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 that it has entered into
definitive agreements 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.
The private placement will be for up to 4,093,141 units at a
price of $4.625 per unit, with each unit consisting of two shares
of common stock and one warrant to purchase one share of common
stock. The private placement was priced at $2.3125 per common
share, an 8.6% premium to the closing price of the Company’s common
stock the day prior to entering into the subscription agreements,
including a one-half warrant per share. The private placement is
expected to close on or about November 18, 2022, subject to
customary closing conditions. The warrants will have an initial per
share exercise price of $4.50. All warrants will be exercisable
beginning on the six-month anniversary of the closing of the
offering and will have a seven-year term. The Company intends to
use the proceeds from the private placement to fund clinical
research and development, and for general working capital. It
estimates that the net proceeds, plus its existing financial
resources, are sufficient to fund operations into late 2023.
The private placement includes a new life sciences focused
investment fund, participation from Achieve management, as well as
new and existing investors. Lake Street Capital Markets, LLC is
acting as the exclusive placement agent in connection with this
offering.
The securities being issued and sold in the private placement
have not been registered under the Securities Act of 1933, as
amended (the “Securities Act”), or any state’s securities laws, and
are being issued and sold in reliance on Section 4(a)(2) of the
Securities Act and Regulation D promulgated thereunder. The
securities may not be offered or sold in the United States, except
pursuant to an effective registration statement or an applicable
exemption from the registration requirements of the Securities Act.
Achieve has agreed to file a registration statement to register the
resale of the shares of common stock included in the units and
underlying the warrants within 60 days of the closing of the
offering. This press release shall not constitute an offer to sell
or the solicitation of an offer to buy any securities described
herein, nor shall there be any sale of these securities in any
state or jurisdiction in which such offer, solicitation or sale
would be unlawful prior to the registration or qualification under
the securities laws of any such state or jurisdiction.
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.2
In 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
closing of the private placement, registration of the shares of
common stock being issued and sold in the private placement,
including those shares underlying the warrants, Achieve’s use of
the proceeds from the private placement, expectations regarding
Achieve’s cash forecasts, 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
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, 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.mm6946a44Ogunwale, 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.
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