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Cell Therapeutics, Inc. (CTIC) (CTI) Readies Pixuvri® European Launch and Start of Pacritinib Phase 3 Trial; Reports Second Quarter Financial Results and Milestones


8/1/2012 10:03:15 AM

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

Recent Company Highlights

  • European Commission grants conditional marketing authorization for Pixuvri as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas ("NHL")
  • Steven E. Benner, M.D., M.H.S. named new Executive Vice President and Chief Medical Officer
  • Closed the acquisition of pacritinib, a highly selective JAK2 inhibitor, scheduled to enter phase 3 clinical trial for treatment of patients with myelofibrosis ("MF") in Q4 2012
  • Targeting cut in net operating burn rate from an average of $6.5 million per month to an average of $4.5 million per month for remainder of 2012 and focusing on commercial launch of Pixuvri and advancing phase 3 programs

"Based on in-market research among more than 250 lymphoma specialists in the five major market countries in the European Union ("EU"), we are encouraged by the interest and potential adoption of Pixuvri for treatment," stated James A. Bianco, M.D., President and CEO of CTI. "We believe we can present an argument for Pixuvri to provide fair pricing reimbursement in an effort to address the commercial potential of Pixuvri in the E.U. On the heels of our projected fourth quarter launch of Pixuvri in the E.U., we expect to start pivotal studies of our recent JAK2 product acquisition, pacritinib. In the meantime, we are also advancing tosedostat toward its phase 3 clinical trial."

Financial Results

For the quarter ended June 30, 2012, total operating expenses were $49.4 million compared to $16.9 million for the same period in 2011. The increase is predominantly due to an acquired in-process research and development expense of $29.1 million relating primarily to the acquisition of pacritinib from S*BIO Pte Ltd. ("S*BIO"), in addition to equity-based compensation and expenses related to preparation for commercialization of Pixuvri in the E.U. Net loss attributable to common shareholders was $58.6 million ($0.28 per share) for the quarter ended June 30, 2012 compared to a net loss attributable to common shareholders of $22.5 million ($0.14 per share) for the same period in 2011. The increase in net loss attributable to CTI's common shareholders is primarily due to an increase in non-cash deemed dividends on preferred stock issuances and operating expenses, which includes the acquisition of pacritinib from S*BIO.

For the six months ended June 30, 2012, total operating expenses were $67.5 million compared to $37.0 million for the same period in 2011. Net loss attributable to common shareholders was $76.0 million ($0.37 per share) for the six months ended June 30, 2012 compared to a net loss attributable to common shareholders of $73.5 million ($0.47 per share) for the same period in 2011. The increase in net loss attributable to CTI's common shareholders is primarily due to an increase in total operating expenses, which includes the acquisition of pacritinib from S*BIO.

CTI had approximately $14.8 million in cash and cash equivalents as of June 30, 2012. This amount was before the receipt of $15 million in gross proceeds received from the sale of CTI's Series 15-2 convertible preferred stock and warrants in July 2012 as part of a $35 million financing. As previously announced, CTI completed the first closing of $20 million of Series 15-1 convertible preferred stock and warrants in May 2012.

Conference Call Information

On Aug. 1, 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 second quarter financial results.

Conference Call NumbersAug. 1, 2012, at 8:30 a.m. Eastern/2:30 p.m. Central European/5:30 a.m. Pacific Time 1-877-941-6010 (US Participants) 1-480- 629-9644 (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: 4552195 #

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 http://ec.europa.eu/health/documents/community-register/html/h764.htm#ProcList.

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 Non-Hodgkin Lymphoma. 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 in the United States, conditional marketing authorizations are granted in the E.U. to medicinal products with a positive benefit/risk assessment that 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 Bcell NHL 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 by June 2015.

About Non-Hodgkin's Lymphoma

NHL is caused by the abnormal proliferation of lymphocytes, cells key to the functioning of the immune system. It usually originates in lymph nodes and spreads through the lymphatic system. NHL can be broadly classified into two main formsaggressive and indolent NHL. Aggressive NHL is a rapidly growing form of the disease that moves into advanced stages much faster than indolent NHL, which progresses more slowly. The World Health Organization's International Agency for Research on Cancer's 2008 GLOBOCAN database most recent estimates state that in the E.U. approximately 74,162 people will be diagnosed with NHL and 31,371 are estimated to die from NHL every year.

There are many subtypes of NHL, but aggressive B cell NHL is the most common and accounts for about 60% of cases. Initial therapy for aggressive NHL with anthracycline-based combination therapy cures up to 60% of patients. Of the remaining patients, approximately half will respond to intensive second-line treatment and some are cured by stem cell transplantation. Of those not eligible for intensive second line therapy and those patients who fail to respond or relapse, until the approval of Pixuvri, no therapeutic has received regulatory approval for this patient group.

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.

About Tosedostat

Tosedostat is an oral, aminopeptidase inhibitor that has demonstrated significant anti-tumor responses in blood-related cancers and solid tumors in phase I-II clinical trials. CTI has exclusive marketing and co-development rights to Chroma Therapeutics Ltd.'s drug candidate tosedostat in North, Central, and South America

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.

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