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Cyclacel Pharmaceuticals Reports Fourth Quarter And Full Year 2012 Financial Results

Fourth Quarter 2012 and Recent Highlights

Sapacitabine in Acute Myeloid Leukemia
  • Randomized as of today 162 patients or approximately 33% of the projected number of patients in SEAMLESS.
  • Convened the second meeting of the independent Data Safety Monitoring Board (DSMB) of the SEAMLESS, Phase 3, randomized, registration-directed study of sapacitabine in elderly patients with AML. The DSMB recommended that the study should continue as planned after reviewing available data from 119 randomized patients. The DSMB noted that no safety or efficacy concerns were identified. SEAMLESS is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The DMSB will conduct additional periodic reviews and will perform a futility assessment once 212 events are observed.
  • Pooled updated survival data from the Phase 1/2 pilot study and the lead-in phase of SEAMLESS evaluating the sequential regimen of sapacitabine and decitabine were presented at the 54th American Society of Hematology conference. The data demonstrated median overall survival of 238 days, or approximately 8 months. Forty-six patients with a median age of 77 years (range 70-90) were treated with alternating cycles of sapacitabine and decitabine. Thirty-three patients (72%) were 75 years or older. Sixteen patients (35%) survived 1 year or longer. The number of patients alive at 3 months was 38 (83%), 6 months 30 (65%), 12 months 16 (35%) and 18 months 12 (26%). Among 33 patients (72%) who are 75 years or older, median overall survival was 263 days, or approximately 9 months, and 1-year survival was 36%.
  • Results published in The Lancet Oncology showed promising response rate and overall survival observed in elderly patients aged 70 years or older with newly diagnosed AML or AML in first relapse enrolled in a Phase 2 study of single-agent sapacitabine.

Sapacitabine in Myelodysplastic Syndromes
  • Reported results at The Eighth Annual Hematologic Malignancies 2012 Conference from the Phase 2 randomized trial of sapacitabine in older patients with intermediate-2 or high-risk MDS after treatment failure of front-line hypomethylating (HMA) agents, such as azacitidine and/or decitabine. The data showed that sapacitabine nearly doubled expected survival in this population. The study enrolled 63 patients aged 60 years or older with intermediate-2 or high-risk MDS. Median overall survival for all patients in the three arms was 252 days (approximately 8 months). Median overall survival for 41 of 63 patients with 10% to 19% blasts in their bone marrow was 274 days or approximately 9 months. Twenty-two percent of patients were still alive.

Sapacitabine in Solid Tumors
  • Reported at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting interim data from an open label, single arm, Phase 1 escalation trial of sapacitabine, in combination with seliciclib, Cyclacel's CDK inhibitor, as an orally-administered sequential treatment regimen in heavily-pretreated patients with advanced solid tumors. The regimen showed early evidence of antitumor activity in particular in cancer patients found to be carriers of BRCA mutations.

Other highlights
  • The personalized medicine potential of sapacitabine was presented at the 8th National Cancer Research Institute Cancer Conference. Translational findings demonstrated the potential for sapacitabine to be used alone or in combination to treat homologous recombination repair (HRR) defective tumors, such as cancers with ATM or BRCA defects.
  • Issued U.S. Patent 8,349,792 and European Patent 2,101,790. Both patents include claims to combination treatment of sapacitabine with HDAC (histone deacetylase) inhibitors. The patents provide exclusivity until June 2029 and December 2027 respectively. The patents include claims to combinations of sapacitabine and HDAC inhibitors, pharmaceutical compositions comprising sapacitabine and HDAC inhibitors, and methods of treating various cancers including leukemias, lymphomas and lung cancer with such compositions.
  • Issued U.S. Patent 8,124,593 which grants claims to a specified method of administration of sapacitabine with certain claims supporting market exclusivity to 2030 adding to existing composition of matter patents.
  • Received a grant award of approximately $1.9 million from the UK Government's Biomedical Catalyst to complete investigational new drug (IND)-directed preclinical development of CYC065, a novel, orally available, second generation, CDK inhibitor.
  • Entered into a common stock purchase agreement with Aspire Capital Fund, LLC (Aspire). Aspire committed to purchase up to $20 million of Cyclacel's common stock from time to time as directed by Cyclacel over two years at formula prices based on the market price at the time of each sale.
  • Entered into separate Securities Exchange Agreements with two stockholders pursuant to which the Company issued an aggregate 748,455 shares of its common stock to the stockholders in exchange for delivery to the Company of an aggregate 417,003 shares of the Company's 6% Exchangeable Convertible Preferred Stock.
  • Issued a court order on March 6, 2013 by the United States District Court for the District of Delaware ordering a Stipulation and Order For Stay as to all pending dates on the court's calendar for a period of thirty (30) days in the pending litigation between Cyclacel Pharmaceuticals, Inc. and Celgene Corporation regarding four of the Company's patents claiming the use of romidepsin injection in T-cell lymphomas and Celgene's use and administration of its ISTODAX® (romidepsin for injection) product. The stay relates to all proceedings, including the 'Markman' (or claim construction) hearing previously scheduled for March 14, 2013.

Cyclacel's Key Milestones for 2013
  • Continue enrollment in the SEAMLESS pivotal, Phase 3 study in AML;
  • Report upcoming DSMB reviews of SEAMLESS;
  • Report Phase 2, updated survival data for sapacitabine in MDS following treatment failure of hypomethylating agents;
  • Announce registration-directed, clinical development plan for sapacitabine in MDS following treatment failure of hypomethylating agents;
  • Report updated Phase 1 sapacitabine and seliciclib combination data in patients with solid tumors;
  • Report outcome of 'Markman' patent construction hearing on romidepsin intellectual property litigation.

Financial Highlights

For the fourth quarter of 2012, Cyclacel reported a net loss applicable to common stockholders of $4.9 million, or $0.59 per basic and diluted share, compared to a net loss applicable to common stockholders of $3.8 million, or $0.50 per basic and diluted share, for the fourth quarter of 2011. Total research and development (R&D) expenses in the fourth quarter of 2012 were $2.0 million compared to $2.2 million in the fourth quarter of 2011. Total general and administrative expenses (G&A) amounted to $2.7 million in the fourth quarter of 2012 compared to $1.4 million for the fourth quarter of 2011. The increase is primarily due to an increase in legal, consultancy and other professional costs and reduced stock-based compensation costs. Total other expense was $0.4 million in the fourth quarter of 2012, which was primarily due to a non-cash consideration related to the stock purchase agreement with Aspire, compared to no expense in 2011.

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