IRVINE, Calif.--(BUSINESS WIRE)--Sep. 7, 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 elected
to postpone the previously announced public offering of its common stock
due to market conditions, including valuation sensitivity at the current
share price.
As of June 30, 2018, the company had $19.2 million in cash and cash
equivalents. Novus believes that its current cash will be sufficient to
achieve several key milestones in 2019, including completion of its
planned phase 1 clinical trials with OP-02 in healthy adults, children
with otitis media with effusion (“OME”), and adults with acute otitis
media (“AOM”).
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 and
any capital raising plans or activities; 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 annual 10-K, quarterly 10-Q, and
additional filings with the Securities and Exchange Commission at www.sec.gov/.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180907005240/en/
Source: Novus Therapeutics, Inc.
LifeSci Advisors, LLC
Timothy McCarthy, 212-915-2564
tim@lifesciadvisors.com
