Abeona Therapeutics Announces Closing of $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
07 July 2023 - 10:30PM
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the closing of
its previously announced registered direct offering for total gross
proceeds of $25 million, before deducting the placement agents’
fees and other offering expenses.
“Our existing institutional investors have shown
their confidence in Abeona by participating in this registered
direct offering without discounts or warrant coverage,” said Vish
Seshadri, Chief Executive Officer of Abeona. “We have been very
encouraged by the favorable feedback and insights from healthcare
professionals, patient communities, payors and hospital
administrators based on the results of EB-101 in clinical trials,
and we are positioned to launch EB-101 in the U.S. without
depending on a partner. The $25 million offering allows us to now
start preparing for the commercialization of EB-101 and aim for a
timely launch upon potential BLA approval in the first half of
2024, while also extending our cash runway well into the fourth
quarter of 2024.”
Abeona will use the net proceeds from the
offering primarily to fund preparations for commercialization of
its product candidate EB-101, as well as for working capital and
general corporate purposes. Based on EB-101’s Rare Pediatric
Disease designation, Abeona expects to qualify to receive a
priority review voucher (PRV) upon Biologics License Application
(BLA) approval and subject to final determination by the FDA. The
PRV can be used to receive an expedited review process of a
subsequent marketing application for a different product or sold to
another company to create additional capital.
The Company sold 3,284,407 shares of its common
stock (and, in lieu of common stock for certain investors,
pre-funded warrants to purchase 2,919,140 shares of its common
stock) at an offering price of $4.03 per share (or $4.0299 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). The pre-funded warrants are immediately
exercisable at a nominal exercise price of $0.0001 per share and
may be exercised at any time until the pre-funded warrants are
exercised in full.
The offering was led by Nantahala Capital
Management, LLC and included participation by Adage Capital
Partners LP and two other existing investors.
Cantor Fitzgerald & Co. acted as the sole
lead-placement agent for the offering. A.G.P./Alliance Global
Partners acted as the co-placement agent for the offering.
The securities described above were offered
pursuant to a shelf registration statement on Form S-3 (File No.
333-256850) that was filed with the Securities and Exchange
Commission (the “SEC”) on June 7, 2021 and amended on August 27,
2021 and October 19, 2021, and was declared effective by the SEC on
October 22, 2021. The prospectus supplement and the accompanying
prospectus that form a part of the registration statement have been
filed with the SEC and are available on the SEC’s website at
www.sec.gov. Copies of the prospectus supplement and the
accompanying prospectus may also be obtained by contacting Cantor
Fitzgerald & Co., Attention: Equity Capital Markets, 499 Park
Avenue, 4th Floor, New York, NY 10022, or by e-mail at
prospectus@cantor.com.
The securities described above have not been
qualified under any state blue sky laws. This press release does
not constitute an offer to sell or the solicitation of offers to
buy any securities of Abeona being offered, and shall not
constitute an offer, solicitation or sale of any security in any
state or jurisdiction in which such offer, solicitation or sale
would be unlawful prior to registration or qualification under the
securities laws of any such state or jurisdiction.
About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical
company developing cell and gene therapies for serious diseases.
Abeona’s lead clinical program is EB-101, its investigational
autologous, engineered cell therapy currently in development for
recessive dystrophic epidermolysis bullosa. The Company’s
development portfolio also features AAV-based gene therapies for
ophthalmic diseases with high unmet medical need. Abeona’s novel,
next-generation AAV capsids are being evaluated to improve tropism
profiles for a variety of devastating diseases. Abeona’s fully
integrated cell and gene therapy cGMP manufacturing facility
produces EB-101 for the pivotal Phase 3 VIITAL™ study and is
capable of clinical and potential commercial production of
AAV-based gene therapies.
Forward-Looking Statements This
press release contains certain statements that are forward-looking
within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended, and that involve risks and uncertainties. We have
attempted to identify forward-looking statements by such
terminology as “may,” “will,” “believe,” “anticipate,” “expect,”
“intend,” and similar expressions (as well as other words or
expressions referencing future events, conditions or
circumstances), which constitute and are intended to identify
forward-looking statements. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, numerous risks and uncertainties,
including but not limited to, the timing and outcome of our
Biologics License Application submission to the FDA for EB-101;
continued interest in our rare disease portfolio; our ability to
enroll patients in clinical trials; the outcome of future meetings
with the FDA or other regulatory agencies, including those relating
to preclinical programs; the ability to achieve or obtain necessary
regulatory approvals; the impact of any changes in the financial
markets and global economic conditions; risks associated with data
analysis and reporting; and other risks disclosed in the Company’s
most recent Annual Report on Form 10-K and subsequent periodic
reports filed with the Securities and Exchange Commission. The
Company undertakes no obligation to revise the forward-looking
statements or to update them to reflect events or circumstances
occurring after the date of this press release, whether as a result
of new information, future developments or otherwise, except as
required by the federal securities laws.
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
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