SEATTLE, Nov. 7 Cell Therapeutics, Inc. (CTI)(Nasdaq and MTA: CTIC) reported financial results for the quarter endedSeptember 30, 2008. Total revenues for the quarter were $2.6 million comparedto $20,000 for the third quarter of 2007 due primarily to sales of Zevalin(R)(Ibritumomab Tiuxetan), a commercial radiopharmaceutical that CTI acquired inDecember 2007. Net product sales of Zevalin totaled $2.6 million in the thirdquarter of 2008. The Company also reported a significant decrease in operatingexpenses compared to the same period in 2007.
"We continue to make significant progress on the commercial front with thesubmission for a label expansion of Zevalin in September and our plan toreport top-line results from the pixantrone pivotal trial in November, whichif positive, would lead to us submitting an NDA in 2009," said James A.Bianco, M.D., CEO of CTI. "Importantly, we have made this progress whilekeeping in line with our strategy of reducing our expenses. Our net cash usedfor operating activities in the third quarter averaged approximately$5.75 million per month, a decrease of 27% from last quarter, and we are ontarget to reach our goal of $4.5 million per month in ongoing operatingexpenses in 2009."
-- Submitted supplemental Biologics License Application to the U.S. Foodand Drug Administration (FDA) in September for use of Zevalin as consolidationtherapy after remission induction in previously untreated patients withfollicular non-Hodgkin's lymphoma based on First-line Indolent Trial data.
-- Announced that CTI has closed the data set for preliminary analysis ofthe primary endpoint in the phase III EXTEND (PIX301) trial of pixantrone(BBR2778) for patients with relapsed diffuse large B cell non-Hodgkin'slymphoma (NHL) and anticipates reporting top-line results in November.
-- Announced that Christina Waters, Ph.D. most recently President and COOof Tyr Pharma and formerly Director of Scientific Development at GenomicsInstitute of the Novartis Research Foundation, has been named President of CTIEurope and CTI's Systems Medicine subsidiary.
Total operating expenses decreased $28.5 million, or 58 percent, to$20.5 million for the quarter ended September 30, 2008 compared to$49.0 million for the same period in 2007 mainly as a result of decreasedresearch and development expenses in the third quarter of 2008 and a one-timenon-cash charge for the acquisition of Systems Medicine recorded in the thirdquarter of 2007. Research and development costs decreased $7.2 million, or39 percent, to $11.3 million for the current quarter compared to $18.6 millionfor the same period in 2007 as the result of our cost reduction initiativesand expenses related to our clinical trial programs. Net loss attributable tocommon shareholders decreased to $47.6 million ($2.83 per share) for thequarter ended September 30, 2008, compared to $52.6 million ($10.91 per share)for the comparable period in 2007.
The Company had approximately $11.7 million in cash and cash equivalents,securities available-for-sale, and interest receivable as ofSeptember 30, 2008. This does not include $29.4 million in restricted cashheld in escrow for future make-whole and interest payments on our 9%, 15%,15.5% and 18.33% convertible senior notes. It also does not include netproceeds, before fees and expenses, of approximately $7.5 million from thepurchase of 9.66% Convertible Senior Notes due 2011 by a single investor inOctober 2008. Even with this additional financing, the Company will need toraise additional capital this year and is exploring alternatives to do so,which may include potential partnerships or joint ventures, public or privateequity financings, debt financings or restructurings, dispositions of assetsor through other means in order to fund its continued operations.
Conference Call Information
On Friday, November 7, 2008, at 8:30 a.m. Eastern/2:30 p.m. CentralEuropean/5:30 a.m. Pacific members of Cell Therapeutics, Inc.'s (CTI)(Nasdaq and MTA: CTIC) management team will host a quarterly conference callto discuss the Company's 2008 third quarter achievements and financialresults.
Live audio webcast at http://www.celltherapeutics.com will be archived forpost listening approximately two hours after call ends.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed todeveloping an integrated portfolio of oncology products aimed at making cancermore treatable. For additional information, please visithttp://www.CellTherapeutics.com.
This press release includes forward-looking statements about ourcommercial progress, potential regulatory filings, expected timing ofclinical trial results as well as efforts to reduce operating expenses, thatinvolve a number of risks and uncertainties, the outcome of which couldmaterially and/or adversely affect actual future results. Specifically, therisks and uncertainties include statements about future sales of Zevalin,including the risk that the data from the FIT trial may not prove adequate tosupport an approval of an sBLA for label expansion of that product, thepreliminary results we expect to report on our phase III pivotal trial ofpixantrone later this month may not be positive, our ability to continue toreduce our operating expenses, the Company's ability to continue to raisecapital as needed to fund its operations, the outcome of our pending hearingbefore a Nasdaq Listing Qualifications Panel as a result of our continuednon-compliance with Nasdaq's quantitative requirements to remain listed, thedevelopment of OPAXIO, pixantrone, and brostallicin, which include risksassociated with preclinical and clinical developments in the biopharmaceuticalindustry in general and with OPAXIO, pixantrone, and brostallicin inparticular, including, without limitation, the potential failure of theseproduct candidates to prove safe and effective for treatment of non-small celllung cancer, ovarian cancer, non-Hodgkin's lymphoma, and sarcoma,determinations by regulatory, patent and administrative governmentalauthorities, competitive factors, technological developments, costs ofdeveloping, producing and selling Zevalin, OPAXIO, pixantrone, andbrostallicin, and the risk factors listed or described from time to time inthe Company's filings with the Securities and Exchange Commission including,without limitation, the Company's most recent filings on Forms 10-K, 8-K, and10-Q. Except as may be required by law, CTI does not intend to update or alterits forward-looking statements whether as a result of new information, futureevents, or otherwise.Conference Call Numbers Friday, November 7 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time 1-877-835-3299 (US Participants) 1-303-262-2078 (International) Call-back numbers for post-listening available at 11:30 a.m. Eastern: 1-800-405-2236 (US Participants) 1-303-590-3000 (International) Passcode: 11121525#
SOURCE Cell Therapeutics, Inc.