Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage
pharmaceutical company dedicated to the global development and
commercialization of cytisinicline for smoking cessation and
nicotine dependence, today announced its financial results for the
first quarter of 2024 and provided an update on the cytisinicline
development program.
Recent Highlights
- Published Phase 2 ORCA-V1 clinical trial results in the Journal
of the American Medical Association Internal Medicine (JAMA
IM)
- Advanced plans for the initiation of the long-term
cytisinicline exposure trial (ORCA-OL)
- Presented data from Phase 3 ORCA-2 and ORCA-3 trials, and Phase
2 ORCA-V1 trial at the Society for Research on Nicotine and Tobacco
(SRNT) Annual Meeting
- Announced an equity financing totaling up to $124.2 million
that included initial upfront gross proceeds of $60.0 million and
up to an additional approximately $64.2 million of gross proceeds
upon exercise of milestone-driven warrants
“It has been a busy and exciting first quarter of 2024. Our
focus has been to ensure adequate resources and execution of
activities required for the cytisinicline NDA submission in the
United States. We are pleased with the progress we’ve made on
preparations for the ORCA-OL trial, which we expect to initiate in
the coming weeks,” stated John Bencich, Chief Executive Officer of
Achieve. “We are also pleased to once again this quarter have our
trial results presented and published in highly esteemed medical
forums, demonstrating the quality and standard of excellence of our
clinical development program.”
ORCA-V1 Results Published in JAMA
Internal MedicineThe positive Phase 2 ORCA-V1 trial
results for cytisinicline as a treatment for vaping cessation were
published in JAMA IM. Cytisinicline treatment more than doubled the
odds of achieving abstinence and was well tolerated. Achieve
expects to conduct an end-of-Phase 2 meeting with the U.S. Food and
Drug Administration (FDA) in 2024 to discuss future plans for an
expanded label in e-cigarette cessation.
ORCA-OL on Target to Initiate Enrollment in May
2024 Achieve and the FDA reached agreement that a single,
open-label study evaluating for long-term safety exposure of
cytisinicline will be sufficient to enable a New Drug Application
(NDA) submission, now anticipated in the first half of 2025. The
open-label trial, ORCA-OL, is on target to initiate in May 2024 and
will recruit from the over 1,700 participants from earlier trials
to efficiently generate longer-term safety data of cytisinicline
treatment for up to one year.
Clinical Data Presented at Annual Society for Research
on Nicotine and Tobacco ConferenceAchieve presented three
cytisinicline clinical data abstracts during the Annual SRNT
conference. These included Phase 3 trials ORCA-2 and ORCA-3, and
the Phase 2 trial ORCA-V1. In addition to the trial results, for
the first time, survey results from Phase 3 participants revealed
that 69% of those who received cytisinicline experienced success in
quitting smoking and 22% experienced a significant reduction in
smoking. Participants attributed their success to cytisinicline,
citing reduced cravings and manageable side effects. Almost all
participants expressed willingness to recommend cytisinicline to
others. ORCA-3 confirmed higher quit rates with cytisinicline
compared to placebo, without an increased relapse risk.
Additionally, ORCA-V1 demonstrated cytisinicline's potential for
vaping cessation, with significantly increased quit rates and
minimal side effects among e-cigarette users.
Registered Direct Offering and Concurrent Private
PlacementIn February 2024, Achieve entered into a
securities purchase agreement with new and existing investors to
raise up to approximately $124.2 million in gross proceeds that
included initial upfront funding of $60.0 million and up to an
additional approximately $64.2 million upon exercise of
milestone-driven warrants. The proceeds support the ongoing
clinical development of cytisinicline through NDA submission,
including the ORCA-OL trial, to fund other cytisinicline-related
research and clinical development activities and for working
capital and general corporate purposes. Achieve expects proceeds
from the registered direct offering and concurrent private
placement, assuming the exercise of all of the milestone-driven
warrants, plus existing cash, will be sufficient to fund its
development of cytisinicline into 2026 and through potential FDA
approval.
Financial ResultsAs of March 31, 2024,
Achieve’s cash, cash equivalents, and restricted cash totaled $66.4
million, reflecting the closing of the registered direct offering
and concurrent private placement, which resulted in gross proceeds
of $60.0 million prior to deducting placement agent fees and
offering expenses. Total operating expenses for the first quarter
ended March 31, 2024 were $6.0 million. The total net loss for the
first quarter ended March 31, 2024 was $6.5 million. As of May 9,
2024, Achieve had 34,341,303 shares outstanding.
Conference Call DetailsAchieve will host a
conference call at 4:30 PM EDT today, Thursday, May 9, 2024. To
access the webcast, log on to the investor relations page of the
Achieve website and use the following link: 1Q24 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 13744142. 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.1 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 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 of macroeconomic
and geopolitical environment, including inflation, increased
volatility in interest rates and the debt and equity markets,
instability in the global banking system, global health crises and
pandemics and geopolitical conflict 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 March 31, |
|
2024 |
|
2023 |
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
Research and development |
|
2,799 |
|
|
|
5,534 |
|
General and administrative |
|
3,183 |
|
|
|
3,044 |
|
Total operating expenses |
|
5,982 |
|
|
|
8,578 |
|
Loss from
operations |
|
(5,982 |
) |
|
|
(8,578 |
) |
Other income (expense) |
|
(512 |
) |
|
|
(414 |
) |
Net
loss |
$ |
(6,494 |
) |
|
$ |
(8,992 |
) |
|
|
|
|
Basic and
diluted net loss per share |
$ |
(0.26 |
) |
|
$ |
(0.50 |
) |
|
|
|
|
Weighted
average number of basic and diluted common shares |
|
25,048,134 |
|
|
|
17,917,769 |
|
|
|
|
|
|
|
|
|
Consolidated
Balance Sheets |
(In
thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
2024 |
|
2023 |
|
|
|
|
Assets: |
|
|
|
Cash and cash equivalents |
$ |
66,398 |
|
|
$ |
15,546 |
|
Prepaid expenses and other current assets |
|
1,311 |
|
|
|
1,436 |
|
Other assets and restricted cash |
|
94 |
|
|
|
92 |
|
Right-of-use assets |
|
51 |
|
|
|
66 |
|
License agreement |
|
1,141 |
|
|
|
1,197 |
|
Goodwill |
|
1,034 |
|
|
|
1,034 |
|
Total
assets |
$ |
70,029 |
|
|
$ |
19,371 |
|
|
|
|
|
Liabilities
and stockholders' equity: |
|
|
|
Accounts payable and accrued liabilities |
$ |
3,379 |
|
|
$ |
4,088 |
|
Current portion of long-term obligations |
|
53 |
|
|
|
63 |
|
Convertible debt |
|
17,141 |
|
|
|
16,662 |
|
Long-term obligations |
|
— |
|
|
|
6 |
|
Stockholders' equity |
|
49,456 |
|
|
|
(1,448 |
) |
Total
liabilities and stockholders' equity |
$ |
70,029 |
|
|
$ |
19,371 |
|
|
|
|
|
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