Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN)
(“Diffusion,” the “Company,” “we,” “our” or “us”) today announced
the closing of its previously announced registered direct offering,
priced at-the-market, with certain institutional investors of
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 issued 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 are
exercisable upon issuance and will expire five and one half years
following the date of issuance.
H.C. Wainwright & Co. acted as the exclusive
placement agent in connection with the offering.
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) were 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 were filed with the SEC. Copies of the prospectus
supplement and the accompanying prospectus relating to the
registered direct offering may be obtained 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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