SAN
DIEGO, Aug. 9, 2022 /PRNewswire/ -- Heron
Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology
company focused on improving the lives of patients by developing
and commercializing therapeutic innovations that improve medical
care, announced today that it has entered into a securities
purchase agreement to sell in a private placement to a group of new
and existing institutional investors, led by Deep Track Capital, LP
and including participation from Great Point Partners, Broadfin
Holdings, LLC and other leading healthcare investors, 16,129,032
shares of its common stock at an offering price of $3.10 per share, and, to certain investors in
lieu of common stock, pre-funded warrants to purchase up to
8,548,387 shares of common stock at a purchase price of
$3.0999 per pre-funded warrant, which
represents the per share offering price for the common stock less
the $0.0001 per share exercise price
for each pre-funded warrant. Gross proceeds of the private
placement are expected to be approximately $76.5 million, before deducting placement agent
fees and other expenses. The private placement is expected to close
on or about August 11, 2022, subject
to the satisfaction of customary closing conditions.
Heron intends to use the net proceeds from the proposed private
placement to support its acute care and oncology care commercial
franchises, including accelerating the adoption of
ZYNRELEF® and preparing for the anticipated launch
of HTX-019 for the prevention of postoperative nausea and vomiting
("PONV") ahead of the September PDUFA date, and for working capital
and general corporate purposes.
Cantor Fitzgerald & Co. is acting as sole placement
agent.
The securities being issued and sold in the private placement
have not been registered under the Securities Act of 1933, as
amended (the "Securities Act"), or any states' securities laws and
may not be offered or sold in the United States, except pursuant to an effective
registration statement or an applicable exemption from the
registration requirements of the Securities Act. Heron has agreed
to file a registration statement with the Securities and
Exchange Commission (the "SEC") registering the resale of the
shares of common stock issued in this private placement (the
"Resale Shares").
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 the
securities being offered 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 jurisdiction. Any offering of the Resale Shares under
the resale registration statement will only be by means of a
prospectus.
About Heron Therapeutics,
Inc.
Heron Therapeutics, Inc. is a commercial-stage
biotechnology company focused on improving the lives of patients by
developing and commercializing therapeutic innovations that improve
medical care. Our advanced science, patented technologies, and
innovative approach to drug discovery and development have
allowed us to create and commercialize a portfolio of products that
aim to advance the standard-of-care for acute care and oncology
patients.
About ZYNRELEF for Postoperative
Pain
ZYNRELEF is the first and only dual-acting local anesthetic that
delivers a fixed-dose combination of the local anesthetic
bupivacaine and a low dose of nonsteroidal anti-inflammatory drug
meloxicam. ZYNRELEF is the first and only extended-release local
anesthetic to demonstrate in Phase 3 studies significantly reduced
pain and significantly increased proportion of patients requiring
no opioids through the first 72 hours following surgery
compared to bupivacaine solution, the current standard-of-care
local anesthetic for postoperative pain control. ZYNRELEF was
initially approved by the FDA in May 2021 for use in
adults for soft tissue or periarticular instillation to produce
postsurgical analgesia for up to 72 hours after bunionectomy, open
inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of
ZYNRELEF's indication. ZYNRELEF is now indicated in the U.S. in
adults for soft tissue or periarticular instillation to produce
postsurgical analgesia for up to 72 hours after foot and ankle,
small-to-medium open abdominal, and lower extremity total joint
arthroplasty surgical procedures. Safety and efficacy have not been
established in highly vascular surgeries, such as intrathoracic,
large multilevel spinal, and head and neck procedures.
In September 2020, the European Commission granted a
marketing authorization for ZYNRELEF for the treatment of somatic
postoperative pain from small- to medium-sized surgical wounds in
adults. As of January 1, 2021, ZYNRELEF is approved in 31
European countries including the countries of the European
Union and European Economic Area and the United Kingdom.
In March 2022, Health Canada issued a
Notice of Compliance for ZYNRELEF for instillation into the
surgical wound for postoperative analgesia after bunionectomy, open
inguinal herniorrhaphy, and total knee arthroplasty surgical
procedures.
Please see full prescribing information, including Boxed
Warning, at www.ZYNRELEF.com.
About HTX-019 for
PONV
HTX-019 is an IV injectable emulsion formulation designed to
directly deliver aprepitant, the active ingredient in
EMEND® (aprepitant) capsules, which is the only
substance P/neurokinin-1 (NK1) receptor antagonist (RA)
to be approved in the United States for the prevention of
PONV in adults. The FDA-approved dose of oral EMEND is 40 mg
for PONV prevention, which is given within 3 hours prior to
induction of anesthesia for surgery. In a Phase 1 clinical
trial, 32 mg of HTX-019 as a 30-second IV injection was
demonstrated to be bioequivalent to oral aprepitant 40 mg. The NDA
for HTX-019 for PONV was submitted in November 2021 and the FDA set a PDUFA goal date
of September 17, 2022.
Forward-looking
Statements
This news release contains "forward-looking statements" as
defined by the Private Securities Litigation Reform Act of 1995.
All statements, other than statements of historical facts included
in this press release, including, but not limited to, Heron's
expectations regarding the completion of the private placement, the
satisfaction of customary closing conditions related to the private
placement and the expected receipt and intended uses of the
proceeds from the private placement, are forward-looking
statements. Heron cautions readers that forward-looking statements
are based on management's expectations and assumptions as of the
date of this news release and are subject to certain risks and
uncertainties that could cause actual results to differ materially,
including, but not limited to, uncertainties related to market
conditions and the completion of the private placement on the
anticipated terms or at all, the uncertainties inherent in the
clinical drug development process; the timing of regulatory
filings; the potential market opportunities for ZYNRELEF in
the United States, Europe and Canada; the timing of the NDA review process
for HTX-019 and whether the FDA approves HTX-019; the potential
market opportunity for HTX-019; the expected future balances of
Heron's cash, cash equivalents and short-term investments; the
expected duration over which Heron's cash, cash equivalents and
short-term investments balances will fund its operations; the
extent of the impact of the ongoing COVID-19 pandemic on our
business; and other risks and uncertainties described in "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in Heron's Annual Report on
Form 10-K for the year ended December 31,
2021, filed with the SEC on February
28, 2022, and other subsequent documents we file with the
SEC, including but not limited to our Quarterly Reports on Form
10-Q. Forward-looking statements reflect our analysis only on their
stated date, and Heron takes no obligation to update or revise
these statements except as may be required by law.
Investor Relations and Media Contact:
David Szekeres
Executive Vice President, Chief Operating Officer
Heron Therapeutics, Inc.
dszekeres@herontx.com
858-251-4447
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SOURCE Heron Therapeutics, Inc.