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 that it has entered into a
securities purchase agreement with new and existing investors to
raise up to approximately $124.2 million in gross proceeds that
includes initial upfront funding of $60.0 million and up to an
additional approximately $64.2 million upon exercise of
milestone-driven warrants.
The financing includes participation from healthcare-dedicated
investors, including Propel Bio Partners LLC, Nantahala Capital,
and a large, life sciences-dedicated investor. The financing also
includes participation from strategic investor Sopharma and certain
members of the company’s management team and board of
directors.
Lake Street Capital Markets, LLC and JonesTrading Institutional
Services LLC are acting as joint placement agents for the
registered direct offering and concurrent private placement.
The purchase and sale will be completed, in part, via a
registered direct offering of 13,086,151 shares of common stock at
a price of $4.585 per share. In a concurrent private placement, the
company will issue unregistered warrants to purchase up to
13,086,151 shares of common stock at an exercise price of $4.906
per share (provided, however, that the purchaser may elect to
exercise the warrants for pre-funded warrants in lieu of shares of
common stock at an exercise price of $4.906, minus $0.001, the
exercise price of each pre-funded warrant). These warrants will be
immediately exercisable for shares of common stock or pre-funded
warrants in lieu thereof, and will expire on the earlier of (i)
three and one-half years following the date of issuance and (ii) 30
days following Achieve’s public disclosure of the acceptance of a
New Drug Application (NDA) for cytisinicline by the U.S. Food and
Drug Administration (FDA) in a Day 74 Letter or equivalent
correspondence.
The registered direct offering and the concurrent private
placement are each expected to close on or about March 4, 2024,
subject to customary closing conditions. The aggregate gross
proceeds from the issuance of common stock in the registered direct
offering are expected to be approximately $60.0 million, prior to
deducting placement agent fees and estimated offering expenses. The
company intends to use the proceeds from the offering to fund
clinical development of cytisinicline through NDA submission,
expected in 1H 2025, including the ORCA-OL clinical trial, to fund
other cytisinicline related research and clinical development
activities and for working capital and general corporate purposes.
If the milestone-driven warrants issued in the private placement
are exercised in full, the company would receive $64.2 million in
additional proceeds. The company expects that the net 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.
The shares of common stock are being offered pursuant to a shelf
registration statement on Form S-3 (File No. 333-261811), which was
declared effective by the United States Securities and Exchange
Commission (“SEC”) on January 5, 2022.
The milestone-driven warrants being issued in the private
placement, along with the securities underlying such
milestone-driven warrants, are being offered in a private placement
under Section 4(a)(2) of the Securities Act of 1933, as amended
(the “Securities Act”), and/or Regulation D promulgated thereunder
and have not been registered under the Securities Act, or
applicable state securities laws. Accordingly, the milestone-driven
warrants and underlying 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 and such applicable state
securities laws.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy any securities of Achieve, 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 registration or qualification under the
securities laws of such state or jurisdiction. A prospectus
supplement relating to the registered shares of common stock will
be filed by the company with the SEC. When available, copies of the
prospectus supplement, together with the accompanying prospectus,
can be obtained at the SEC’s website at www.sec.gov or from Lake
Street Capital Markets, LLC, Prospectus Department, 920 Second
Avenue South, Suite 700, Minneapolis, Minnesota 55402 or by email
at info@lakestreetcm.com or JonesTrading Institutional Services
LLC, Attention: Equity Capital Markets, 325 Hudson Street, 6th
Floor New York, New York 10013;
email: ecm@jonestrading.com.
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.
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
completion of the offering, the expected net proceeds of the
offering, the expected net proceeds upon exercise of the warrants,
the intended use of the proceeds of the offering and the expected
sufficiency of such proceeds to fund the development of
cytisinicline through potential FDA approval. 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, risks regarding Achieve’s ability to satisfy closing
conditions related to the offering; risks related to market
conditions; 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 Achieve’s 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
law.
Investor Relations Contact Nicole
Jonesachv@cg.capital(404) 736-3838
Media Contact Glenn
Silver Glenn.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.
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