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Cell Therapeutics Reports 76% Decrease in First Quarter 2009 Net Loss Attributable to Common Shareholders; Completion of Pixantrone NDA Submission on Track for Second Quarter 2009
Pixantrone Named-Patient Program Initiated in
"Our focus for the first half of 2009 was to initiate and complete the NDA submission for pixantrone while we implemented final steps in our cost cutting efforts and raised much needed operating capital on the least dilutive terms possible -- all while cleaning up the Company's capital structure," said
Recent Highlights
- Initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pixantrone and are targeting completing this NDA submission in
June 2009 , which if granted priority review could lead to an FDA approval decision as early asDecember 2009 . - Pixantrone Phase III study results to be presented at the American Society of Clinical Oncology Conference on
June 1, 2009 . - Pixantrone is now available through a named-patient program in
Europe . - Raised
$23.8 million through the sale of Series 1 Preferred Stock to a single institutional investor and upon the exercise of the associated common stock warrants. The investor subsequently converted 100% of the Series 1 Preferred Stock to common stock. CTI has no remaining issued or outstanding preferred stock. - Received
$20.5 million in gross proceeds in 2009 from Spectrum Pharmaceuticals, Inc. associated with the initial divestiture of Zevalin to the joint venture with Spectrum and the subsequent sale of CTI's remaining interest in this joint venture (total$28.0 million received to date with up to an additional$3.5 million owed).
Total net operating expenses decreased
CTI had approximately
Conference Call Information
On
Conference Call Numbers
Thursday, May 7
8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-888-561-1799 (US Participants)
1-480-629-9867 (International)
Call-back numbers for post-listening available at 11:30 a.m. Eastern:
1-800-406-7325 (US Participants)
1-303-590-3030 (International)
Passcode: 4066143
Live audio webcast at www.celltherapeutics.com will be archived for post listening approximately two hours after call ends.
About Cell Therapeutics, Inc.
Headquartered in
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the results of complete safety information, the failure to receive anticipated number of requests for pixantrone to treat specific patients, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the possibility that the NDA submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 2009, the possibility that we may not receive all of the additional amount owed to us by Spectrum, our ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in our filings with the Securities and Exchange Commission including, without limitation, our most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by law, we do not intend to update or alter our forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
F: 206.272.4434
E: media@ctiseattle.com
www.celltherapeutics.com/media.htm
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.celltherapeutics.com/investors.htm
Three Months Ended
March 31,
---------
2009 2008
---- ----
Revenues:
Product sales $- $3,374
License and contract revenue 20 20
-- --
Total revenues 20 3,394
-- -----
Operating expenses, net:
Cost of product sold - 890
Research and development 7,956 15,855
Selling, general and administrative 8,874 11,210
Amortization of purchased intangibles - 397
Gain on sale of Zevalin (10,244) -
------- ---
Total operating expenses, net 6,586 28,352
----- ------
Loss from operations (6,566) (24,958)
Other income (expense):
Investment and other income, net 34 260
Interest expense (1,617) (1,985)
Amortization of debt discount and
issuance costs (4,851) (10,944)
Foreign exchange gain (loss) 41 (2,237)
Make-whole interest expense (6,345) (7,781)
Gain on derivative liabilities, net 5,622 11,744
Loss on exchange of convertible notes - (2,295)
Equity loss from investment in
joint venture (1,204) -
Settlement expense (170) -
---- ---
Net loss before
noncontrolling
interest (15,056) (38,196)
Noncontrolling interest 89 32
-- --
Net loss attributable to CTI (14,967) (38,164)
Gain on restructuring of
preferred stock 2,116 -
Preferred stock dividends (23) (242)
Deemed dividends on conversion
of preferred stock (250) (16,198)
---- -------
Net loss attributable
to CTI common shareholders $(13,124) $(54,604)
======== ========
Basic and diluted net loss
per common share $(0.05) $(7.68)
====== ======
Shares used in calculation
of basic and diluted
net loss per common share (1) 285,525 7,107
======= =====
Balance Sheet Data: (amounts in thousands)
March 31, December 31,
2009 2008
---- ----
(unaudited)
Cash and cash equivalents
and securities available-for-sale $748 $10,671
Restricted cash - 6,640
Working capital (22,776) (14,141)
Total assets 42,933 64,243
Convertible debt 119,030 142,373
Accumulated deficit (1,325,444) (1,312,320)
Total deficit (115,984) (132,061)
(1) Amounts reflect a one-for-ten reverse stock split of our
common stock effective August 31, 2008.
SOURCE Cell Therapeutics, Inc.













