Full Press Release Details
CYCLACEL PHARMACEUTICALS REPORTS THIRD QUARTER 2010 FINANCIAL RESULTS
BERKELEY HEIGHTS, NJ November 11, 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 diseases, today reported its
financial results and business highlights for the third quarter of 2010.
Cyclacel reported a net loss applicable to common shareholders of $4.0 million, or $0.11 per share
for the third quarter of 2010, compared to a net loss applicable to common shareholders of $3.4
million, or $0.15 per share, for the same period in 2009. For the nine months ended September 30,
2010, Cyclacel reported a net loss applicable to common shareholders of $16.3 million, or $0.47 per
share, compared to a net loss applicable to common shareholders of $16.2 million, or $0.76 per
share in the same period in 2009.
During the quarter we have made important progress with regard to advancing sapacitabine oral
capsules into late stage development. We have reached agreement with the FDA regarding a Special
Protocol Assessment (SPA) on the design of SEAMLESS , our planned, pivotal Phase 3 trial in acute
myeloid leukemia (AML), said Spiro Rombotis, President and Chief Executive Officer of Cyclacel.
We have started to recruit clinical study sites and are pleased to learn that the key features of
the Phase 3 study design are acceptable to AML investigators. In addition we have bolstered our
balance sheet and continued to develop sapacitabine in patients with myelodysplastic syndromes
(MDS) and non-small cell lung cancer (NSCLC). We will be presenting Phase 2 MDS survival data at
the annual meeting of the American Society of Hematology in December 2010.
Cyclacel s product revenues were comprised of sales of Xclair Cream for radiation dermatitis and
Numoisyn Liquid and Numoisyn Lozenges for xerostomia. Product revenues for the quarter and nine
months ended September 30, 2010 were $0.2 million and $0.4 million, respectively, compared to $0.2
million and $0.7 million, respectively, for the same periods in 2009. The decrease in product
revenue for nine months ended September 30, 2010 was due to higher than anticipated product returns
of approximately $0.2 million, related to expiring product with a two-year shelf-life previously
sold into the marketplace. Since the first quarter of 2010, our manufacturer has increased shelf
life of certain of our products to three years.
Total operating expenses for the quarter ended September 30, 2010 increased to $4.2 million
compared to $3.7 million for the same period in 2009. For the nine months ended September 30,
2010, total operating expenses decreased to $13.4 million compared to $14.7 million for the same
Research and Development Expenses
Cyclacel s research and development expenses for the third quarter of 2010 increased to $1.5
million as compared to $1.4 million for the same period in 2009. For the nine months ended
September 30, 2010 research and development expenses were $5.0 million as compared to $7.2 million
for the same period in 2009. The $2.2 million decrease in research and development expenses was
primarily associated with the Company s lower cost base following headcount reductions in 2008 and
2009 and the concentration of resources on sapacitabine, Cyclacel s lead drug candidate.
Selling, General and Administrative Expenses
Total selling, general and administrative expenses for the third quarter of 2010 increased to $2.6
million as compared to $2.2 million for the third quarter of 2009. For the nine months ended
September 30, 2010 total selling, general and administrative expenses were $8.1 million versus $6.7
million for the same period in 2009. The increase in selling, general and administrative expenses
was primarily due to increased spending on professional and consultancy costs.
Cash and Cash Equivalents
As of September 30, 2010, Cyclacel s cash and cash equivalents were $18.5 million compared to $11.5
million as of December 31, 2009. The Company s cash and cash equivalents does not include $14.1
million in net proceeds from the private placement completed in October 2010.
Conference call and Webcast Information:
Cyclacel management will review third quarter 2010 financial and business highlights on a
conference call scheduled for today at 4:30 p.m. Eastern. Conference call and webcast details are
US/Canada call: (877) 493-9121/ international call: (973) 582-2750
US/Canada archive: (800) 642-1687 / international archive: (706) 645-9291
Code for live and archived conference call is 22901304.
Webcast: For the live and archived webcast, please visit the Corporate Presentations page on the
Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of
cell cycle control for the treatment of cancer and other serious diseases. Three product
candidates are in clinical development. Sapacitabine (CYC682), a cell cycle modulating nucleoside
analog, will be entering Phase 3 development for the treatment of Acute Myeloid Leukemia in the
elderly under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration,
and is in Phase 2 studies for myelodysplastic syndromes and lung cancer. Seliciclib (CYC202 or
R-roscovitine), a CDK (cyclin dependent kinase) inhibitor, is in Phase 2 studies for the treatment
of lung cancer and nasopharyngeal cancer and in a Phase 1 trial in combination with sapacitabine.
CYC116, an Aurora kinase and VEGFR2 inhibitor, is in a Phase 1 trial in patients with solid tumors.
Cyclacel s ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair Cream for
radiation dermatitis, Numoisyn Liquid and Numoisyn Lozenges for xerostomia. Cyclacel s strategy
is to build a diversified biopharmaceutical business focused in hematology and oncology based on a
portfolio of commercial products and a development pipeline of novel drug candidates. Please visit
www.cyclacel.com for additional information.
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties
that could cause actual results to be materially different from historical results or from any
future results expressed or implied by such forward-looking statements. Such forward-looking
statements include statements regarding, among other things, the efficacy, safety, and intended
utilization of Cyclacel s product candidates, the conduct and results of future clinical trials,
plans regarding regulatory filings, future research and clinical trials and plans regarding
partnering activities. Factors that may cause actual results to differ materially include the risk
that product candidates that appeared promising in early research and clinical trials do not
demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that Cyclacel
will not obtain approval to market its products, the risks associated with reliance on outside
financing to meet capital requirements, and the risks associated with reliance on collaborative
partners for further clinical trials, development and commercialization of product candidates. You
are urged to consider statements that include the words may, will, would, could, should,
believes, estimates, projects, potential, expects, plans, anticipates, intends,
continues, forecast, designed, goal, or the negative of those words or other comparable
words to be uncertain and forward-looking. For a further list and description of the risks and
uncertainties the Company faces, please refer to our most recent Annual Report on Form 10-K and
other periodic and current filings that have been filed with the Securities and Exchange Commission
and are available at www.sec.gov. Such forward-looking statements are current only as of
the date they are made, and we assume no obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise.
Contact for Cyclacel Pharmaceuticals, Inc.
Corey Sohmer, (908) 517-7330
CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s except share and per share amounts)