IRVINE, Calif.--(BUSINESS WIRE)--Sep. 4, 2018--
Novus Therapeutics, Inc. (NASDAQ: NVUS), a specialty pharmaceutical
company focused on developing products for patients with disorders of
the ear, nose, and throat (“ENT”), today announced that it has commenced
an underwritten public offering of 6,000,000 shares of its common stock.
Novus expects to grant the underwriters of the offering an option for a
period of 30 days to purchase up to an additional 900,000 shares of
common stock. The offering is subject to market and other conditions,
and there can be no assurance as to whether or when the offering may be
completed.
Novus intends to use the net proceeds of the offering to fund two phase
2 clinical trials, including one study to evaluate OP-02 as a treatment
for otitis media with effusion (“OME”) and as a treatment to prevent
chronic otitis media with effusion (“COME”) in children, and a second
study to evaluate OP-02 as a treatment to prevent recurrent acute otitis
media (“RAOM”) in children.
Piper Jaffray & Co. is acting as the sole book-running manager for the
offering. Ladenburg Thalmann & Co. Inc. and LifeSci Capital LLC are
acting as co-managers for the offering.
A registration statement relating to these securities has been filed on
Form S-1 with the Securities and Exchange Commission (“SEC”) but has not
yet become effective. These securities may not be sold, nor may offers
to buy be accepted, prior to the time the registration statement becomes
effective. This offering is being made solely by means of a prospectus
and will be available on the SEC's website located at http://www.sec.gov.
Copies of the preliminary prospectus may also be obtained by request
from Piper Jaffray & Co., 800 Nicollet Mall, J12503, Minneapolis, MN
55402, Attention: Prospectus Department or by e-mail at prospectus@pjc.com
or by phone at (800) 747-3924.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy, 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 any such state or
jurisdiction.
About OP-02
OP-02 is being developed as a potential first-in-class treatment option
for otitis media (“OM”), which is often caused by Eustachian tube
dysfunction (“ETD”). OP-02 is a drug-device combination product
comprised of a proprietary formulation surfactant
(dipalmitoylphosphatidylcholine or “DPPC”) and a spreading agent
(cholesteryl palmitate or “CP”) suspended in propellant. The product is
administered intranasally via a pressurized metered- dose inhaler
(“pMDI”) and is intended to be used to restore the normal physiologic
activity of the Eustachian tube (“ET”), which is the small tube that
connects the middle ear to the back of the nasopharynx. Together DPPC
and CP are designed to effectively absorb to the air-liquid interface of
the mucosa and reduce the interfacial surface tension of the ET, which
reduces passive pressure required for the ET to open. In other words,
OP-02 is intended to promote ‘de-sticking’ of the ET so that ventilation
and drainage of the middle ear may occur.
About Novus Therapeutics
Novus Therapeutics, Inc. (“Novus”) is a specialty pharmaceutical company
focused on developing products for patients with disorders of the ear,
nose, and throat (“ENT”). Novus has two technologies, each that has the
potential to be developed for multiple ENT indications. Novus’ lead
product candidate (OP-02) is a surfactant-based, combination drug
product being developed as a potential first-in-class treatment option
for patients at risk for, or with, otitis media (“OM” or middle ear
inflammation with or without infection). Globally, OM affects more than
700 million adults and children every year, with over half of cases
occurring in children under five years of age. OM is one of the most
common disorders seen in pediatric practice, and in the United States is
a leading cause of health care visits and the most frequent reason
children are prescribed antibiotics or undergo surgery. Novus also has a
foam-based drug delivery technology (OP-01), which may be developed in
the future to deliver drugs into the ear, nasal, and sinus cavities.
Forward-Looking Statements
Any statements in this press release about the company’s future
expectations, plans and prospects, including statements about its
strategy, future operations, development of its product candidates, the
review of strategic alternatives and the outcome of such review and
other statements containing the words “believes,” “anticipates,”
“plans,” “expects,” “may,” and similar expressions, constitute
forward-looking statements within the meaning of The Private Securities
Litigation Reform Act of 1995. Forward-looking statements include, but
are not limited to, expectations regarding the timing for the
commencement and completion of our clinical trials, manufacture drug
product and our ability to accelerate the development of our drug
candidates. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: the sufficiency of the company’s cash resources; the
ability to timely develop and manufacture clinical batches of our study
drugs; the ability to obtain necessary approvals to commence additional
clinical trials; whether data from early clinical trials will be
indicative of the data that will be obtained from future clinical
trials; whether the results of clinical trials will warrant submission
for regulatory approval of any investigational product, any such
submission will receive approval from the United States Food and Drug
Administration or equivalent foreign regulatory agencies and, if we are
able to obtain such approval for an investigational product, it will be
successfully distributed and marketed. Any forward-looking statements
contained in this press release speak only as of the date hereof and not
of any future date, and the company expressly disclaims any intent to
update any forward-looking statements, whether as a result of new
information, future events or otherwise. For a further description of
the risks and uncertainties that could cause actual results to differ
from those expressed in these forward-looking statements, as well as
risks relating to the business of the Company in general, see Novus’s
Registration Statement on Form S-1 filed with the Securities and
Exchange Commission on August 1, 2018, as amended from time to time, its
Quarterly Report on Form 10-Q for the quarter ended June 31, 2018 filed
with the Securities and Exchange Commission on August 7, 2018, and its
subsequent periodic reports filed with the Securities and Exchange
Commission.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180904005838/en/
Source: Novus Therapeutics, Inc.
Investor Contacts
LifeSci Advisors, LLC
Timothy
McCarthy, 212-915-2564
tim@lifesciadvisors.com
