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 fourth quarter and year-end
2023 financial results and provided an update on the cytisinicline
development program.
Recent Highlights
- Announced Company reached agreement with the U.S. Food and Drug
Administration (FDA) on long-term cytisinicline exposure
requirements to support a New Drug Application (NDA)
submission
- Completed an equity financing of up to $124.2 million that
included initial upfront gross proceeds of $60.0 million, prior to
deducting placement agent fees and estimated offering expenses, and
up to an additional approximately $64.2 million of gross proceeds
upon exercise of milestone-driven warrants
- Presented data from Phase 3 ORCA-2 and ORCA-3 trials, and Phase
2 ORCA-V1 trial at Society for Research on Nicotine and Tobacco
(SRNT)
John Bencich, Achieve’s Chief Executive Officer, commented,
“2023 marked a significant turning point for Achieve as we
accomplished several key milestones, such as repeating successful
efficacy and safety outcomes in the second Phase 3 ORCA-3 trial for
smoking cessation, positive data from the Phase 2 ORCA-V1 trial for
vaping, and significant progress in our discussions with the FDA to
further our goal of bringing cytisinicline forward to aid the
millions of individuals who are seeking treatment for nicotine
dependence. We are appreciative of the strong support and
confidence from our stakeholders, including new investors who
participated in the recent financing and smoking cessation opinion
leaders who share in our enthusiasm for cytisinicline’s
potential.”
FDA Agreement on NDA Submission Requirement
Achieve and the FDA have reached agreement that a single,
open-label study evaluating for long-term safety exposure of
cytisinicline will be sufficient to complete the requirement and
enable an NDA submission anticipated in the first half of 2025.
Achieve plans to initiate the “ORCA-OL” open-label exposure trial
in the second quarter of 2024, which will include investigators and
sites who have participated in the ORCA clinical trial program
(ORCA-2, ORCA-3, and ORCA-V1 studies).
Completed Registered Direct Offering and Concurrent
Private Placement The Company completed an equity
financing of up to $124.2 million that included initial upfront
gross proceeds of $60.0 million, prior to deducting placement agent
fees and estimated offering expenses, and up to an additional
approximately $64.2 million gross proceeds upon exercise of
milestone-driven warrants. Achieve expects proceeds from the
registered direct offering and concurrent private placement,
assuming the exercise of all of the milestone-driven warrants, will
be sufficient to fund its development of cytisinicline into 2026
and through potential FDA approval.
ORCA-2, ORCA-3 and ORCA-V1 Data Presented at Annual SRNT
ConferenceDuring the Annual Society for Research on
Nicotine and Tobacco conference in March, the Company had three
cytisinicline clinical data abstracts selected for podium
presentation. The selected abstracts covered data from the Phase 3
ORCA-2 and ORCA-3 trials, alongside the Phase 2 ORCA-V1 trial, and
presented compelling evidence on the potential efficacy and safety
of cytisinicline for smoking and vaping cessation.
Results presented from the Phase 3 participant surveys, showed
that 69% of survey respondents who received cytisinicline reported
quitting smoking completely. For those on treatment that did not
achieve full smoking abstinence, 22% reported a reduction of their
smoking by over half. Nearly all participants who quit smoking
attributed their success to cytisinicline and cited fewer cravings
and tolerable side effects as the main reasons. Additionally, 97%
reported they would recommend cytisinicline to others. The ORCA-3
trial further validated these survey results, demonstrating higher
smoking abstinence rates with cytisinicline compared to placebo,
without increased relapse risk after transitioning to placebo.
Furthermore, the ORCA-V1 trial explored cytisinicline's potential
in vaping cessation among 160 e-cigarette users, showing a
significant increase in abstinence rates compared to placebo, with
minimal side effects.
Financial ResultsAs of December 31, 2023, the
Company’s cash, cash equivalents, and restricted cash was $15.6
million. After giving effect to the February 2024 equity financing
the Company’s pro forma cash, cash equivalents, and restricted cash
as of December 31, 2023, would have been $71.8 million. Total
operating expenses for the fourth quarter and year ended December
31, 2023 were $4.4 million and $27.3 million, respectively. Total
net loss for the fourth quarter and year ended December 31, 2023
was $5.5 million and $29.8 million, respectively. As of March 28,
2024, Achieve had 34,251,911 shares outstanding.
Conference Call DetailsAchieve will host a
conference call at 4:30 PM EDT Thursday, March 28, 2024. To access
the webcast, log on to the investor relations page of the Achieve
website and use the following link 4Q23 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 13744140. 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. 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 and
regulatory review and approval, data results and commercialization
activities, the anticipated proceeds from outstanding
milestone-driven warrants, the sufficiency of Achieve’s capital
resources to fund the development of cytisinicline through
potential FDA approval, the 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) 736-3838
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 |
(In thousands, except per share and share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
Twelve months ended December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
2,114 |
|
|
|
8,614 |
|
|
|
15,814 |
|
|
|
30,078 |
|
General and administrative |
|
2,272 |
|
|
|
2,248 |
|
|
|
11,436 |
|
|
|
10,722 |
|
Total operating expenses |
|
4,386 |
|
|
|
10,862 |
|
|
|
27,250 |
|
|
|
40,800 |
|
Loss from operations |
|
(4,386 |
) |
|
|
(10,862 |
) |
|
|
(27,250 |
) |
|
|
(40,800 |
) |
Other income (expense) |
|
(1,090 |
) |
|
|
(370 |
) |
|
|
(2,565 |
) |
|
|
(1,550 |
) |
Net loss |
$ |
(5,476 |
) |
|
$ |
(11,232 |
) |
|
$ |
(29,815 |
) |
|
$ |
(42,350 |
) |
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
$ |
(0.26 |
) |
|
$ |
(0.83 |
) |
|
$ |
(1.50 |
) |
|
$ |
(4.00 |
) |
|
|
|
|
|
|
|
|
Weighted average number of basic and diluted common shares |
|
21,165,760 |
|
|
|
13,536,944 |
|
|
|
19,827,354 |
|
|
|
10,593,034 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Balance Sheets |
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
$ |
15,546 |
|
|
$ |
24,771 |
|
Prepaid expenses and other current assets |
|
|
|
|
|
1,436 |
|
|
|
2,559 |
|
Other assets and restricted cash |
|
|
|
|
|
92 |
|
|
|
66 |
|
Right-of-use assets |
|
|
|
|
|
66 |
|
|
|
123 |
|
License agreement |
|
|
|
|
|
1,197 |
|
|
|
1,418 |
|
Goodwill |
|
|
|
|
|
1,034 |
|
|
|
1,034 |
|
Total assets |
|
|
|
|
$ |
19,371 |
|
|
$ |
29,971 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity: |
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
|
|
|
$ |
4,088 |
|
|
$ |
5,470 |
|
Current portion of long-term obligations |
|
|
|
|
|
63 |
|
|
|
58 |
|
Convertible debt |
|
|
|
|
|
16,662 |
|
|
|
16,071 |
|
Long-term obligations |
|
|
|
|
|
6 |
|
|
|
69 |
|
Stockholders' equity |
|
|
|
|
|
(1,448 |
) |
|
|
8,303 |
|
Total liabilities and stockholders' equity |
|
|
|
|
$ |
19,371 |
|
|
$ |
29,971 |
|
|
|
|
|
|
|
|
|
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