Full Press Release Details
P R E S S R E L E A S E
CYCLACEL PHARMACEUTICALS REPORTS FINANCIAL RESULTS FOR FIRST QUARTER 2010
Conference Call Scheduled May 13, 2010 at 4:30 p.m. Eastern Time
BERKELEY HEIGHTS, NJ May 13, 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
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
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.
Conference call and Webcast Information:
Cyclacel management will review first 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 73236113
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 disorders. Three product
candidates are in clinical development: Sapacitabine (CYC682), a cell cycle modulating nucleoside
analog, is in Phase 2 studies for the treatment of acute myeloid leukemia in the elderly,
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 are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn and Xclair are trademarks
of Sinclair Pharma plc.
CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
| Period from | ||||||||||||
| August 13, 1996 | ||||||||||||
| Three Months Ended | (inception) to | |||||||||||
| March 31, | March 31, | |||||||||||
| 2009 | 2010 | 2010 | ||||||||||
| Revenues: | ||||||||||||
| Collaboration and research and development revenue | 3,000 | |||||||||||
| Product revenue | 216 | 254 | 2,002 | |||||||||
| Grant revenue | 12 | 17 | 3,652 | |||||||||
| 228 | 271 | 8,654 | ||||||||||
| Operating expenses : | ||||||||||||
| Cost of goods sold | 116 | 142 | 1,116 | |||||||||
| Research and development | 3,097 | 2,178 | 172,357 | |||||||||
| Selling, general and administrative | 2,230 | 2,402 | 74,248 | |||||||||
| Goodwill and intangible impairment | 7,934 | |||||||||||
| Restructuring costs | 2,634 | |||||||||||
| Total operating expenses | 5,443 | 4,722 | 258,289 | |||||||||
| Operating loss | (5,215 | ) | (4,451 | ) | (249,635 | ) | ||||||
| Other income (expense): | ||||||||||||
| Costs associated with aborted 2004 IPO | (3,550 | ) | ||||||||||
| Payment under guarantee | (1,652 | ) | ||||||||||
| Change in valuation of derivative | (308 | ) | ||||||||||
| Change in valuation of warrants | (8 | ) | (789 | ) | 5,575 | |||||||
| Foreign exchange losses | (137 | ) | 11 | (4,176 | ) | |||||||
| Interest income | 46 | 9 | 13,652 | |||||||||
| Interest expense | (107 | ) | (24 | ) | (4,657 | ) | ||||||
| Total other income (expense) | (206 | ) | (793 | ) | 4,884 | |||||||
| Loss before taxes | (5,421 | ) | (5,244 | ) | (244,751 | ) | ||||||
| Income tax benefit | 358 | 133 | 17,355 | |||||||||
| Net loss | (5,063 | ) | (5,111 | ) | (227,396 | ) | ||||||
| Dividends on preferred ordinary shares | (38,123 | ) | ||||||||||
| Deemed dividend on convertible exchangeable preferred shares | (419 | ) | (419 | ) | ||||||||
| Dividends on convertible exchangeable preferred shares | (307 | ) | (289 | ) | (2,846 | ) | ||||||
| Net loss applicable to common shareholders | (5,370 | ) | (5,819 | ) | (268,784 | ) | ||||||
| Net loss per share Basic and diluted | $ | (0.26 | ) | $ | (0.18 | ) | ||||||
| Weighted average common shares outstanding | 20,433,129 | 31,721,822 |