SEATTLE, April 20, 2012 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI" or the "Company") (NASDAQ and MTA: CTIC) today reported financial results and recent accomplishments for the first quarter of 2012.
First Quarter Financial Results
For the quarter ended March 31, 2012, total operating expenses were $18.1 million compared to $20.1 million for the same period in 2011. Net loss attributable to common shareholders decreased 66% to $17.4 million ($0.09 per share) for the quarter ended March 31, 2012 compared to a net loss attributable to common shareholders of $51.0 million ($0.35 per 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 deemed dividends and total operating expenses. CTI had approximately $27.4 million in cash and cash equivalents as of March 31, 2012.
- In February 2012, the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") granted a positive opinion for conditional approval of CTI's MAA for Pixuvri as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma ("NHL").
- In April 2012, CTI entered into an agreement to acquire a highly selective JAK2 inhibitor, pacritinib, which is a phase 3 candidate for treating patients with myelofibrosis ("MF").
"With potential approval of our MAA for Pixuvri in the E.U. to treat adult patients with multiple relapsed or refractory aggressive B-cell non-Hodgkin lymphoma and tosedostat gearing up to initiate a pivotal phase 3 trial in relapsed or refractory acute myeloid leukemia/myelodysplastic syndromes ("MDS") later this year, the agreement to acquire pacritinib, a highly selective JAK2 inhibitor, rounds out our novel late stage oncology drug portfolio placing us in a select group of biotech companies. Our oncology drug portfolio now spans across a range of blood related cancers," stated James A. Bianco, M.D., CEO of CTI.
Conference Call Information
On Friday, April 20, 2012, 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 conference call to discuss CTI's 2012 first quarter financial results.
Conference Call Numbers
Friday, April 20, 2012 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time
1-800-762-8779 (US Participants)
Call-back numbers for post-listening available at 11:30 a.m. Eastern Time:
1-800-406-7325 (US Participants)
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 trading price of CTI's securities. Specifically, the risks and uncertainties that could affect the development of CTI's drug candidates include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with Pixuvri in particular, including, without limitation, the potential failure of Pixuvri to prove safe and effective for the treatment of relapsed or refractory aggressive B-cell NHL and/or other tumors as determined by the U.S. Food and Drug Administration (the "FDA") and/or the EMA, that Pixuvri may not be the first drug approved as monotherapy for the treatment of adult patients with multiple relapsed or refractory aggressive B-cell NHL, that the European Commission may not formally adopt the CHMP's recommendation regarding Pixuvri in the second quarter of 2012 or at all, that conditional approval of CTI's MAA for Pixuvri may not be granted by the European Commission in the second quarter of 2012 or at all, that Pixuvri may not be approved for marketing in all of the E.U. Member States and the European Economic Area members, that, even if the MAA for Pixuvri receives conditional approval, that the EMA may request additional information from CTI regarding Pixuvri, the potential failure of tosedostat to provide safe and effective for the treatment of patients with relapsed/refractory AML or MDS as determined by the FDA and/or the EMA, that the phase III clinical trial of tosedostat may not be initiated this year or as planned, the potential failure of pacritinib to prove safe and effective for the treatment of patients with MF as determined by the FDA and/or the EMA, that pacritinib may not satisfy a medical need not currently addressed with existing non-selective JAK1/JAK2 inhibitors, that pacritinib may not be differentiated due to its high target selectivity, that the acquisition of pacritinib may not be timely completed, if at all, that the projected benefits of the acquisition of pacritinib may not materialize as expected, that CTI may not be able to successfully implement its plans, strategies and objectives related to the acquisition and development of pacritinib, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI may not be able to sustain its current cost controls, and that CTI may not be able to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling its drug candidates. Further risks and uncertainties include CTI's operating expenses continue to exceed its net revenues, that CTI may not be able to further reduce its operating expenses, that CTI 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 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.
Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
Three Months Ended
Research and development
Selling, general and administrative
Total operating expenses
Loss from operations
Other income (expense):
Investment and other income, net
Amortization of debt discount and issuance costs
Foreign exchange gain
Net loss before noncontrolling interest
Net loss attributable to CTI
Dividends and deemed dividends on preferred stock
Net loss attributable to CTI common shareholders
Basic and diluted net loss per common share
Shares used in calculation of basic and diluted
net loss per common share
Balance Sheet Data (unaudited):
(amounts in thousands)
Cash and cash equivalents
Total shareholders' equity
SOURCE Cell Therapeutics, Inc.
Nasdaq quotes delayed at least 15 minutes, all others at least 20 minutes.
Markets are closed on certain holidays. Stock Market Holiday List
By accessing this page, you agree to the following
Press Release Service provided by PRConnect.
Stock quotes supplied by Telekurs USA
Postage Rates Bots go here