Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN)
(“Diffusion” or the “Company”), a clinical-stage biotechnology
company developing new treatments for life-threatening medical
conditions by improving the body’s ability to bring oxygen to the
areas where it is needed most, today announced that it has priced a
public offering of an aggregate of 11,428,572 shares of common
stock (or common stock equivalents) of the Company, together with
accompanying common warrants, at a public offering price of $0.35
per share and associated warrants. Each share of common stock
(or common stock equivalent) sold in the offering was sold
collectively with (i) a common warrant to purchase one share of
common stock expiring eighteen months from the date of issuance and
(ii) a common warrant to purchase one share of common stock
expiring five years from the date of issuance. Each common warrant
has an exercise price of $0.35.
H.C. Wainwright & Co. is acting as the
exclusive placement agent for the offering.
The gross proceeds to Diffusion from this
offering are expected to be $4.0 million, before deducting the
placement agent’s fees and other estimated offering expenses
payable by Diffusion, assuming none of the warrants issued in this
offering are exercised. The offering is expected to close on or
about November 15, 2019, subject to the satisfaction of customary
closing conditions.
Diffusion anticipates using the net proceeds
from the offering to fund research and development of its lead
product candidate, transcrocetinate sodium, also known as trans
sodium crocetinate (TSC), including clinical trial activities, and
for general corporate purposes.
The securities described above are being offered
by the Company pursuant to a registration statement (File No.
333-234234) previously filed with and declared effective by the
Securities and Exchange Commission (the “SEC”) on November 13,
2019. A preliminary prospectus relating to the securities
being offered was filed with the SEC on November 12, 2019 and is
available on the SEC’s website at http://www.sec.gov. Electronic
copies of the final prospectus relating to the 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.
This announcement is neither an offer to
sell, nor a solicitation of an offer to buy, any of these
securities and shall not constitute an offer, solicitation or sale
in any state or jurisdiction in which such offer, solicitation or
sale is unlawful. Any offer, if at all, will be made only by
means of the prospectus forming a part of the effective
registration statement.
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.
Its on-ambulance PHAST-TSC acute stroke protocol
has begun patient enrollment. 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
brain cancer. 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 closing
of this offering; the use of proceeds of this offering; 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.
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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