


SEATTLE, Aug. 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI" or the "Company") (Nasdaq and MTA: CTIC) today reported recent accomplishments and financial results for the second quarter ended June 30, 2010.
"We continue to make progress on moving the pixantrone Marketing Authorization Application ("MAA") forward in Europe with the submission of a revised and expanded Pediatric Investigation Plan ("PIP") as part of the application filing for an MAA in Europe. In the U.S., we look forward to meeting with the U.S. Food and Drug Administration (the "FDA") in August to discuss our proposed new combination trial for pixantrone in aggressive non-Hodgkin's lymphoma ("NHL")," said James A. Bianco, M.D., Chief Executive Officer of the Company. "On the financial front, we have retired all of our convertible debt due in 2010 and removed that obligation from our balance sheet leaving only two convertible debt maturities remaining in April and December of next year for a total of $21 million."
Recent Highlights
-- Submitted revised and expanded PIP for pixantrone as part of the MAA
submission process. The company plans to submit an MAA for pixantrone in
the second half 2010.
-- Signed a long-term manufacturing agreement with NerPharMa S.r.l (a
pharmaceutical manufacturing company belonging to Nerviano Medical
Sciences S.r.l. in Nerviano, Italy) for pixantrone.
-- Submitted a proposal for a new clinical trial for pixantrone in
aggressive NHL under the FDA's Special Protocol Assessment process.
-- Retired all convertible debt due in 2010 including principal and
interest with a payment of $39.3 million.
-- Reported exploratory analyses from pivotal trial presented at an
advisory panel during the 15th Congress of the European Hematology
Association Reported demonstrated that complete responses to pixantrone
are correlated with prolonged survival in patients with relapsed or
refractory aggressive NHL.
-- Initiated two phase II programs with the Mayo Clinic's clinical trial
network, North Central Cancer Treatment Group: one program with
pixantrone in metastatic breast cancer and one trial using brostallicin
in triple negative metastatic breast cancer.
-- At the American Society of Clinical Oncology Annual Meeting in June, the
Company reported on the positive results of a phase II study using
OPAXIO as a radiosensitizer in the treatment of esophageal cancer.
For the quarter ended June 30, 2010, total net operating expenses were $20.0 million compared to $21.7 million for the same period in 2009. Net loss attributable to common shareholders was $53.6 million ($0.08 per share) for the quarter ended June 30, 2010 compared to a net loss attributable to common shareholders of $27.4 million ($0.06 per share) for the same period in 2009. The increase in net loss is mainly due to non-cash expenses. These non-cash expenses included $30.2 million in deemed dividends on preferred stock and $7.6 million in equity based compensation for the quarter ended June 30, 2010.
For the six months ended June 30, 2010, total net operating expenses were $45.8 million, compared to $28.3 million for the same period in 2009. The increase in net operating expenses is mainly a result of a $15.3 million non-cash equity based compensation expense in the first half of 2010 and a $10.2 million gain on the sale of the Company's investment in the Zevalin joint venture in the first quarter of 2009. Net loss attributable to common shareholders was $97.8 million ($0.15 per share), compared to a net loss attributable to common shareholders of $40.6 million ($0.11 per share) for the same period in 2009. For the six month period, the increase in net loss is mainly due to non-cash expenses including $47.4 million in deemed dividends on preferred stock and $15.3 million in equity based compensation for the first half of 2010.
CTI had approximately $64.5 million in cash and cash equivalents as of June 30, 2010. This amount was before the payment of $39.3 million for retirement of the convertible debt due in 2010, which was paid off in early July 2010, and the receipt of $4.1 million in gross proceeds received from the Company's equity financing in July 2010.
Conference Call Information
On Thursday, August 5, 2010, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time, members of CTI's management team will host a quarterly conference call to discuss CTI's 2010 second quarter achievements and financial results.
Conference Call Numbers
Thursday, August 5, 2010 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-877-941-2930 (US Participants)
1-480-629-9690 (International)
Call-back numbers for post-listening available at 11:30 a.m. Eastern Time:
1-800-406-7325 (US Participants)
1-303-590-3030 (International)
Passcode: 4329084#
Live audio webcast at www.celltherapeutics.com will be archived for post-call listening approximately two hours after call ends.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.
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 and the market price of the Company's securities. 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 potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory aggressive NHL and/or other tumors as determined by the FDA and/or the EMEA, that the FDA may not accept the Company's SPA and/or proposed design for the protocol of the Company's clinical trial and/or may request additional clinical trials, that if the Company conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that the Company cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that the Company may not initiate a new clinical trial for pixantrone in 2010, that the Company may not submit the MAA during the second half of 2010, that the EMEA may not accept the MAA, that the EMEA may not accept the PIP, that the Company may not be able to retire its 2011 debt, and the Company's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone. Further risks and uncertainties include that the Company continues to have a substantial amount of debt outstanding and the quarterly interest expense associated with the debt is significant, the Company's operating expenses continue to exceed its net revenues, that the Company may not be able to further reduce its operating expenses, that the Company will continue to need to raise capital to fund its operating expenses and may not be able to raise sufficient amounts to fund its continued operation, and that the Company may not obtain shareholder approval to amend the Company's amended and restated articles of incorporation to increase the Company's authorized shares of common stock at the Company's Annual Meeting of Shareholders scheduled to be held on September 16, 2010, as well as other risks listed or described from time to time in the Company's most recent filings with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by law, the Company does not intend to update any of the statements in this press release upon further developments.
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
F: 206.272.4434
E: deramian@ctiseattle.com
www.celltherapeutics.com/media.htm
Investors Contact:
Ed Bell
T: 206.282.7100
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
http://www.celltherapeutics.com/investors
Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
(unaudited)
Three Months
Ended Six Months Ended
June 30, June 30,
-------- --------
2010 2009 2010 2009
---- ---- ---- ----
Revenues:
License and
contract revenue $299 $20 $319 $40
---- --- ---- ---
Total revenues 299 20 319 40
--- --- --- ---
Operating
expenses, net:
Research and
development 6,914 7,320 14,274 15,276
Selling, general
and
administrative 13,068 10,580 31,485 19,330
Restructuring
charges - 3,820 - 3,944
Gain on sale of
investment in
joint venture - - - (10,244)
--- --- --- -------
Total operating
expenses, net 19,982 21,720 45,759 28,306
------ ------ ------ ------
Loss from
operations (19,683) (21,700) (45,440) (28,266)
Other income
(expense):
Investment and
other income,
net 1 37 263 71
Interest expense (776) (1,583) (1,563) (3,200)
Amortization of
debt discount
and issuance
costs (219) (497) (434) (5,348)
Foreign exchange
gain (loss) (825) 54 (1,300) 95
Debt conversion
expense (2,031) - (2,031) -
Make-whole
interest expense - - - (6,345)
Gain on
derivative
liabilities, net - 1,596 - 7,218
Gain on exchange
of convertible
notes - 7,201 - 7,201
Equity loss from
investment in
joint venture - - - (1,204)
Settlement
expense, net - (3,198) - (3,368)
--- ------ --- ------
Net loss before
noncontrolling
interest (23,533) (18,090) (50,505) (33,146)
Noncontrolling
interest 51 63 103 152
--- --- --- ---
Net loss
attributable to
CTI (23,482) (18,027) (50,402) (32,994)
Gain on
restructuring of
preferred stock - - - 2,116
Preferred stock
dividends - (1) - (24)
Deemed dividends
on preferred
stock (30,157) (9,398) (47,434) (9,648)
------- ------ ------- ------
Net loss
attributable to
CTI common
shareholders $(53,639) $(27,426) $(97,836) $(40,550)
======== ======== ======== ========
Basic and diluted
net loss per
common share $(0.08) $(0.06) $(0.15) $(0.11)
====== ====== ====== ======
Shares used in
calculation of
basic and
diluted
net loss per
common share 665,963 446,174 632,658 366,293
======= ======= ======= =======
(amounts in
Balance Sheet Data: thousands)
-----------
December
June 30, 31,
2010 2009
---- ----
(unaudited)
Cash and cash
equivalents $64,534 $37,811
Working capital 3,295 (21,694)
Total assets 94,578 69,595
Convertible debt 60,553 62,142
Accumulated deficit (1,526,919) (1,429,083)
Total shareholders'
equity (deficit) 4,616 (18,769)
SOURCE Cell Therapeutics, Inc.




