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Cell Therapeutics Reports Third Quarter 2013 Financial Results

        Cell Therapeutics Reports Third Quarter 2013 Financial Results

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

PR Newswire

SEATTLE, Oct. 30, 2013

SEATTLE, Oct. 30, 2013 /PRNewswire/ -- Cell Therapeutics, Inc.(CTI) (NASDAQ
and MTA: CTIC) today reported financial results for the third quarter and nine
months ended September 30, 2013.

"We recently achieved an important clinical milestone in our pacritinib
development program, having reached agreement with the FDA on a Special
Protocol Assessment (SPA) for the planned pivotal Phase 3 PERSIST-2 clinical
trial of pacritinib for patients with myelofibrosis who have low platelet
counts," said James Bianco, M.D., President and CEO of CTI. "With the SPA in
place, we expect to initiate this trial in the fourth quarter of 2013 and
anticipate completing enrollment in approximately 12 months. We continue to
make progress with the reimbursement process for PIXVURI in the European Union
and are focused on educating physicians on the unmet medical need and building
brand awareness for PIXUVRI as a third- and fourth-line treatment option among
physicians in countries where PIXUVRI is currently available."

Third Quarter 2013 and Recent Highlights

PIXUVRI^® (pixantrone) Commercial: Market Access Granted in France and Italy

  oReported that the Company was granted market access by the Transparency
    Commission of the French National Health Authority in France and by the
    Italian Medicines Agency (AIFA) in Italy for PIXUVRI as a monotherapy for
    the treatment of adult patients with multiply relapsed or refractory
    aggressive B-cell NHL (patients with aggressive B-cell NHL who failed 2 or
    3 prior lines of therapy).

Research and Development: Reached SPA Agreement with FDA for PERSIST-2
Clinical Trial

  oReached agreement with the U.S. Food and Drug Administration (FDA) on a
    SPA for the planned pivotal Phase 3 clinical trial, known as PERSIST-2,
    evaluating pacritinib compared to best available therapy, including
    approved JAK2 inhibitors such as ruxolitinib, in patients with
    myelofibrosis whose platelet counts are <100,000/uL. The PERSIST-2 trial
    is the second of two planned Phase 3 clinical trials of pacritinib in
    patients with myelofibrosis. CTI expects to initiate PERSIST-2 in the
    fourth quarter of 2013.

Corporate: Expanded CTI's Scientific Advisory Board and Raised Approximately
$15 million in Financing.

  oAdded three leaders in the research and development of new treatments for
    blood-related cancers to CTI's recently formedScientific Advisory
    Board(SAB):Alan List, M.D., President and CEO ofMoffitt Cancer
    Center;Ross Levine, M.D., Associate Attending Physician atMemorial
    Sloan-Kettering Cancer Center; andBrian Druker, M.D., Director of
    theKnight Cancer InstituteatOregon Health & Science University. CTI's
    SAB is chaired by Daniel Von Hoff, M.D., F.A.C.P.
  oCompleted registered direct offering without an underwriter or placement
    agent for net proceeds of approximately$14.8 million.

Third Quarter 2013 Financial Results

Total revenues for the third quarter and the nine months ended September 30,
2013 were $0.4 million and $1.8 million, respectively. 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 generally records product sales upon receipt of
the product by the health care provider or distributor, net of distributor
discounts, estimated government-mandated discounts and rebates, and estimated
product returns. Any future revenues are dependent on market acceptance of
PIXUVRI, the reimbursement decisions made by governmental authorities in each
country where PIXUVRI is available for sale and other factors.

Loss from operations for the third quarter of 2013 was $15.6 million, compared
to $15.1 million for the same period in 2012. For the first nine months of
2013, loss from operations was $51.9 million compared to $82.6 million for the
same period in 2012. The amount recorded for the nine months ended September
30, 2012 included a $29.1millionexpense for acquired in-process research and
development related to the acquisition of pacritinib from S*BIO Pte Ltd.
Non-cash, share-based compensation expense for the third quarter and first
nine months of 2013 was $1.9 million and $6.3 million, respectively, compared
to $1.0 million and $6.1 million for the same periods in 2012.

The net loss for the third quarter of 2013 was $22.4 million, or ($0.20) per
share, compared to $20.2 million, or ($0.38) per share, for the same period in
2012. For the first nine months of 2013, net loss was $59.8 million, or
($0.55) per share, compared to $96.2 million, or ($2.12), per share for the
same period in 2012.

As of September 30, 2013, CTI's cash and cash equivalents totaled $27.2
million.

Financial Guidance for 2013

CTI reaffirms prior financial guidance that, for 2013, loss from operations
excluding non-cash, share-based compensation expense, which is a non-GAAP
measure, is expected to be approximately $60 to $65 million. Year-to-date for
the nine month period ended September 30, 2013, loss from operations,
excluding non-cash share-based compensation expense, which is a non-GAAP
measure, was $45.5 million. For more information regarding CTI's use of these
non-GAAP measures and a reconciliation of non-GAAP loss from operations
excluding non-cash share-based compensation expense to loss from operations
for the nine months ended September 30, 2013, please refer to the section
below entitled "Non-GAAP Financial Measures".

Actual financial results for 2013 will vary based upon many factors, including
the degree of market acceptance 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 Securities and Exchange Commission.

Conference Call Information

CTI management will host a conference call to review its third 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/ 9:30 p.m. CET.
Participants can access the call at 1-866-225-8754 (domestic) or +1
480-629-9819 (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 1-800-406-7325 (domestic) or +1 303-590-3030
(international). The access code for the replay is 4647208#. The telephone
replay will be available untilWednesday, November 6, 2013.

About Cell Therapeutics, Inc.

Cell Therapeutics (NASDAQ and MTA: CTIC) is a biopharmaceutical company
focused on the acquisition, development, and commercialization of less toxic
and more effective ways to treat cancer. CTI is headquartered in Seattle, WA.
For additional information and to sign up for email alerts and get RSS feeds,
please visit www.CellTherapeutics.com.

Non-GAAP Financial Measures

CTI has provided in this press release the historical financial measure of
loss from operations, excluding share-based compensation expense, which is a
non-GAAP measure, for the nine months ended September 30, 2013, and the
financial projection of loss from operations, excluding share-based
compensation expense, which is a non-GAAP measure, for the 2013 fiscal year.
Due to varying available valuation methodologies, subjective assumptions and
the different GAAP accounting treatment of different award types that
companies can use under ASC Topic 718, CTI's management believes that
providing a non-GAAP financial measure that excludes share-based compensation
can enhance management's and investors' comparison of CTI's operating results
over different periods of time as compared to the operating results of other
companies.

Our use of a non-GAAP financial measure has limitations and should not be
considered in isolation from, or as a substitute for, financial information
prepared in accordance with GAAP. Our reported non-GAAP loss from operations
results in the exclusion of a recurring expense, since share-based
compensation will continue to be a significant recurring expense in CTI's
business. Second, our methodology for calculating non-GAAP loss from
operations, which only excludes the component of share-based compensation, may
differ from the methodology our peer companies utilize to the extent they
report non-GAAP loss from operations or similarly titled measures and
accordingly may not necessarily be comparable to similarly titled measures of
other companies. Investors are urged 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.

CTI has not included a reconciliation of our projected non-GAAP loss from
operations to a projected GAAP loss from operations because the calculation of
the excluded share-based compensation would require information that is
presently uncertain, such as the future level of additional equity awards that
will be granted to meet CTI's compensation philosophy and objectives after
taking into account the economic climate at the time of grant. In addition,
the calculation is largely based on the price of CTI's stock at the time of
the specific grants (as required under ASC Topic 718), which price is variable
and therefore unknowable until the grant is made. Because of the contingent
nature of such factors, CTI believes that the specific adjustment for future
share-based compensation cannot be forecast with accuracy.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of
the Safe Harbor provisions of the Private Securities Litigation Reform Act of
1995. Such statements are subject to a number of risks and uncertainties, the
outcome of which could materially and/or adversely affect actual future
results and the trading price of CTI's securities. Such statements include,
but are not limited to, statements regarding CTI's expectations with respect
to the development of CTI and its product and product candidate portfolio,
the enrollment for and timing of the PERSIST-2 trial of pacritinib, and CTI's
financial guidance for 2013. Risks that contribute to the uncertain nature of
the forward-looking statements include, among others, risks associated with
the biopharmaceutical industry in general and with CTI and its product and
product candidate portfolio in particular including, among others, risks
associated with the following: that CTI cannot predict or guarantee the pace
or geography of enrollment of its clinical trials; that CTI cannot predict or
guarantee the outcome of preclinical and clinical studies; that CTI may not
obtain reimbursement for PIXUVRI in certain markets in the E.U. as planned or
at all; that the conditional marketing authorization for PIXUVRI may not be
renewed or may be subject to additional conditions; that the PERSIST-2 trial
of pacritinib will not occur as planned or at all; that CTI may not obtain
favorable determinations by other regulatory, patent and administrative
governmental authorities; that CTI may experience delays in the commencement
of preclinical and clinical studies; risks related to the costs of developing,
producing and selling PIXUVRI, pacritinib, and CTI's other product candidates;
and other risks, including, without limitation, competitive factors,
technological developments, that CTI's operating expenses continue to exceed
its net revenues, that CTI may not be able to sustain its current cost
controls or further reduce its operating expenses, that CTI may not achieve
previously announced goals and objectives as or when projected, that CTI's
average net operating burn rate may increase, that CTI will continue to need
to raise capital to fund its operating expenses, but may not be able to raise
sufficient amounts to fund its continued operation, as well as other risks
listed or described from time to time in CTI's most recent filings with the
Securities and Exchange Commission on Forms 10-K, 10-Q and 8-K. Except as
required by law, CTI does not intend to update any of the statements in this
press release upon further developments.

PIXUVRI is a registered trademark of Cell Therapeutics, Inc.

Contacts:

Monique Greer
+1 206-272-4343
mgreer@ctiseattle.com

Ed Bell
+1 206-282-7100
ebell@ctiseattle.com

In Europe:

CTI Life Sciences Limited, Milan Branch
Laura Villa
+39 02 89659706
lvilla@cti-lifesciences.com
CTI_EUInvestors@CTI-Lifesciences.com



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,
                            2013        2012          2013         2012
Revenues:
   Product sales, net       $        $        $       $     
                            362        -            1,794           -
       Total revenues       362         -             1,794        -
Operating costs and
expenses:
   Cost of product sold     13          -             104          -
   Research and             7,245       6,951         23,620       24,080
   development
   Selling, general and     8,529       7,763         29,774       29,024
   administrative
   Acquired in-process
   research and             -           -             -            29,108
   development
   Settlement expense       155         435           155          435
       Total operating      15,942      15,149        53,653       82,647
       costs and expenses
Loss from operations        (15,580)    (15,149)      (51,859)     (82,647)
Other income (expense):
   Investment and other     (173)       (270)         (433)        (179)
   income (expense), net
   Interest expense         (316)       (43)          (680)        (51)
   Amortization of debt
   discount and issuance    (162)       -             (349)        -
   costs
   Foreign exchange gain    547         216           (199)        (96)
   (loss)
Net loss before             (15,684)    (15,246)      (53,520)     (82,973)
noncontrolling interest
   Noncontrolling interest  140         57            581          200
Net loss attributable to    (15,544)    (15,189)      (52,939)     (82,773)
CTI
   Deemed dividends on      (6,900)     (5,014)       (6,900)      (13,472)
   preferred stock
Net loss attributable to    $ (22,444)  $ (20,203)    $         $   
CTI common shareholders                               (59,839)    (96,245)
Basic and diluted net loss  $         $           $       $     
per common share           (0.20)      (0.38)        (0.55)      (2.12)
Shares used in calculation
of basic and diluted net    110,996     52,921        108,489      45,442
loss per common share
Balance Sheet Data                                    (amounts in thousands)
(unaudited):
                                                      September    December
                                                      30,          31,
                                                      2013         2012
Cash and cash equivalents                            $        $    
                                                      27,176       50,436
Working capital                                       13,217       37,644
Total assets                                          47,239       73,713
Current portion of                                    1,216        -
long-term debt
Long-term debt, less                                  7,126        -
current portion
Total shareholders' equity                            387          32,944



Non-GAAP Reconciliation
(In thousands)
(unaudited)
                                       Nine Months Ended September 30,
                                       2013
As reported - loss from operations     $                   
(GAAP)                                     (51,859)
As reported - share-based compensation $                   
expense (GAAP)                               6,324
As adjusted - loss from operations     $                   
(Non-GAAP)                                 (45,535)

SOURCE Cell Therapeutics, Inc.

Website: http://www.celltherapeutics.com