Diffusion Pharmaceuticals Inc. (Nasdaq:
DFFN) (“Diffusion,” the “Company,” “we,” “our” or
“us”) today announced that it has entered into a definitive
securities purchase agreement with certain institutional investors
to purchase in a registered direct offering 1,317,060 shares of the
Company’s common stock, at a price of $4.77 per share, for
aggregate gross proceeds of approximately $6.28 million. The
Company also agreed to issue 1,317,060 unregistered warrants to the
institutional investors in a concurrent private placement to
purchase one share of common stock for each share of common stock
purchased with an exercise price of $5.00 per share for aggregate
gross proceeds of approximately $165 thousand. The warrants will be
exercisable upon issuance and will expire five and a half years
following the date of issuance. The closing of the sale of the
securities is expected to take place on or about May 28, 2019,
subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the
exclusive placement agent in connection with the registered direct
offering and the concurrent private placement.
Diffusion currently intends to use the net
proceeds from the offering to fund research and development of our
lead product candidate, TSC, including clinical trial activities,
and for general corporate purposes.
The shares of common stock (but not the warrants
or the shares of common stock underlying the warrants) are being
offered pursuant to a “shelf” registration statement on Form S-3
(File No. 333-231541), which was declared effective by the
Securities and Exchange Commission (SEC) on May 22, 2019. A
prospectus supplement and the accompanying prospectus relating to
the registered direct offering will be filed with the SEC. Copies
of the prospectus supplement and the accompanying prospectus
relating to the registered direct offering may be obtained, when
available, from H.C. Wainwright & Co., LLC, 430 Park Avenue 3rd
Floor, New York, NY 10022, or by calling (646) 975-6996 or by
emailing placements@hcwco.com or at the SEC’s website at
http://www.sec.gov.
The warrants and shares issuable upon exercise
of the warrants offered in the concurrent private placement have
not been registered under the Securities Act of 1933, as amended,
and may not be offered or sold in the United States absent
registration with the SEC or an applicable exemption from such
registration requirements.
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 jurisdiction in which such
offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
jurisdiction.
About Diffusion Pharmaceuticals
Inc.
Diffusion Pharmaceuticals Inc. is an innovative
biotechnology company developing new treatments that improve the
body’s ability to bring oxygen to the areas where it is needed
most, offering new hope for the treatment of life-threatening
medical conditions.
Diffusion’s lead drug TSC was originally
developed in conjunction with the Office of Naval Research, which
was seeking a way to treat hemorrhagic shock caused by massive
blood loss on the battlefield.
Evolutions in research have led to Diffusion’s
focus today: Fueling Life by taking on some of medicine’s
most intractable and difficult-to-treat diseases, including stroke
and GBM brain cancer. In each of these diseases, hypoxia – oxygen
deprivation of essential tissue in the body – has proved to be a
significant obstacle for medical providers and the target for TSC’s
novel mechanism.
In January 2018 the Company began enrolling
patients in the lead-in phase to its Phase 3 INTACT program, using
TSC to target inoperable GBM brain cancer. In September 2018 its
on-ambulance PHAST-TSC acute stroke protocol was granted FDA
clearance to proceed. Additional preclinical data supports the
potential use of TSC as a treatment for other conditions where
hypoxia plays a major role, such as myocardial infarction,
respiratory diseases such as COPD, peripheral artery disease, and
neurodegenerative conditions such as Alzheimer’s and Parkinson’s
disease.
In addition, RES-529, the Company’s
PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and
mTORC2 complexes, is in preclinical testing for GBM.
Diffusion is headquartered in Charlottesville,
Virginia – a hub of advancement in the life science and
biopharmaceutical industries – and is led by CEO David Kalergis, a
30-year industry veteran and company co-founder.
Forward-Looking Statements
To the extent any statements made in this news
release deal with information that is not historical, these are
forward-looking statements under the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements about the company's plans, objectives,
expectations and intentions with respect to future operations
and products, the potential of the company's technology and product
candidates, the anticipated timing of future clinical trials, and
other statements that are not historical in nature, particularly
those that utilize terminology such as "would," "will," "plans,"
"possibility," "potential," "future," "expects," "anticipates,"
"believes," "intends," "continue," "expects," other words of
similar meaning, derivations of such words and the use of future
dates. Forward-looking statements by their nature address matters
that are, to different degrees, uncertain. Uncertainties and risks
may cause the Diffusion’s actual results to be materially different
than those expressed in or implied by such forward-looking
statements. Particular uncertainties and risks include: the
difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance;
general business and economic conditions; the company's need for
and ability to obtain additional financing or partnering
arrangements; and the various risk factors (many of which are
beyond Diffusion’s control) as described under the heading “Risk
Factors” in Diffusion’s filings with the United States Securities
and Exchange Commission. All forward-looking statements in this
news release speak only as of the date of this news release and are
based on management's current beliefs and expectations. Diffusion
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Investor Contacts:David
Kalergis, CEODiffusion Pharmaceuticals Inc.(434)
220-0718dkalergis@diffusionpharma.com
LHA Investor RelationsKim Sutton Golodetz(212)
838-3777kgolodetz@lhai.com
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