In a release issued under the same headline earlier today
by Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN), please note
that the pricing and figures in the first paragraph of the release
have changed. The corrected release follows:
Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN).
(“Diffusion,” the “Company,” “we,” “our” or “us”) today announced
that it has entered into definitive securities purchase agreements
with certain institutional investors to purchase in a registered
direct offering priced at-the-market 6,266,787 shares of the
Company’s common stock, at a purchase price of $0.5585 per share
and associated warrant. The Company also agreed to issue to the
institutional investors in a concurrent private placement
unregistered warrants to purchase up to 6,266,787 shares of common
stock, at an exercise price of $0.4335 per share. The gross
proceeds to Diffusion, before deducting placement agent fees and
other offering expenses, are expected to be approximately $3.5
million. The warrants will be exercisable upon issuance and will
expire five and one-half years following the date of issuance. The
closing of the sale of the securities is expected to occur on or
about December 13, 2019, subject to the satisfaction of customary
closing conditions.
H.C. Wainwright & Co. is acting as the
exclusive placement agent for the offerings.
Diffusion currently intends to use the net
proceeds from the offering, together with approximately $3.5
million the Company received from exercise of warrants since
November 15, 2019, to fund research and development of its lead
product candidate, TSC, including clinical trial activities, and
for general corporate purposes. Diffusion believes its cash and
cash equivalents as of the date hereof, including the receipt of
proceeds from the offerings, are sufficient to fund operations for
at least the next 12 months.
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.
Electronic 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, New York 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 is the target for
TSC’s novel mechanism.
In July 2019 the Company reported favorable
safety data in a 19-patient dose-escalation run-in study to its
Phase 3 INTACT program, using TSC to target inoperable GBM. Further
findings from the dose-escalation run-in study, released in
December 2019, also showed signals of enhanced survival and patient
performance. Diffusion’s on-ambulance PHAST-TSC trial for acute
stroke has begun patient enrollment. In addition, preclinical data
supports the potential for 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.
Further, 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 regarding the registered direct offering, the
intended use of proceeds and the timing of the closing of the
offering, as well as 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: Diffusion’s ability to maintain its Nasdaq listing, the
use of proceeds of the offering, market conditions, 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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