CUPERTINO, Calif., July 20,
2023 /PRNewswire/ -- DURECT Corporation (Nasdaq:
DRRX) ("DURECT"), a biopharmaceutical company focused on developing
its epigenetic regulator program for the treatment of acute organ
injury and chronic liver diseases, today announced that it has
entered into definitive agreements for the purchase and sale of an
aggregate of 2,991,027 shares of common stock and accompanying
warrants to purchase up to 2,991,027 shares of common stock in a
registered direct offering (the "Offering") priced at-the-market
under Nasdaq rules. The shares of common stock and accompanying
warrants are being sold at a combined purchase price of
$5.015 per share and accompanying
warrant. The warrants will have an exercise price of
$4.89 per share, will be immediately
exercisable and will expire five years from the date of
issuance.
The closing of the Offering is expected to occur on or about
July 21, 2023, subject to customary
closing conditions. The gross proceeds from the Offering are
expected to be approximately $15
million, before deducting fees to the placement agents and
other estimated offering expenses payable by DURECT. DURECT
intends to use the net proceeds of the Offering for general
corporate purposes, which may include clinical trials, research and
development activities, capital expenditures, selling, general and
administrative costs, facilities expansion, and to meet working
capital needs.
H.C. Wainwright & Co. is acting as exclusive placement agent
for the Offering.
The Offering is being made pursuant to a "shelf" registration
statement on Form S-3 (File No. 333-258333) previously filed by
DURECT with the Securities and Exchange Commission (the "SEC") on
July 30, 2021 and declared effective
by the SEC on August 16, 2021. The
Offering is being made only by means of a prospectus, including a
prospectus supplement, forming a part of the effective registration
statement. The prospectus supplement and the accompanying
prospectus relating to, and describing the terms of, the Offering
will be filed with the SEC. You may get these documents for free by
visiting EDGAR on the SEC website at www.sec.gov. Alternatively,
copies of the prospectus supplement and accompanying prospectus can
be obtained, when available, from H.C. Wainwright & Co., LLC at
430 Park Avenue, 3rd Floor, New York,
NY 10022, by phone at (212) 856-5711 or e-mail at
placements@hcwco.com.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any state or other jurisdiction
in which such offer, solicitation or sale would be unlawful prior
to the registration or qualification under the securities laws of
any such state or other jurisdiction.
About DURECT Corporation
DURECT is a biopharmaceutical company committed to transforming
the treatment of acute organ injury and chronic liver diseases by
advancing novel and potentially lifesaving therapies based on its
endogenous epigenetic regulator program. Larsucosterol (also known
as DUR-928), DURECT's lead drug candidate, binds to and inhibits
the activity of DNA methyltransferases (DNMTs), epigenetic enzymes
which are elevated and associated with hypermethylation found in
alcohol-associated hepatitis (AH) patients. Larsucosterol is in
clinical development for the potential treatment of AH, for which
FDA has granted a Fast Track Designation; non-alcoholic
steatohepatitis (NASH) is also being explored. In addition,
POSIMIR® (bupivacaine solution) for infiltration use, a
non-opioid analgesic utilizing the innovative
SABER® platform technology, is FDA-approved and has
been exclusively licensed to Innocoll Pharmaceuticals for
development and commercialization in the
United States.
Forward-Looking Statements
This press release contains forward-looking statements,
including statements made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995, relating to:
the Offering, statements regarding the completion of the Offering
and the expected use of proceeds from the Offering, our plan to
report topline data in the fourth quarter of 2023, the potential
FDA approval of larsucosterol for the treatment of AH, the ability
of a positive outcome in the AHFIRM trial to support a New Drug
Application (NDA) filing and our ability to expedite the NDA
process using the Fast Track Designation granted by the FDA,
larsucosterol's potential to be the first FDA-approved therapy for
AH, our plans to commercialize larsucosterol if approved, the
potential to develop larsucosterol for AH or other indications, and
the potential benefits, if any, of our product candidates. Actual
results may differ materially from those contained in the
forward-looking statements contained in this press release, and
reported results should not be considered as an indication of
future performance. The potential risks and uncertainties that
could cause actual results to differ from those projected include,
among other things, failure to satisfy closing conditions relating
to the Offering, stock price volatility and risks and uncertainties
related to market conditions, the risk that ongoing and future
clinical trials of larsucosterol do not confirm the results from
earlier clinical or pre-clinical trials, or do not demonstrate the
safety or efficacy of larsucosterol in a statistically significant
manner, the risk that the FDA or other government agencies may
require additional clinical trials for larsucosterol before
approving it for the treatment of AH even if the results of the
AHFIRM trial are successful, and risks related to the sufficiency
of our cash resources, our anticipated capital requirements, our
need or desire for additional financing, our ability to obtain
capital to fund our operations and expenses and our ability to
continue to operate as a going concern. Further information
regarding these and other risks is included in DURECT's most recent
SEC filings, including its annual report on Form 10-K for the year
ended December 31, 2022 and quarterly
report on Form 10-Q for the quarter ended March 31, 2023 under the heading "Risk Factors."
These reports are available on our website www.durect.com under the
"Investors" tab and on the SEC's website at www.sec.gov. All
information provided in this press release and in the attachments
is based on information available to DURECT as of the date hereof,
and DURECT assumes no obligation to update this information as a
result of future events or developments, except as required by
law.
NOTE: Larsucosterol (DUR-928) is an investigational drug
candidate under development and has not been approved for
commercialization by the U.S. Food and Drug Administration or other
health authorities for any indication.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/durect-corporation-announces-15-million-registered-direct-offering-priced-at-the-market-under-nasdaq-rules-301881818.html
SOURCE DURECT Corporation