Cell Therapeutics Reports First Quarter 2013 Financial Results

        Cell Therapeutics Reports First Quarter 2013 Financial Results

- Conference call scheduled today at 4:30 p.m. Eastern time -

PR Newswire

SEATTLE, May 2, 2013

SEATTLE, May 2, 2013 /PRNewswire/ -- Cell Therapeutics, Inc.(CTI) (NASDAQ and
MTA: CTIC) today reported financial results for the first quarter ended March
31, 2013.

"In the first quarter, we generated initial commercial sales of PIXUVRI^® in
countries in the European Union where there is market access pending the
completion of the reimbursement process," said James Bianco, M.D., President
and CEO of CTI. "Although it is early in the launch, we are pleased with the
interest and receptivity of PIXUVRI by key lymphoma opinion leaders who treat
patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin
lymphoma (NHL) and who recognize the significant unmet need that exists for
these patients. In addition, our Phase 3 PERSIST-1 clinical trial of
pacritinib, an oral, once-daily JAK2/FLT3 inhibitor, in myelofibrosis
continues to progress with the opening of additional sites and growing
enrollment."

First Quarter and Recent Highlights

European Union (E.U.) Commercial

  oInitiated commercial sales of PIXUVRI^® (pixantrone) as a monotherapy for
    the treatment of adult patients with multiply relapsed or refractory
    aggressiveB-cell NHL during the first quarter of 2013. CTI is pursuing
    pricing and reimbursement for PIXUVRI in France, Germany, Italy, Spain and
    the United Kingdom (UK).

Research and Development

  oInitiated patient enrollment in PERSIST-1, which is the first of two
    planned investigational Phase 3 studies of pacritinib in patients with
    myelofibrosis. PERSIST-1 is a randomized trial that is expected to enroll
    270 patients in Europe, Australia, Russia and the U.S. and is designed to
    evaluate the safety and efficacy of pacritinib compared to best available
    therapy, excluding JAK inhibitors, in patients with myelofibrosis. A
    second Phase 3 trial is planned to initiate in the second half of 2013.
  oAnnounced that results from the OPAL Phase 2 study of tosedostat in
    elderly patients with relapsed or refractory acute myeloid leukemia (AML)
    were published in Lancet Oncology. Tosedostat is an oral aminopeptidase
    inhibitor which has been shown to deprive tumor cells of the amino acid
    building blocks they need to make proteins necessary for tumor cell
    survival. A Phase 2 investigator-sponsored trial of tosedostat in
    combination with standard agents in the treatment of patients with AML and
    myelodysplastic syndrome is ongoing.

Corporate

  oEntered into a senior secured term loan of up to $15.0 million. The first
    $10 million of the term loan was funded at closing. The proceeds from this
    loan facility are expected to provide CTI with additional operating
    capital to advance our Phase 3 clinical development programs.

First Quarter 2013 Financial Results 

Total revenues for the first quarter of 2013 were $1.1 million. The revenues
were solely attributable to net product sales of PIXUVRI. CTI sells PIXUVRI
directly to health care providers and through a limited number of wholesale
distributors in the E.U.CTI records product sales upon receipt of the product
by the health care provider or distributor. Product sales are recorded net of
estimated distributor discounts, government-mandated discounts and rebates,
and estimated product returns.

Total operating expenses for the first quarter of 2013 were $19.6 million,
compared to $18.1 million for the same period in 2012. Total operating
expenses included$2.4 millionand$2.0 millionof non-cash stock-based
compensation expense in the first quarters of 2013 and 2012, respectively. The
net loss for the first quarter of 2013 was $19.4 million, or ($0.18) per
share, compared to a net loss of $17.4 million, or ($0.43) per share, for the
same period in 2012.

As of March 31, 2013, CTI's cash and cash equivalents totaled $44.3 million.

Financial Guidance for 2013

CTI reaffirms prior financial guidance that, for 2013, loss from operations is
expected to be approximately $60 to $65 million, excluding non-cash
stock-based compensation expense.

Actual financial results for 2013 will vary based upon many factors, including
the growth of PIXUVRI sales and determination of reimbursement rates for
PIXUVRI in the E.U., the rate of patient enrollment in pacritinib clinical
trials that are ongoing and planned for initiation in 2013 and other factors
described in our filings with the SEC.

Conference Call Information

CTI management will host a conference call to review its first quarter 2013
financial results and provide an update on business activities. The event will
be held today at1:30 p.m.PDT / 4:30 p.m.EDT/ 10:30 p.m. CET. Participants
can access the call at 1-877-941-6010 (domestic) or +1 480- 629-9644
(international). To access the live audio webcast or the subsequent archived
recording, visit CTI's website, www.celltherapeutics.com. Webcast and
telephone replays of the conference call will be available at approximately
two hours after completion of the call. Callers can access the replay by
dialing 1-800-358-3474 (domestic) or +1 303-590-3030 (international). The
access code for the replay is 4603217#. The telephone replay will be available
untilThursday, May 9, 2013.

About Cell Therapeutics, Inc.

Cell Therapeutics (NASDAQ and MTA: CTIC) is a biopharmaceutical company
committed to the development and commercialization of an integrated portfolio
of oncology products aimed at making cancer more treatable. CTI is
headquartered in Seattle, WA. For additional information and to sign up for
email alerts and get RSS feeds, please visit the company's website at
www.CellTherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements about future financial
results, anticipated clinical study enrollment and timing, and other
forward-looking information 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 or tosedostat include
risks associated with preclinical and clinical developments in the
biopharmaceutical industry in general and with PIXUVRI, pacritinib or
tosedostat in particular including, without limitation, the potential failure
of PIXUVRI to prove safe and effective for the treatment of relapsed or
refractorynon-Hodgkin lymphoma (NHL) and/or other tumors as determined by
theU.S. Food and Drug Administration (FDA); that CTI's plan to make PIXUVRI
commercially available in additional countries inEurope may not occur as
planned and that CTI's sales of PIXUVRI may not occur as planned; that CTI may
not secure pricing and reimbursement for PIXUVRI in France, Germany, Italy,
Spain and the United Kingdom 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 byJune 2015or at all as required by the European
Medicines Agency (EMA); that CTI may not have the results of the PIX306
clinical trial available byJune 2015or 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; that CTI may not complete patient accrual in the
PERSIST-1 Phase 3 trial of pacritinib for the treatment of patients with
myelofibrosis in 2013 or early 2014; the potential that the second Phase 3
study of pacritinib might not begin in the second half of 2013; that
pacritinib may not prove safe and effective for primary myelofibrosis and
myelofibrosis secondary to other myeloproliferative neoplasms; the potential
that Phase 3 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 acute myeloid leukemia or high-risk
myelodysplastic syndrome (including when administered in combination with
cytarabine or decitabine) as determined by theFDAand/or the EMA; that the
studies of tosedostat may not achieve their primary and/or secondary
objectives; that tosedostat may not be approved by the FDAand/or the EMA;
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; the risk that CTI may not be
able to draw-down additional funds from the loan facility; 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
theSecurities and Exchange Commissionincluding, without limitation, CTI's
most recent filings on Forms 10-K, 10-Q and 8-K. 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 and Investor Contacts:

Cell Therapeutics, Inc.

Monique Greer
+1 206.272.4343
mgreer@ctiseattle.com

Ed Bell
+1 206.272.4345
invest@ctiseattle.com

In Europe

CTI Life Sciences Limited, Milan Branch

Laura Villa
Elena Bellacicca

E: CTI_EUInvestors@CTI-Lifesciences.com
T: +39 02 89659700
F: +39 02 89659719
http://www.celltherapeutics.com/italiano





Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
(unaudited)
                                           Three Months Ended
                                           March 31,
                                           2013           2012
Revenues:
 Product sales, net                        $   1,126    $         
                                                          -
 Total revenues                            1,126          -
Operating costs and expenses:
 Cost of product sold                      55             -
 Research and development                  8,355          8,170
 Selling, general and administrative       11,143         9,928
 Total operating expenses                  19,553         18,098
Loss from operations                       (18,427)       (18,098)
Other income (expense):
 Investment and other income (expense),    (367)          190
 net
 Interest expense                          (48)           (5)
 Amortization of debt discount and         (23)           -
 issuance costs
 Foreign exchange gain (loss)              (751)          384
Net loss before noncontrolling interest    (19,616)       (17,529)
 Noncontrolling interest                   232            83
Net loss                                  $ (19,384)     $    (17,446)
Basic and diluted net loss per common      $   (0.18)  $       (0.43)
share
Shares used in calculation of basic and
diluted
net loss per common share                  106,697        40,792
Balance Sheet Data (unaudited):            (amounts in thousands)
                                           March 31,      December 31,
                                           2013           2012
Cash and cash equivalents                 $ 44,314      $     50,436
Working capital                            30,051         37,644
Total assets                               65,267         73,713
Long-term debt                             8,066          -
Total shareholders' equity                 16,100         32,944

SOURCE Cell Therapeutics, Inc.

Website: http://www.celltherapeutics.com
 
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