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Cell Therapeutics, Inc. (CTI) Reduces Net Loss for Third Quarter and Nine Months Ended September 30, 2012 Compared to Same

  Cell Therapeutics, Inc. (CTI) Reduces Net Loss for Third Quarter and Nine
       Months Ended September 30, 2012 Compared to Same Periods in 2011

Recent Company Highlights

- Pixuvri made commercially available as monotherapy for the treatment of
adult patients with multiply relapsed or refractory aggressive non-Hodgkin
B-cell lymphoma ("NHL") in Sweden, Denmark, Finland and Austria.

- Selected clinical research organization ("CRO") and identified sites in
preparation for phase 3 clinical trial of pacritinib, a highly selective JAK2
inhibitor, for treatment of patients with myelofibrosis ("MF"), which is
expected to start in Q4 2012.

- Received orphan drug designation of OPAXIO for glioblastoma multiforme, a
malignant brain cancer.

- Published clinical study of pacritinib in relapsed/refractory lymphoma in
the Journal of Clinical Oncology and a preclinical study CT-1578 in the
Journal of Immunology.

- Announced the appointment of Matthew J. Plunkett, Ph.D., as CTI's Executive
Vice President, Corporate Development, former Director and Head of West Coast
Biotechnology for Oppenheimer & Co. and its U.S. predecessor, CIBC World
Markets.

- Raised approximately $55.6 million in net proceeds in an underwritten public
offering.

PR Newswire

SEATTLE, Nov. 1, 2012

SEATTLE, Nov. 1, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI" or the
"Company") (NASDAQ and MTA: CTIC) today reported financial results for the
third quarter of 2012 and recent accomplishments.

Financial Results

Third Quarter Results

For the quarter endedSeptember 30, 2012, total operating expenses were$14.7
millioncompared to$15.3 millionfor the same period in 2011. Net loss
attributable to common shareholders was$20.2 million($0.38per share) for
the quarter endedSeptember 30, 2012 compared to a net loss attributable to
common shareholders of$29.7 million($0.80per share) for the same period in
2011. The decrease in net loss attributable to CTI's common shareholders is
primarily due to a decrease in non-cash deemed dividends on preferred stock
issuances. The decline in dividends and deemed dividends on preferred stock
between the comparable periods is attributable to the total dollar amounts of
the equity offerings completed.

Nine-Month Results

For the nine months endedSeptember 30, 2012, total operating expenses
were$82.2 millioncompared to$52.3 millionfor the same period in 2011. Most
of the increase in operating expenses is primarily related to the $29.1
million acquired in-process research and development expense related to the
acquisition of pacritinib from S*BIO Pte Ltd. in 2012. Net loss attributable
to common shareholders was$96.2 million($2.12per share) for the nine months
endedSeptember 30, 2012 compared to a net loss attributable to common
shareholders of$103.2 million($3.11per share) for the same period in 2011.
The decrease in net loss attributable to CTI's common shareholders is
primarily due to a decrease in non-cash deemed dividends on preferred stock
issuances. The decline in dividends and deemed dividends on preferred stock
between the comparable periods is attributable to the total dollar amounts of
the equity offerings completed.

In June 2012, CTI completed the acquisition of pacritinib from S*BIO Pte Ltd.
As a result of this acquisition, CTI realized an acquisition-related expense
of $29.1 million for acquired in-process research and development. On a
non-GAAP ("Generally Accepted Accounting Principles") basis to exclude this
acquired in-process research and development expense, non-GAAP operating
expenses were $53.1 million for the nine months ended September 30, 2012
compared to $52.3 million for the same period in 2011. Non-GAAP net loss
attributable to common shareholders, excluding the in-process research and
development expense, was $67.1 million ($1.51 per share), for the nine months
ended September 30, 2012 compared to a net loss attributable to common
shareholders of $103.2 million ($3.11 per share).

Non-GAAP operating expenses and non-GAAP net loss attributable to common
shareholders excludes in-process research and development expenses related to
the acquisition. For more information regarding CTI's use of non-GAAP
measures, please refer to the section entitled "Non-GAAP Financial Measures"
and to the reconciliation of CTI's non-GAAP financial measures to their most
directly comparable GAAP measures, which have been provided in the financial
statement tables included elsewhere in this press release.

CTI had approximately$14.3 million in cash and cash equivalents as
ofSeptember 30, 2012. In October 2012, CTI raised approximately$55.6
millionin net proceeds from the sale of CTI's Series 17 convertible preferred
stock in a public underwritten offering.

"In the third quarter, we achieved our goal of making Pixuvri commercially
available in the European Union ("E.U."). Pixuvri is now commercially
available in Sweden, Denmark and Finland as well as Austria and we continue
the roll-out with entry into Germany, the United Kingdom and the Netherlands
scheduled in November," stated James A. Bianco, M.D., President and CEO of
CTI. "We expect to begin a phase 3 study of pacritinib in MF this quarter and
have the CRO in place that will conduct the study and we have identified
leading institutions that will participate in the study. We believe that
strong institutional investor interest in the opportunity for Pixuvri in the
E.U. and pacritinib's product profile in MF, in addition to our other pipeline
assets, drove the recent successful completion of our financing of
approximately $55.6 million in net proceeds. We believe this financing will
help provide us with additional resources to reach significant milestones in
the development of our pipeline."

Conference Call Information

On Nov. 1, 2012, at 8:30 a.m. Eastern/1:30 p.m. Central European/5:30 a.m.
Pacific Time, members of CTI's management team will host a conference call to
discuss CTI's 2012 third quarter financial results.

Conference Call Numbers Nov. 1, 2012, at 8:30 a.m. Eastern/1:30 p.m. Central
European/5:30 a.m. Pacific Time 1-877-941-2333 (US Participants) 1-480-
629-9773 (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:
4572038 #

Live audio webcast at www.celltherapeutics.com will be archived for post-call
listening approximately two hours after call ends.

About Pixuvri (pixantrone)

Pixuvri is a novel aza-anthracenedione with unique structural and
physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA
adducts and in preclinical models has superior anti-lymphoma activity compared
to related compounds. Pixuvri was structurally designed so that it cannot bind
iron and perpetuate oxygen radical production or form a long-lived hydroxyl
metabolite -- both of which are the putative mechanisms for anthracycline
induced acute and chronic cardiotoxicity. These novel pharmacologic properties
allow Pixuvri to be administered to patients with near maximal lifetime
exposure to anthracyclines without unacceptable rates of cardiotoxicity, and,
because Pixuvri is not a vesicant, allow it to be safely delivered via a
peripheral intravenous catheter.

In May 2012, Pixuvri received conditional marketing authorization in the E.U.
as monotherapy for the treatment of adult patients with multiply relapsed or
refractory aggressive NHL. The benefit of pixantrone treatment has not been
established in patients when used as fifth line or greater chemotherapy in
patients who are refractory to last therapy. The Summary of Product
Characteristics ("SmPC") has the full prescribing information, including the
safety and efficacy profile of Pixuvri in the approved indication. The SmPC is
available at www.pixuvri.eu. 

CTI is currently accruing patients into a Phase 3 trial comparing pixantrone
and rituximab with gemcitabine and rituxan in the setting of aggressive B-cell
NHL. We expect that European sites will be participating in this study later
this year.

Pixuvri is currently available in the E.U. through Named Patient Programs.

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing Authorization

Similar to accelerated approval regulations inthe United States, conditional
marketing authorizations are granted in the E.U. to medicinal products with a
positive benefit/risk assessmentthat address unmet medical needs and whose
availability would result in a significant public health benefit. A
conditional marketing authorization is renewable annually. Under the
provisions of the conditional marketing authorization for Pixuvri, CTI will be
required to complete a post-marketing study aimed at confirming the clinical
benefit previously observed.

The European Medicines Agency's (the "EMA") Committee for Medicinal Products
for Human Use has accepted PIX306, CTI's ongoing randomized controlled phase
III clinical trial, which compares Pixuvri-rituximab to gemcitabine-rituximab
in patients who have relapsed after one to three prior regimens for aggressive
B‑cellNHL and who are not eligible for autologous stem cell transplant. As a
condition of approval, CTI has agreed to have available the PIX306 clinical
trial results byJune 2015.

About Pacritinib

Pacritinib is an oral, once a day, tyrosine kinase inhibitor (TKI) with dual
activity against JAK2 and FMS-like tyrosine kinase 3 ("FLT3"). Mutations in
these kinases have been shown to be directly related to the development of a
variety of blood related cancers including other myeloproliferative neoplasms
("MPNs"), leukemia and lymphoma. Pacritinib has demonstrated encouraging
results in phase 1 and 2 studies for patients with myelofibrosis and a phase 3
study is planned for this disease. FLT3 is a commonly mutated gene found in
acute myeloid leukemia ("AML") patients and its activating mutations have been
proven to be a negative prognostic marker for clinical outcome suggesting a
possible future role for treatment of AML.

Non-GAAP Financial Measures

In June 2012, CTI completed the acquisition of pacritinib from S*BIO Pte Ltd.
CTI has provided in this press release the non-GAAP financial measures of
non-GAAP operating expenses, non-GAAP net loss attributable to common
shareholders, and non-GAAP basic and diluted net loss per share each for the
nine months ended September 30, 2012. The definition of these non-GAAP
financial measures may differ from similarly titled measures used by other
companies. CTI believes that presenting these non-GAAP financial measures,
which exclude the acquisition-related acquired in-process research and
development expense, is a useful supplement to GAAP financial measures for
both management and investors in evaluating CTI's ongoing operating results
and performance over time, and comparing CTI's performance with other
reporting periods.

Non-GAAP financial measures have limitations as an analytical tool and should
not be considered in isolation from, or as a substitute for, financial
information prepared in accordance with GAAP. Investors are encouraged to
review the reconciliation of these non-GAAP measures to their most directly
comparable GAAP financial measures. A reconciliation of CTI's non-GAAP
financial measures to their most directly comparable GAAP measures has been
provided in the financial statement tables included below in this press
release.

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.

Sign up for email alerts and get RSS feeds at our Web site,
http://www.CellTherapeutics.com/investors_alert

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 CTI's
securities. The risks and uncertainties that could affect the development of
Pixuvri, pacritinib, tosedostat or OPAXIO include risks associated with
preclinical and clinical developments in the biopharmaceutical industry in
general and with Pixuvri, pacritinib, tosedostat or OPAXIO in particular
including, without limitation, the potential failure of Pixuvri to prove safe
and effective for the treatment of relapsed or refractory NHL and/or other
tumors as determined by the U.S. Food and Drug Administration (the "FDA");
that CTI's plan to make Pixuvri commercially available in additional countries
in Europe, including Germany, the United Kingdom and the Netherlands, may not
occur as planned; that CTI may not be able to complete the PIX306 clinical
trial of Pixuvri-rituximab compared to gemcitabine-rituximab in patients who
have relapsed after 1 to 3 prior regimens for aggressive B‑cellNHL and who
are not eligible for autologous stem cell transplant by June 2015 or at all as
required by the EMA; that CTI may not have the results of the PIX306 clinical
trial available by June 2015 or at all; that CTI may not be able complete a
post-marketing study aimed at confirming the clinical benefit observed in the
PIX301 trial; that the conditional marketing authorization for Pixuvri may not
be renewed; the potential that phase III studies of pacritinib might not begin
in the fourth quarter of 2012; orfailure of a pacritinib to prove safe and
effective for primary MF and MF secondary to other MPNs; the potential that
phase III studies of tosedostat may not occur as planned; the potential
failure of tosedostat to prove safe and effective for the treatment of elderly
patients with newly-diagnosed AML or high-risk myelodysplastic syndrome
("MDS") (including when administered in combination with cytarabine or
decitabine) as determined by the FDA and/or the EMA; the potential failure of
combination studies of tosedostat with hypomethylating agents in treating AML
and/or MDS; that the studies of tosedostat may not achieve their primary
and/or secondary objectives; that tosedostat may not be approved by the FDA
and/or the EMA; that CTI cannot guarantee or predict whether or not
orphan-drug designation of OPAXIO for glioblastoma multiforme will provide a
substantial benefit to CTI; that CTI cannot predict or guarantee the pace or
geography of enrollment of its clinical trials or the total number of patients
enrolled; that CTI's average net operating burn rate may increase; CTI's
ability to continue to raise capital as needed to fund its operations in
general; and risks related to competitive factors, technological developments,
costs of developing, producing, and selling Pixuvri, including, without
limitation, the risk factors listed or described from time to time in CTI's
filings with the Securities and Exchange Commission including, without
limitation, CTI's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as
may be required by law, CTI does not intend to update or alter its
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
E: deramian@ctiseattle.com
www.CellTherapeutics.com/press_room

Investors Contact:

Ed Bell
T: 206.282.7100
F: 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors





Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
(unaudited)
                          Three Months Ended       Nine Months Ended
                          September 30,            September 30,
                          2012        2011         2012           2011
Operating expenses:
 Research and             $         $          $          $    
 development              6,951       7,530        24,080        26,982
 Selling, general and     7,763       7,760        29,024         25,297
 administrative
 Acquired in-process
 research and             -           -            29,108         -
 development
      Total operating     14,714      15,290       82,212         52,279
      expenses
Loss from operations      (14,714)    (15,290)     (82,212)       (52,279)
Other income (expense):
 Investment and other     (270)       (14)         (179)          (67)
 income (expense), net
 Interest expense         (43)        (161)        (51)           (734)
 Amortization of debt
 discount and issuance    -           (129)        -              (436)
 costs
 Foreign exchange gain    216         (1,133)      (96)           (56)
 (loss)
 Settlement expense       (435)       -            (435)          -
Net loss before           (15,246)    (16,727)     (82,973)       (53,572)
noncontrolling interest
 Noncontrolling interest  57          65           200            179
Net loss attributable to  (15,189)    (16,662)     (82,773)       (53,393)
CTI
 Dividends and deemed
 dividends on preferred   (5,014)     (13,023)     (13,472)       (49,817)
 stock
Net loss attributable to  $ (20,203)  $ (29,685)   $          $  
CTI common shareholders                            (96,245)       (103,210)
Basic and diluted net     $         $          $        $     
loss per common share    (0.38)      (0.80)       (2.12)         (3.11)
Shares used in
calculation of basic and
diluted
net loss per common       52,921      36,999       45,442         33,145
share
Balance Sheet Data                                 (amounts in thousands)
(unaudited):
                                                   September 30,  December 31,
                                                   2012           2011
Cash and cash                                      $          $    
equivalents                                       14,289        47,052
Working capital                                    (7,065)        33,291
Total assets                                       36,175         62,239
Accumulated deficit                                (1,811,030)    (1,714,785)
Total shareholders'                                (9,895)        28,009
equity (deficit)



Non-GAAP Reconciliations
(In thousands, except for per share amounts)
(unaudited)
                                                            Nine Months Ended
                                                            September 30,
                                                            2012
As Reported total operating expenses (GAAP)                 $     82,212
As Reported acquired in-process research and development    $     29,108
(GAAP)
As Adjusted total operating expenses (Non-GAAP)             $     53,104
                                                            Nine Months Ended
                                                            September 30,
                                                            2012
As Reported net loss attributable to CTI common             $     (96,245)
shareholders (GAAP)
As Reported acquired in-process research and development    $      29,108
(GAAP)
As Adjusted net loss attributable to CTI common             $     (67,137)
shareholders (Non-GAAP)
                                                            Nine Months Ended
                                                            September 30,
                                                            2012
As Reported shares used in calculation of basic and diluted 45,442
net loss per common share (GAAP)
Weighted average common shares issued in connection with    855
the acquisition of assets of S*BIO Pte Ltd. (GAAP)
As Adjusted shares used in calculation of basic and diluted 44,587
net loss per common share (Non-GAAP)
                                                            Nine Months Ended
                                                            September 30,
                                                            2012
As Adjusted net loss attributable to CTI common             $     (67,137)
shareholders (Non-GAAP) - see above
As Adjusted shares used in calculation of basic and diluted 44,587
net loss per common share (Non-GAAP) - see above
As Adjusted basic and diluted net loss per common share     $      
(Non-GAAP)                                                  (1.51)



SOURCE Cell Therapeutics, Inc.

Website: http://www.celltherapeutics.com
 
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