Orchard Therapeutics Announces Second Closing of Strategic Financing, Resulting in $34 Million of Additional Capital
26 Junho 2023 - 8:00AM
Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader,
today announced that it has completed the second closing of its
previously announced securities purchase agreement, resulting in
$34 million of new capital before placement agent and transaction
fees.
In March 2023, the company completed the first closing of an
innovative financing arrangement, led by RA Capital Management with
participation from other leading healthcare investors that resulted
in $34 million of new capital before placement agent and
transaction fees. Per the terms of the agreement, the company could
bring in an aggregate of up to $188 million (inclusive of the $68
million raised at the first and second closings) at increasing
valuations following the achievement of certain U.S. regulatory
milestones for OTL-200 for MLD. The conditions of the second
closing included shareholder approval and the company’s intention
to initiate a biologics license application (BLA) submission
following receipt of minutes from a productive pre-BLA meeting
with the U.S. Food and Drug Administration for OTL-200, both
of which have been achieved. The second closing comprises the sale
of units at a purchase price of $8.00 per unit for aggregate
proceeds of $34 million, including the issuance of 4.25 million
American Depository Shares (ADSs) as well as warrants.
“The initiation of our BLA submission marks a significant
de-risking event for Orchard and our OTL-200 program ahead of a
potential U.S. approval in MLD,” said Frank Thomas, president and
chief operating officer of Orchard Therapeutics. “This next wave of
funding from the second closing is expected to provide important
capital to support preparations for our anticipated first U.S.
launch and advance our next-in-line neurometabolic programs derived
from our HSC gene therapy platform. We want to thank each of the
participating investors for supporting this unique and innovative
structure and partnering with us to develop a standout company in
the field of gene therapy.”
Guggenheim Securities, LLC acted as the sole placement agent for
the private placement.
Orchard intends to use the net proceeds from the offering to
support its growing commercial capabilities for Libmeldy, prepare
for a potential U.S. approval for OTL-200 and advance its HSC gene
therapy portfolio. The company expects that its existing cash, cash
equivalents and investments, inclusive of the proceeds from the
second closing, will fund its anticipated operating, debt service
and capital expenditure requirements into mid-2025, with the
potential for additional runway extension pending the exercise of
the warrants issued as part of the financing.
The securities were sold in a private placement and have not
been registered under the Securities Act of 1933, as amended
(Securities Act), and may not be offered or sold in the U.S. absent
registration or an applicable exemption from registration
requirements. The Company has agreed to file a resale registration
statement with the U.S. Securities and Exchange Commission (SEC),
for purposes of registering the resale of the ordinary shares
issued or issuable in connection with the offering.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy the securities, nor shall there be
any sale of the securities in any state in which such offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of such state. Any offering
of the securities under the resale registration statement will only
be by means of a prospectus.
About Orchard Therapeutics
At Orchard Therapeutics, our vision is to end the devastation
caused by genetic and other severe diseases. We aim to do this by
discovering, developing and commercializing new treatments that tap
into the curative potential of hematopoietic stem cell (HSC) gene
therapy. In this approach, a patient’s own blood stem cells are
genetically modified outside of the body and then reinserted, with
the goal of correcting the underlying cause of disease in a single
treatment.
In 2018, the company acquired GSK’s rare disease gene therapy
portfolio, which originated from a pioneering collaboration between
GSK and the San Raffaele Telethon Institute for Gene Therapy in
Milan, Italy. Today, Orchard is advancing a pipeline spanning
pre-clinical, clinical and commercial stage HSC gene therapies
designed to address serious diseases where the burden is immense
for patients, families and society and current treatment options
are limited or do not exist.
Orchard has its global headquarters
in London and U.S. headquarters in Boston. For
more information, please visit www.orchard-tx.com, and follow
us on Twitter and LinkedIn.
Availability of Other Information About
Orchard
Investors and others should note that Orchard communicates with
its investors and the public using the Company website
(www.orchard-tx.com), the investor relations website
(ir.orchard-tx.com), and on social media (Twitter
and LinkedIn), including but not limited to investor
presentations and investor fact sheets, SEC filings,
press releases, public conference calls and webcasts. The
information that Orchard posts on these channels and websites could
be deemed to be material information. As a result, Orchard
encourages investors, the media, and others interested in Orchard
to review the information that is posted on these channels,
including the investor relations website, on a regular basis. This
list of channels may be updated from time to time on Orchard’s
investor relations website and may include additional social media
channels. The contents of Orchard’s website or these channels, or
any other website that may be accessed from its website or these
channels, shall not be deemed incorporated by reference in any
filing under the Securities Act.
Forward-Looking Statements
This press release contains forward-looking
statements, which are made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. All
statements that are not statements of historical facts are, or may
be deemed to be, forward-looking statements. Such forward-looking
statements may be identified by words such as “expects,”
“potential,” “could,” or similar expressions that are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements include express or implied statements
relating to, among other things, Orchard’s business strategy and
goals, including its plans and expectations for the
commercialization of Libmeldy and the advancement of its clinical
and pre-clinical stage programs; statements relating to the private
placement, including the expected closings, the anticipated
proceeds from the private placement and the use thereof; Orchard’s
plans to file a resale registration statement to register the
shares issued and sold in the private placement and the issuance of
the shares issuable upon exercise of the warrants; Orchard’s future
capital needs and cash runway; the timing of Orchard’s expected BLA
filing with the FDA for OTL-200; and expectations related to the
occurrence and timing of the U.S. approval of OTL-200. These
statements are neither promises nor guarantees and are subject to a
variety of risks and uncertainties, many of which are beyond
Orchard’s control, which could cause actual results to differ
materially from those contemplated in these forward-looking
statements. In particular, these risks and uncertainties include,
without limitation, the risk that the warrants issued will not
become exercisable; the risk that Orchard is delayed in submitting
a BLA with the FDA for OTL-200; the risk that OTL-200 is not
approved by the FDA or that such approval is delayed; and the risk
that investors will not exercise the warrants or that only a
portion of the warrants will be exercised. Given these
uncertainties, the reader is advised not to place any undue
reliance on such forward-looking statements. Other risks and
uncertainties faced by Orchard include those identified under the
heading "Risk Factors" in Orchard’s most recent annual or quarterly
report filed with the SEC, as well as subsequent filings and
reports filed with the SEC. The forward-looking statements
contained in this press release reflect Orchard’s views as of the
date hereof, and Orchard does not assume and specifically disclaims
any obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as may be required by law.
Contact
Benjamin Navon+1
857-248-9454Benjamin.Navon@orchard-tx.com
Orchard Therapeutics (NASDAQ:ORTX)
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