Abeona Therapeutics Announces $25 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
03 Julio 2023 - 7:45AM
Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has
raised $25 million at-the-market from select existing investors,
primarily to fund initiation of the Company’s launch preparations
in anticipation of the EB-101 Biologics License Application (BLA)
submission and potential approval.
The company has entered into definitive
agreements with certain existing institutional investors for the
issuance and sale of 3,284,407 shares of its common stock, and in
lieu of common stock, 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 will be 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 closing of the
offering is expected to occur on or about July 6, 2023, subject to
the satisfaction of customary closing conditions.
The offering was led by Nantahala Capital
Management, LLC and included participation by Adage Capital
Partners LP and two other existing institutional investors.
Cantor Fitzgerald & Co. is acting as the
sole lead-placement agent for the offering. A.G.P./Alliance Global
Partners is acting as the co-placement agent for the offering.
The gross proceeds to Abeona from this offering
are expected to be approximately $25 million, before deducting the
placement agent’s fees and other offering expenses. Abeona intends
to 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
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 to fund the EB-101 launch.
The securities described above are being 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 offering is being made only by means of the
written prospectus and prospectus supplement that form a part of
the registration statement. 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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