Gentium Spa (AMEX:GNT)
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From Jun 2019 to Jun 2024
Gentium S.p.A. (AMEX:GNT) (the "Company") announced
today that it has entered into definitive agreements for a $10.9
million private placement of 1.551,125 million of its American
Depository Shares (ADSs) at a price of $7.05 per ADS. Subject to
shareholder approval, investors in the financing will also receive
warrants to purchase 620,452 ADSs at an exercise price of $9.69 per
share. The closing is subject to certain conditions precedent to the
closing. The purchase price is subject to reduction of 20% if the
Company's shareholders do not approve the issuance of the warrants
within 180 days. Funds managed by Great Point Partners, LLC were the
lead investors in the transaction. Rodman & Renshaw LLC acted as the
lead placement agent for the offering, and Maxim Group LLC and
I-Bankers Securities Incorporated were co-placement agents.
The net proceeds from the offering will be used to fund additional
costs relating to the Company's upcoming Phase III trial of
Defibrotide to treat Severe VOD, the Company's portion of the costs
related to the recently announced Phase I/II trial of Defibrotide to
treat Multiple Myeloma, the continued development of the Company's
other product candidates and for general corporate purposes.
Dr. Laura Ferro, Gentium's Chairman and Chief Executive Officer,
said, "Recent developments, including the announcement of our upcoming
Phase III trial and our participation in an independent trial using
Defibrotide to treat Multiple Myeloma, underscore the progress and
exciting potential for Defibrotide in a number of target therapeutic
areas."
"This financing strengthens our balance sheet and allows us more
flexibility in the timing of commencing some of our clinical trials.
In addition, it gives us the capital to negotiate new drug development
and licensing agreements from a position of strength. We are pleased
with the support shown by some of our existing shareholders as well as
by the enthusiasm of recognized biotech investors such as Great Point
Partners and RA Capital Management, who have participated in this
financing," concluded Dr. Ferro.
David Kroin, a Managing Director of Great Point Partners, LLC,
said, "We are excited to become an investor in Gentium. Our
discussions with leading clinicians and researchers led us to the
conclusion that Defibrotide has great potential for its
investigational uses as well as holding promise in a number of
additional indications. VOD is a devastating disease and we are
excited to be associated with the development of this unique compound
which may be the first available to significantly reduce its
mortality."
The ADSs sold in the private placement and the shares issuable
upon exercise of the related warrants have not been registered under
the Securities Act of 1933, as amended, or state securities laws, and
may not be offered or sold in the United States without being
registered with the Securities and Exchange Commission (SEC) or
through an applicable exemption from SEC registration requirements.
The shares were offered (and will be sold) only to qualified
institutional buyers and a limited number of accredited investors. The
Company has agreed to file a registration statement with the SEC
covering the resale of the ADSs issued in the private placement and
issuable upon exercise of the warrants.
About VOD
Severe VOD is a potentially life-threatening condition in which
some of the veins in the liver are blocked as a result of toxic cancer
treatments such as chemotherapy, radiation, hormone therapy and bone
marrow and stem cell transplants. Based on the Company's review of
more than 200 published papers in the medical literature, it is
estimated that approximately 80% of patients with Severe VOD die
within 100 days without treatment. There are no currently approved
treatments for Severe VOD.
About the Company
Gentium S.p.A. is a biopharmaceutical company located in Villa
Guardia (Como), Italy that is focused on the research, discovery and
development of drugs derived from DNA extracted from natural sources,
and drugs which are synthetic derivatives, to treat and prevent a
variety of vascular diseases and conditions related to cancer and
cancer treatments. Defibrotide, the Company's lead product candidate
in the U.S., is an investigational drug that has been granted Orphan
Drug status by the U.S. FDA to treat veno-occlusive disease (VOD) with
multiple organ failure ("Severe VOD") and Fast Track designation for
the treatment of Severe VOD in recipients of stem cell transplants.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements." In some
cases, you can identify these statements by forward-looking words such
as "may," "might," "will," "should," "expect," "plan," "anticipate,"
"believe," "estimate," "predict," "potential" or "continue," the
negative of these terms and other comparable terminology. These
statements are not historical facts but instead represent the
Company's belief regarding future results, many of which, by their
nature, are inherently uncertain and outside the Company's control. It
is possible that actual results may differ, possibly materially, from
those anticipated in these forward-looking statements. For a
discussion of some of the risks and important factors that could
affect future results, see the discussion in our Prospectus filed with
the Securities and Exchange Commission under Rule 424(b)(4) under the
caption "Risk Factors."
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