Full Press Release Details
CYCLACEL PHARMACEUTICALS REPORTS SECOND QUARTER 2011 FINANCIAL RESULTS
Conference Call Scheduled August 11, 2011 at 4:30 p.m. Eastern Time
Berkeley Heights, NJ, August 11, 2011 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ:
CYCCP; Cyclacel or the Company), announced today its financial results and business highlights for
the second quarter of 2011.
The Company s net loss applicable to common stockholders for the second quarter of 2011 was $3.7
million, or $0.08 per basic and diluted share, compared to a net loss applicable to common
stockholders of $6.5 million or $0.18 per basic and diluted share, for the second quarter of 2010.
For the six months ended June 30, 2011, the Company reported a net loss applicable to common
stockholders of $8.5 million, or $0.18 per basic and diluted share, compared to a net loss of $12.4
million, or $0.36 per basic and diluted share, for the six months ended June 30, 2010.
We are encouraged by the data presented at the 2011 ASCO meeting from a pilot study evaluating
sapacitabine dosed sequentially with decitabine, a treatment regimen that mirrors the lead-in arm
of our on-going Phase 3 SEAMLESS study, said Spiro Rombotis, President and Chief Executive Officer
of Cyclacel. We have recently completed patient enrollment in the lead-in stage of SEAMLESS which
reflects continued interest by investigators and patients in our program. Later this year the
SEAMLESS Drug Safety Monitoring Board, or DSMB, will conduct its first review of the lead-in data
which, if positive, would enable the randomization stage of SEAMLESS to begin. We are excited
about our progress toward realizing the potential of sapacitabine and the rest of our innovative
| Completed patient enrollment in the lead-in stage of the sapacitabine Phase 3 SEAMLESS study of elderly patients with AML who are not eligible for intensive chemotherapy. | |||
| Reported results at the 2011 ASCO meeting from a pilot study evaluating the same treatment regimen of sapacitabine dosed sequentially with decitabine, as one of the arms in SEAMLESS, the registration-directed, Phase 3 study of sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia. In the multicenter, Phase 1/2 clinical trial examining the safety and effectiveness of oral sapacitabine administered sequentially with decitabine, 30-day mortality from all causes was 4.5% and 60-day mortality from all causes was 9.5%. The overall response rate was 34.8%. | |||
| Completed an underwritten registered direct offering for an aggregate of 7,617,646 units, at an offering price of $1.36 per unit, for gross proceeds of $10.4 million. Each unit consists of (i) one share of common stock, and (ii) a five-year warrant to purchase 0.5 share of common stock at an exercise price of $1.36 per share, exercisable beginning six months after the date of issuance. | |||
| Amended the sapacitabine licensing agreement with Daiichi Sankyo, whereby Daiichi Sankyo irrevocably waived a termination right it possessed under a provision of the license agreement. The amendment further provides that the royalty on future net sales of sapacitabine be increased by a percentage between 1.25% and 1.50% depending on the level of net sales of sapacitabine realized. |
| 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922 USA T: 1 (908) 517 7330 F: 1 (866) 271 3466 | ||
| Dundee Technopole, James Lindsay Place, Dundee, DD1 5JJ, UK Tel 44 1382 206 062 Fax 44 1382 206 067 |
| Continued enrolment in the sapacitabine Phase 2 study in patients with Non-Small Cell Lung Cancer, or NSCLC, who failed at least one prior therapy. | |||
| Continued collection of patient specimens from the APPRAISE randomized, double-blinded, randomized discontinuation, Phase 2b study of seliciclib in patients with NSCLC who failed at least two prior therapies. |
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 six
months ended June 30, 2011 were $0.2 million and $0.4 million, respectively, compared to
approximately $19,000 and $0.3 million, respectively, for the same periods in 2010.
Total operating expenses for the quarter ended June 30, 2011 decreased to $4.0 million compared to
$4.5 million for the same period in 2010. For the six months ended June 30, 2011, total operating
expenses decreased to $9.0 million, which included a $1.6 million milestone payment, compared to
$9.2 million for the same period in 2010.
Research and Development Expenses
Research and development expenses for the second quarter of 2011 increased to $1.9 million as
compared to $1.3 million for the same period in 2010. For the six months ended June 30, 2011,
research and development expenses were $4.9 million as compared to $3.5 million for the same period
in 2010. The increase was due to a $1.6 million milestone in the first quarter payable to
Daiichi-Sankyo as part of our contractual obligation resulting from sapacitabine s entry into Phase
Selling, General and Administrative Expenses
Total selling, general and administrative expenses for the second quarter of 2011 decreased to $2.0
million as compared to $3.1 million for the second quarter of 2010. For the six months ended June
30, 2011 total selling, general and administrative expenses were $3.8 million as compared to $5.5
million for the same period in 2010. The decrease of $1.6 million in expenses was primarily
attributable to a net decrease in professional and consultancy costs and, to a lesser extent, a
decrease in salaries and also an elimination of costs related to a facility lease that expired in
Cash and Cash Equivalents
June 30, 2011, Cyclacel s cash and cash equivalents were $20.6 million compared to $29.5
million as of December 31, 2010. The Company s cash and cash equivalents do not include
approximately $9.3 million in net proceeds from the underwritten offering completed in July 2011.
Conference call and Webcast Information:
Cyclacel will conduct a conference call on August 11,, 2011 at 4:30 p.m., Eastern Time, to review
the second quarter and six months ended June 30, 2011 results. Conference call and webcast details
Conference call information:
US/Canada call: (877) 493-9121/ international call: (973) 582-2750.
US/Canada archive: (855) 859-2056 / international archive: (404) 537-3406.
Code for live and archived conference call is 89030684.
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 for 7
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. Sapacitabine (CYC682),
a cell cycle modulating nucleoside analog, is in Phase 3 development for the front-line treatment
of acute myeloid leukemia in the elderly and 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. 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, trials may have
difficulty enrolling, Cyclacel may not obtain approval to market its products, the risks associated
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, csohmer@cyclacel.com
Cyclacel are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn and Xclair are trademarks of
Sinclair Pharma plc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Period from | ||||||||||||||||||||
| August 13, | ||||||||||||||||||||
| 1996 | ||||||||||||||||||||
| (inception) | ||||||||||||||||||||
| For the three | For the six | To | ||||||||||||||||||
| months ended | months ended | December | ||||||||||||||||||
| June 30 | June 30 | 31, | ||||||||||||||||||
| 2010 | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||
| ($000s) | ||||||||||||||||||||
| Revenues: | ||||||||||||||||||||
| Collaboration and research and development revenue | 100 | 100 | 3,100 | |||||||||||||||||
| Product revenue | 19 | 168 | 273 | 360 | 2,682 | |||||||||||||||
| Grant revenue | 16 | 3,648 | ||||||||||||||||||
| 119 | 168 | 389 | 360 | 9,430 | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||
| Cost of goods sold | 92 | 72 | 234 | 178 | 1,570 | |||||||||||||||
| Research and development | 1,322 | 1,859 | 3,497 | 4,939 | 181,482 | |||||||||||||||
| General and administrative | 3,091 | 2,034 | 5,491 | 3,840 | 85,806 | |||||||||||||||
| Goodwill and intangibles impairment | 7,934 | |||||||||||||||||||
| Restructuring costs | 2,634 | |||||||||||||||||||
| Total operating expenses | 4,505 | 3,965 | 9,222 | 8,957 | 279,476 | |||||||||||||||
| Operating loss | (4,386 | ) | (3,797 | ) | (8,833 | ) | (8,597 | ) | (270,046 | ) | ||||||||||
| 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 | 273 | 125 | (516 | ) | 203 | 6,273 | ||||||||||||||
| Warrant re-pricing | (44 | ) | ||||||||||||||||||
| Foreign exchange gains/(losses) | (49 | ) | (19 | ) | (38 | ) | (85 | ) | (4,342 | ) | ||||||||||
| Interest income | 8 | 13 | 17 | 24 | 13,704 | |||||||||||||||
| Interest expense | (9 | ) | (33 | ) | (4,677 | ) | ||||||||||||||
| Total other income (expense), net | 223 | 119 | (570 | ) | 140 | 5,404 | ||||||||||||||
| Loss before taxes | (4,163 | ) | (3,678 | ) | (9,403 | ) | (8,457 | ) | (264,642 | ) | ||||||||||
| Income tax benefit | 230 | 126 | 363 | 317 | 18,196 | |||||||||||||||
| Net loss | (3,933 | ) | (3,552 | ) | (9,040 | ) | (8,140 | ) | (246,446 | ) | ||||||||||
| Dividends on preferred ordinary shares | (38,123 | ) | ||||||||||||||||||
| Deemed dividend on convertible exchangeable preferred shares | (2,496 | ) | (2,915 | ) | (3,515 | ) | ||||||||||||||
| Dividend on convertible exchangeable preferred shares | (114 | ) | (182 | ) | (403 | ) | (364 | ) | (3,293 | ) | ||||||||||
| Net loss applicable to common stockholders | (6,543 | ) | (3,734 | ) | (12,358 | ) | (8,504 | ) | (291,377 | ) | ||||||||||
| Net loss per share basic and diluted | $ | (0.18 | ) | $ | (0.08 | ) | $ | (0.36 | ) | $ | (0.18 | ) | ||||||||
| Weighted average common shares outstanding | 36,565,972 | 46,582,915 | 34,157,279 | 46,577,577 |
CYCLACEL PHARMACEUTICALS, INC.