Cyclacel Pharmaceuticals reports net loss of $5.1M for first-quarter 2010

Cyclacel Pharmaceuticals, Inc.May 14 2010

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today reported its financial results and business highlights for the first quarter ended March 31, 2010. The net loss for the first quarter was $5.1 million, or $0.18 per basic and diluted share. This compared to a net loss of $5.1 million, or $0.26 per basic and diluted share, for the same period in 2009. As of March 31, 2010, cash and cash equivalents totaled $24.2 million.

"We made important progress during the quarter in advancing the development of sapacitabine, our lead product candidate," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We submitted to FDA a Special Protocol Assessment (SPA) request for a randomized Phase 3 study of sapacitabine in elderly patients with acute myeloid leukemia (AML). The FDA has reviewed our proposed Phase 3 protocol and statistical analysis plan. Following consultations with the FDA, we expect to receive action on the SPA in the near future. Looking to the rest of the year in our sapacitabine program, we are preparing to initiate the Phase 3 study in AML, planning to report Phase 2 data in MDS and progressing our Phase 2 study in lung cancer. We are also continuing to evaluate the broad therapeutic utility of our cyclin-dependent kinase (CDK) inhibitor drug candidates in treating cancers that are resistant to available therapies."

First Quarter 2010 and Recent Highlights

• SPA submission for a randomized Phase 3 study of sapacitabine in elderly patients with AML
• Publication of peer-reviewed journal articles demonstrating non-clinical activity with Cyclacel's seliciclib and its analogue CYC065 in resistant cancers, including lung cancer with Ras mutations, such as K-RAS and N-RAS, and breast cancer resistant to letrozole or trastuzumab
• Presented six abstracts at the American Association for Cancer Research annual meeting, including data on sapacitabine, seliciclib, CYC065, a second-generation CDK inhibitor, and Polo-like kinase 1 (Plk1) inhibitors, highlighting Cyclacel's innovative and diverse oncology pipeline
• Raised $18.5 million in registered offerings and warrant exercises
• Regained compliance with the minimum $50 million market value of listed securities requirement for continued listing on The NASDAQ Global Market

"Recently published data demonstrated that seliciclib and CYC065 have activity in resistant lung cancer cell lines with Ras mutations. Building on these findings, we plan to test tissue samples from patients treated with seliciclib for Ras mutations. We were recently encouraged to learn that a cancer patient in one of our seliciclib studies who experienced prolonged stable disease of over a year while on seliciclib treatment was subsequently confirmed to have the K-RAS mutation," added Mr. Rombotis. "Cyclacel and its collaborating scientists and physicians are intrigued by these early results and continue to explore the activity of CDK inhibitors in the setting of resistant cancers."

Future Milestones

• FDA action regarding the SPA for the Phase 3 study of sapacitabine in elderly patients with AML
• Initiation of Phase 3 study of sapacitabine in elderly patients with AML
• Report myelodysplastic syndromes (MDS) interim Phase 2 data with sapacitabine at the American Society of Clinical Oncology (ASCO) annual meeting
• Report non-small cell lung cancer (NSCLC) interim Phase 2 data with sapacitabine and
• Report top line results from APPRAISE NSCLC Phase 2b trial with seliciclib

First Quarter 2010 Financial Results

Revenues for the quarter were $0.3 million, compared to $0.2 million for the same period in 2009.  Cyclacel's product revenues were comprised of sales of Xclair® Cream for radiation dermatitis and Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia.

The operating loss for the quarter was $4.5 million compared to $5.2 million for the same period in 2009.  Cyclacel reported a net loss of $5.1 million, or $0.18 per share for the first quarter of 2010, compared to a net loss of $5.1 million, or $0.26 per share for the same period in 2009.

Research and development expenses in the first quarter of 2010 were $2.2 million compared to $3.1 million for the same period in 2009.  The $0.9 million decrease was primarily the result of focusing activities on our lead drug candidate, sapacitabine.  Total selling, general and administrative expenses for the first quarter of 2010 were $2.4 million, compared to $2.2 million for the same period in 2009 with the $0.2 million increase primarily related to increased spending on professional costs.

As of March 31, 2010, Cyclacel's cash and cash equivalents were $24.2 million compared to $11.5 million as of December 31, 2009. The Company raised $18.5 million through registered offerings and warrant exercises in this first quarter which resulted in higher cash and cash equivalents balances. The Company expects its existing capital resources should be adequate to fund operations and commitments into 2012.