05.10.2007 20:30:00
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Required NASDAQ Release by pSivida
pSivida Limited (NASDAQ:PSDV)(ASX:PSD)(Xetra:PSI) today announced that
its financial statements for the fiscal year ended June 30, 2007
included in the Company’s Form 20-F filed on
October 1, 2007, contain a going concern qualification from its
independent accounting firm, Deloitte Touche Tohmatsu. The independent
auditor’s opinion noted the Company’s
recurring losses from operations and negative cash flows from operations.
In July 2007, pSivida raised approximately US$20.6 million through the
sale of shares, ADSs and warrants, including a placement of US$6.5
million to Pfizer Inc., the Company’s largest
shareholder. This investment and Pfizer's earlier equity investment of
US$5 million were made under a collaborative research and licensing
agreement that provides for a total of up to US$165 million in equity
investments and development and sales-related milestones. The Company
expects to receive certain research and development funding from Pfizer
under the agreement, commencing in January 2008. The Company is now debt
free, having repaid all its outstanding debt during the year ended June
30, 2007. The Company believes that its existing cash resources are
sufficient to fund its operations as currently conducted through at
least June 30, 2008.
This announcement is being made in compliance with Nasdaq Marketplace
Rule 4350(b)(1)(B), which requires separate disclosure of receipt of an
audit opinion that contains a going concern qualification. This
announcement does not represent any change or amendment to the Company's
fiscal 2007 financial statements or to its Annual Report on Form 20-F.
NOTES TO EDITORS:
pSivida is a global drug delivery company committed to the biomedical
sector and the development of drug delivery products. Retisert®
is FDA approved for the treatment of uveitis. Vitrasert®
is FDA approved for the treatment of AIDS-related CMV Retinitis. Bausch
& Lomb owns the trademarks Vitrasert® and
Retisert®. pSivida has licensed the
technologies underlying both of these products to Bausch & Lomb. The
technology underlying Medidur™ for diabetic
macular edema is licensed to Alimera Sciences and is in Phase III
clinical trials. pSivida has a worldwide collaborative research and
license agreement with Pfizer Inc. for other ophthalmic applications of
the Medidur™ technology.
pSivida owns the rights to develop and commercialize a modified form of
silicon (porosified or nano-structured silicon) known as BioSilicon™,
which has applications in drug delivery, wound healing, orthopedics, and
tissue engineering. The most advanced BioSilicon™
product, BrachySil™ delivers a therapeutic,
P32 directly to solid tumors and is presently in Phase II clinical
trials for the treatment of pancreatic cancer.
pSivida’s intellectual property portfolio
consists of 71 patent families, 99 granted patents, including patents
accepted for issuance, and over 300 patent applications. pSivida
conducts its operations from facilities near Boston in the United
States, Malvern in the United Kingdom and Perth in Australia.
pSivida is listed on NASDAQ (PSDV), the Australian Stock Exchange
(PSD) and on the Frankfurt Stock Exchange on the XETRA system (PSI).
pSivida is a founding member of the NASDAQ Health Care Index and the
Merrill Lynch Nanotechnology Index.
Various statements made in this release are forward-looking and involve
a number of risks and uncertainties. All statements that address
activities, events or developments that we intend, expect or believe may
occur in the future are forward-looking statements. The following are
some of the factors that could cause actual results to differ materially
from the forward-looking statements: the risks that we will not be able
to raise additional capital; that we will continue to incur losses and
may never become profitable; that we will be required to pay penalties
pursuant to registration agreements with securities holders and not have
sufficient funds to do so; that we will be unable to develop new
products; that we will be unable to protect our own intellectual
property or will infringe on others’
intellectual property; that we will not receive regulatory approvals
necessary to commercialize products; that we will be unable to secure
partners necessary to develop and market products; that our current
licensees will terminate their agreements with us; that our competitors’
products will receive regulatory approval before, reach the market
before, or otherwise receive better market acceptance than, our product
candidates; that our international business operations will result in
increased costs or delays; that manufacturing problems will delay
product development and commercialization; that third-party
reimbursement and health care providers will not cover the costs of our
products; that we will fail to retain some or all of our key personnel;
we will be subject to product liability suits and not have sufficient
insurance to cover damages; that we will fail to effectively manage
changes in our business; that we will fail to comply with environmental
laws and regulations; that we will fail to achieve and maintain
effective internal control over financial reporting; that amortization
or impairment of other intangibles will adversely affect our operating
results; that our being headquartered outside of the United States will
make it difficult to effect legal services against us or our management,
lead to adverse shareholder tax consequences, or otherwise limit
shareholder rights; that we will be delisted from the ASX or NASDAQ;
that our expectation to not pay cash dividends will decrease our stock
price; that exercise of outstanding warrants and stock options will
dilute ownership and reduce stock price; that future stock issuances
could dilute ownership, restrict operations, encumber assets, or
otherwise cause a decline in stock price; and the risk that Pfizer will
influence our business in non-beneficial ways; and other factors that
may be described in our filings with the Securities and Exchange
Commission. Given these uncertainties, readers are cautioned not to
place undue reliance on such forward-looking statements. We do not
undertake to publicly update or revise our forward-looking statements
even if experience or future changes make it clear that any projected
results expressed or implied in such statements will not be realized.
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