clinical Study Completion Achieve has now
completed recruitment and dosing of three NDA-supportive clinical
studies evaluating QT interval prolongation, steady-state
pharmacokinetics in smokers, and pharmacokinetics parameters in
subjects with renal impairment. Data analysis and final study
reports for all 3 studies are expected to be completed in early
2024.
Financial ResultsAs of September 30, 2023, the
company’s cash, cash equivalents, and restricted cash was $20.0
million. Total operating expenses for the three and nine months
ended September 30, 2023 were $6.6 million and $22.9 million,
respectively. Total net loss for the three and nine months ended
September 30, 2023 was $7.1 million and $24.3 million,
respectively. As of November 9, 2023, Achieve had 21,165,760 shares
outstanding.
Conference Call DetailsAchieve will host a
conference call at 4:30 PM EST Thursday, November 9, 2023. To
access the webcast, log on to the investor relations page of the
Achieve website and use the following link 3Q23 Earnings
Webcast. Alternatively, access to the live conference call
is available by dialing (877) 269-7756 (U.S. & Canada) or (201)
689-7817 (International) and referencing conference ID 13741438. 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 CytisiniclineAchieve’s focus
is to address the global smoking health and nicotine addiction
epidemic through the development and commercialization of
cytisinicline. There are an estimated 28 million adults in the
United States alone who smoke combustible cigarettes.1 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.2,3 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.3
In addition, there are over 11 million adults in the United
States who use e-cigarettes, also known as vaping.3 In 2023,
approximately 2.1 million middle and high school students in the
United States reported using e-cigarettes.4 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 the 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, efficacy, 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 macroeconomic conditions,
including inflation, rising interest rates, instability in the
global banking sector, and public health crises, such as the
COVID-19 pandemic 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 ContactNicole
Jonesachv@cg.capital(404) 736-3842
Media ContactGlenn
SilverGlenn.Silver@Finnpartners.com(646) 871-8485
References1Cornelius ME, Loretan CG, Jamal A,
et al. Tobacco Product Use Among Adults – United States, 2021. MMWR
Morb Mortal Wkly Rep 2023;72:475–483.2World Health Organization.
WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World
Health Organization, 2017.3U.S. Department of Health and Human
Services. The Health Consequences of Smoking – 50 Years of
Progress. A Report of the Surgeon General, 2014.4Birdsey J,
Cornelius M, Jamal A, et al. Tobacco Product Use Among U.S. Middle
and High School Students — National Youth Tobacco Survey, 2023.
MMWR Morb Mortal Wkly Rep 2023;72:1173–1182.
Consolidated Statements of Loss |
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(In thousands, except per share and share
data) |
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Three months ended September 30, |
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Nine months ended September 30, |
|
|
|
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2023 |
|
|
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2022 |
|
|
|
2023 |
|
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|
2022 |
|
|
|
|
|
|
|
|
|
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|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
3,581 |
|
|
|
9,869 |
|
|
|
13,700 |
|
|
|
21,464 |
|
|
General and administrative |
|
|
|
2,991 |
|
|
|
2,770 |
|
|
|
9,164 |
|
|
|
8,474 |
|
|
Total operating expenses |
|
|
|
6,572 |
|
|
|
12,639 |
|
|
|
22,864 |
|
|
|
29,938 |
|
|
Loss from operations |
|
|
|
(6,572 |
) |
|
|
(12,639 |
) |
|
|
(22,864 |
) |
|
|
(29,938 |
) |
|
Other income (expense) |
|
|
|
(536 |
) |
|
|
(438 |
) |
|
|
(1,475 |
) |
|
|
(1,180 |
) |
|
Net loss |
|
|
$ |
(7,108 |
) |
|
$ |
(13,077 |
) |
|
$ |
(24,339 |
) |
|
$ |
(31,118 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
|
$ |
(0.34 |
) |
|
$ |
(1.35 |
) |
|
$ |
(1.26 |
) |
|
$ |
(3.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of basic and diluted common shares |
|
|
|
21,127,281 |
|
|
|
9,693,788 |
|
|
|
19,376,316 |
|
|
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9,600,947 |
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Consolidated Balance Sheets |
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(In thousands) |
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September 30, |
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December 31, |
|
|
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2023 |
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|
2022 |
|
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Assets: |
|
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Cash and cash equivalents |
|
|
|
|
|
|
$ |
19,919 |
|
|
$ |
24,771 |
|
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
1,978 |
|
|
|
2,559 |
|
|
Other assets and restricted cash |
|
|
|
|
|
|
|
74 |
|
|
|
123 |
|
|
Right-of-use assets |
|
|
|
|
|
|
|
80 |
|
|
|
66 |
|
|
License agreement |
|
|
|
|
|
|
|
1,252 |
|
|
|
1,418 |
|
|
Goodwill |
|
|
|
|
|
|
|
1,034 |
|
|
|
1,034 |
|
|
Total assets |
|
|
|
|
|
|
$ |
24,337 |
|
|
$ |
29,971 |
|
|
|
|
|
|
|
|
|
|
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|
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Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
|
|
|
|
$ |
4,021 |
|
|
$ |
5,470 |
|
|
Current portion of long-term obligations |
|
|
|
|
|
|
|
61 |
|
|
|
58 |
|
|
Convertible debt |
|
|
|
|
|
|
|
16,195 |
|
|
|
16,071 |
|
|
Long-term obligations |
|
|
|
|
|
|
|
22 |
|
|
|
69 |
|
|
Stockholders' equity |
|
|
|
|
|
|
|
4,038 |
|
|
|
8,303 |
|
|
Total liabilities and stockholders' equity |
|
|
|
|
|
|
$ |
24,337 |
|
|
$ |
29,971 |
|
|
|
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