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 dependence, today announced fourth quarter and year-end
2022 financial results and provided an update on the cytisinicline
development program.
Recent Highlights
- Presented additional analyses from
the Phase 3 ORCA-2 trial at the Society for Research on Nicotine
and Tobacco (SRNT) Annual Meeting
- Announced accomplishment of key
milestones, including last subject dosing and last subject visit,
in the Phase 2 ORCA-V1 trial evaluating cytisinicline for
e-cigarette cessation
- Completed dosing of final subject
in the Phase 3 ORCA-3 trial of cytisinicline for smoking
cessation
- Granted patent by United States
Patent and Trademark Office (USPTO) for new cytisinicline
formulation
- Closed financing of $18.9 million,
prior to deducting placement agent commissions and estimated
offering expenses
John Bencich, Chief Executive Officer of
Achieve, commented, “We believe that cytisinicline has the
potential to help millions of people overcome their dependence to
nicotine, and ultimately, live better and healthier lives. We will
continue to honor our commitment to the patients we serve, and the
numerous stakeholders who share our confidence in cytisinicline, by
delivering on our key milestones in the year ahead. We look forward
to 2023 being the most pivotal and exciting year yet for
Achieve.”
Phase 3 ORCA-2 Trial of Cytisinicline
Presented at SRNT New analyses from the ORCA-2 trial were
presented as part of the “Novel Treatments for Smoking Cessation”
session held March 3, 2023, at the Annual SRNT Meeting. The
presentation, given by ORCA-2 Principal Investigator, Dr. Nancy
Rigotti, highlighted successful abstinence rates observed in
subgroups of smokers who received cytisinicline, regardless of age,
gender, smoking history, or previous quit attempts. Additional
findings also demonstrated consistently higher rates of abstinence
in subjects who received either 6 or 12-weeks of cytisinicline,
compared to placebo. The higher rates of abstinence were maintained
throughout study treatment and during the 24-week follow-up
period.
Phase 2 ORCA-V1 Last Subject Dosed/Last
Subject Visit Completed In January 2023 and February 2023,
the final subject was dosed, and the last subject last visit was
completed, respectively, in the ongoing Phase 2 ORCA-V1 trial. The
ORCA-V1 trial, which is partially funded by the National Institute
of Health (NIH), enrolled 160 adult users of nicotine e-cigarettes,
or vapes, across five clinical trial locations in the United
States. Participants were randomized in this two-arm trial to
either receive 3 mg of cytisinicline three-times daily, or placebo
for a period of 12 weeks. The primary outcome assessment is
continuous vaping abstinence during the final four weeks of
treatment. It was announced in early November 2022 that target
enrollment in the trial was achieved ahead of schedule. Topline
results are expected in the second quarter of 2023.
Phase 3 ORCA-3 Last Subject
DosedThe last subject was dosed in the second Phase 3
ORCA-3 trial in January 2023. The two-arm trial randomized 792
subjects across 20 clinical trial locations in the United States.
Subjects are monitored through 24 weeks post randomization and
receive standard behavioral support for the duration of treatment.
Similar to the previously reported ORCA-2 trial, ORCA-3 is
evaluating the smoking cessation efficacy, safety, and tolerability
of 3 mg cytisinicline dosed three times daily for either 6 or 12
weeks compared with placebo. Topline results are expected in the
second quarter of 2023.
Patent Granted by USPTO for New
Cytisinicline FormulationIn December 2022, the USPTO
issued U.S. Patent No. 11,459,328, which covers the mesylate salt
formulation of cytisinicline and the process for its development.
Achieve now has 15 patents and 46 pending patenting, including
expirations extending out until 2042.
Private Placement of $18.9
MillionIn November 2022, Achieve entered into a definitive
agreement for a private placement of its securities for gross
proceeds of approximately $18.9 million, prior to deducting
placement agent commissions and estimated offering expenses.
Participating in the private placement was a new life science
focused investment fund, Achieve’s management, and existing
investors. The proceeds of the placement are being used to fund the
ongoing trials, research and development, and for general working
capital.
Financial ResultsAs of December
31, 2022, the company’s cash, cash equivalents, and restricted cash
was $24.8 million. Total operating expenses for the fourth quarter
and year ended December 31, 2022 were $10.9 million and $40.8
million, respectively. Total net loss for the fourth quarter and
year ended December 31, 2022 was $11.2 million and $42.4 million,
respectively. As of March 16, 2023 Achieve had 17,930,362 shares
outstanding.
Conference Call DetailsAchieve
will host a conference call at 4:30 PM EDT today, Thursday, March
16, 2023. 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) 269-7756 (U.S. & Canada) or (201) 689-7817
(International) and referencing conference ID 13736451. 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 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 9 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
ContactNicole Jonesachv@cg.capital(404)
736-3838Media ContactGlenn
SilverGlenn.Silver@Finnpartners.com(646) 871-8485
References1World Health
Organization. WHO Report on the Global Tobacco Epidemic, 2019.
Geneva: World Health Organization, 2017.2U.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,
Loretan CG, Wang TW, Jamal A, Homa DM. Tobacco Product Use Among
Adults — United States, 2020. MMWR Morb Mortal Wkly Rep
2022;71:397–405. 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 December 31, |
|
Twelve months ended December 31, |
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
8,614 |
|
|
|
4,506 |
|
|
|
30,078 |
|
|
|
23,966 |
|
General and administrative |
|
|
|
2,248 |
|
|
|
2,609 |
|
|
|
10,722 |
|
|
|
9,128 |
|
Total operating expenses |
|
|
|
10,862 |
|
|
|
7,115 |
|
|
|
40,800 |
|
|
|
33,094 |
|
Loss from operations |
|
|
|
(10,862 |
) |
|
|
(7,115 |
) |
|
|
(40,800 |
) |
|
|
(33,094 |
) |
Other income (expense) |
|
|
|
(370 |
) |
|
|
(36 |
) |
|
|
(1,550 |
) |
|
|
(58 |
) |
Net loss |
|
|
$ |
(11,232 |
) |
|
$ |
(7,151 |
) |
|
$ |
(42,350 |
) |
|
$ |
(33,152 |
) |
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
share |
|
|
$ |
(0.83 |
) |
|
$ |
(0.76 |
) |
|
$ |
(4.00 |
) |
|
$ |
(4.08 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of
basic and diluted common shares |
|
|
|
13,536,944 |
|
|
|
9,453,542 |
|
|
|
10,593,034 |
|
|
|
8,119,836 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheets |
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
|
|
$ |
24,771 |
|
|
$ |
43,022 |
|
Prepaid expenses and other current assets |
|
|
|
|
|
|
|
2,559 |
|
|
|
1,572 |
|
Other assets and restricted cash |
|
|
|
|
|
|
|
66 |
|
|
|
183 |
|
Right-of-use assets |
|
|
|
|
|
|
|
123 |
|
|
|
64 |
|
License agreement |
|
|
|
|
|
|
|
1,418 |
|
|
|
1,641 |
|
Goodwill |
|
|
|
|
|
|
|
1,034 |
|
|
|
1,034 |
|
Total assets |
|
|
|
|
|
|
$ |
29,971 |
|
|
$ |
47,516 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders'
equity: |
|
|
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
|
|
|
|
$ |
5,470 |
|
|
$ |
4,481 |
|
Current portion of long-term obligations |
|
|
|
|
|
|
|
58 |
|
|
|
69 |
|
Convertible debt |
|
|
|
|
|
|
|
16,071 |
|
|
|
14,920 |
|
Long-term obligations |
|
|
|
|
|
|
|
69 |
|
|
|
4 |
|
Stockholders' equity |
|
|
|
|
|
|
|
8,303 |
|
|
|
28,042 |
|
Total liabilities and
stockholders' equity |
|
|
|
|
|
|
$ |
29,971 |
|
|
$ |
47,516 |
|
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