BERKELEY HEIGHTS, N.J., Nov. 3, 2009 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company") announced today financial and operating results for the third quarter of 2009. The Company's net loss for the quarter was $3.1 million or $0.13 per share. This compared to a net loss of $17.6 million or $0.86 loss per share for the same period in 2008. As of September 30, 2009, the Company had $14.4 million in cash and cash equivalents.
"Our recent achievement of 30% one-year survival in two of the three randomized schedules of the Phase 2 study of sapacitabine as a treatment for elderly patients aged 70 and older with acute myeloid leukemia (AML) provides a strong rationale supporting the continued development of this novel agent," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are working with the FDA to design a registration study for sapacitabine in hematological malignancies. We continue to concentrate our efforts on advancing sapacitabine into Phase 3 development for AML and/or myelodysplastic syndromes (MDS) while preserving cash for the next twelve months. We are also looking forward to reporting in 2010 data from our ongoing Phase 2 studies of sapacitabine and seliciclib in lung cancer."
Recent Highlights:
-- Reported 30% one-year survival from the Phase 2 sapacitabine
trial in elderly patients with AML aged 70 and older in two
out of three randomized schedules;
-- Type A meeting granted by the FDA in the 4th quarter of 2009
to discuss the design of Phase 3 registration studies in AML
and/or MDS;
-- Phase 3 study designs to be included in an upcoming submission
requesting a Special Protocol Assessment or SPA;
-- Raised $3.4 million in gross proceeds in a registered direct
offering in July.
Key Financials:
Total revenues for the third quarter of 2009 were $0.2 million representing a decrease of 14% compared to $0.3 million for the same period in 2008. These revenues were mainly attributable to sales of the Xclair(r) and Numoisyn(r) products.
Total research and development (R&D) expenses in the third quarter of 2009 were $1.4 million, a 65% decrease as compared to $4.0 million in the third quarter of 2008. $1.6 million of the overall decrease was associated with the discontinuation of the Company's preclinical programs from the cost-containment measures implemented in September 2008 and June 2009. The Company recognized cost reductions of approximately $1.0 million in the third quarter 2009 as compared to the same period in 2008 due to the completion of patient enrollment in the APPRAISE trial in the third quarter of 2008.
Total selling, general and administrative expenses (SG&A) for the third quarter of 2009 were $2.2 million, a 32% decrease as compared to $3.2 million in the third quarter of 2008. The reduction in operating expenses in the third quarter of 2009 compared to the same period in 2008 is primarily attributable to the cost-containment measures implemented in September 2008 and June 2009 and the concentration of the Company's resources on the clinical development of sapacitabine.
Other operating expenses in the third quarter of 2008 also included a non-cash charge of $6.8 million for goodwill and intangibles impairment in respect of the acquisitions of Xcyte Therapies, Inc. and ALIGN following Cyclacel's annual test for impairment and restructuring costs.
Other income (expense) showed income of $0.2 million in the third quarter of 2009 as compared to expense of $4.1 million in the third quarter of 2008. The decrease in expense was primarily due to an unrealized foreign exchange loss of $4.8 million in the third quarter of 2008 compared to a $0.1 million foreign exchange gain in the same period in 2009 arising from intercompany loans with our wholly-owned subsidiaries due to the translation effects of the U.S. dollar against the British pound together with a change in the valuation of warrants and a reduction in interest income earned.
The net loss in the third quarter of 2009 was $3.1 million or $0.13 per share as compared to $17.6 million in the third quarter of 2008 or $0.86 per share.
Cyclacel also reported results of its operations for the nine months ended September 30, 2009. Total revenues for the nine months ended September 30, 2009 were $0.7 million representing an increase of 16% compared to $0.6 million for the same period in 2008. These revenues were mainly attributable to sales of the Xclair(R) and Numoisyn(R) products.
For the nine months ended September 30, 2009, R&D expenses were $7.2 million, a 54% decrease as compared to $15.7 million in the comparable period in 2008.
For the nine months ended September 30, 2009, SG&A expenses were $6.7 million, a 41% decrease as compared to $11.3 million in the comparable period in 2008.
The reduction in operating expenses in 2009 compared to 2008 is primarily attributable to the cost-containment measures implemented in September 2008 and June 2009 and the concentration of the Company's resources on the clinical development of sapacitabine.
Other operating expenses for the nine months ended September 30 2008 also included a non-cash charge of $6.8 million for goodwill and intangibles impairment in respect of the acquisitions of Xcyte and ALIGN and restructuring costs. For the nine months ended September 30, 2009, the Company recorded restructuring costs of $0.4 million.
Other income (expense) for the nine months ended September 30, 2009 showed an expense of $2.0 million as compared to $0.4 million for the same period in 2008. The 2009 loss included a non-operating expense of $1.7 million related to payments due under an agreement with Scottish Enterprise as a consequence of the headcount reductions implemented by the Company. During 2008, the Company recorded a charge of $3.3 million associated with the warrant derivative as compared to income of $0.2 million in 2009 as a result of the Company's common stock price at each quarter end. The decrease in expense was primarily due to unrealized foreign exchange loss of $4.6 million in the nine months ended September 30, 2008 compared to $0.1 million foreign exchange loss in the same period in 2009 arising mostly from intercompany loans with our wholly-owned subsidiaries due to the translation effects of the U.S. dollar against the British pound.
For the nine months ended September 30, 2009, the Company reported a net loss of $15.2 million or $0.71 per share, compared to a net loss for the same period in 2008 of $32.4 million or $1.59 per share.
Conference call and Webcast Information:
Cyclacel management will conduct a conference call on November 3, 2009 at 4:30 p.m. Eastern Time to review the quarterly results. Conference call and webcast details are as follows:
Conference call information:
U.S./Canada call: (877) 493-9121/ international call: (973) 582-2750 U.S./Canada archive: (800) 642-1687 / international archive: (706) 645-9291
Code for live and archived conference call is 37927625
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 days.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a diversified biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. Sapacitabine, 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 and in Phase 1 in combination with seliciclib. Seliciclib, a CDK (cyclin dependent kinase) inhibitor, is in Phase 2 for the treatment of lung and nasopharyngeal cancer. CYC116, an Aurora kinase and VEGFR2 inhibitor, is in Phase 1 in patients with solid tumors. Cyclacel's ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair(R) Cream for radiation dermatitis, Numoisyn(R) Liquid and Numoisyn(R) 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.
Risk factors
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. These factors and others are more fully discussed under "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2008, as supplemented by the interim quarterly reports, filed with the SEC.
The Cyclacel logo and Cyclacel(R) are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn(R) and Xclair(R) are trademarks of Sinclair Pharma plc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Period
from
August 13,
1996
For the three For the nine (inception)
months ended months ended to
September 30, September 30, Sept. 30,
--------------------- --------------------- ----------
2008 2009 2008 2009 2009
---------- ---------- ---------- ---------- ----------
($000s)
Revenues:
Collaboration
and research
and
development
revenue -- -- -- -- 3,000
Product
revenue 257 223 590 688 1,526
Grant
revenue 12 7 36 36 3,671
---------- ---------- ---------- ---------- ----------
269 230 626 724 8,197
---------- ---------- ---------- ---------- ----------
Operating
expenses:
Cost of
goods sold 120 163 315 472 901
Research and
development 4,030 1,394 15,718 7,174 167,587
General and
administra-
tive 3,218 2,188 11,337 6,703 70,011
Goodwill and
intangibles
impairment 6,344 -- 6,344 -- 7,934
Restructuring
costs 489 -- 489 366 2,634
---------- ---------- ---------- ---------- ----------
Total
operating
expenses 14,201 3,745 34,203 14,715 249,067
---------- ---------- ---------- ---------- ----------
Operating
loss (13,932) (3,515) (33,577) (13,991) (240,870)
Other income
(expense):
Costs
associated
with aborted
2004 IPO -- -- -- -- (3,550)
Payment
under
guarantee -- -- -- (1,652) (1,652)
Change in
valuation
of
derivative -- -- -- -- (308)
Change in
valuation
of warrants 432 101 3,321 (195) 6,512
Foreign
exchange
gains/
(losses) (4,776) 119 (4,638) (129) (4,172)
Interest
income 287 7 1,184 94 13,635
Interest
expense (69) (41) (244) (156) (4,613)
---------- ---------- ---------- ---------- ----------
Total other
income
(expense) (4,126) 186 (377) (2,038) 5,852
---------- ---------- ---------- ---------- ----------
Loss before
taxes (18,058) (3,329) (33,954) (16,029) (235,018)
Income tax
benefit 411 205 1,511 796 17,070
---------- ---------- ---------- ---------- ----------
Net loss (17,647) (3,124) (32,443) (15,233) (217,948)
Dividends on
Preferred
Ordinary
shares -- -- -- -- (38,123)
---------- ---------- ---------- ---------- ----------
Net loss
applicable
to common
shareholders (17,647) (3,124) (32,443) (15,233) (256,071)
---------- ---------- ---------- ---------- ----------
Net loss
per share -
basic and
diluted $ (0.86)$ (0.13)$ (1.59)$ (0.71)
---------- ---------- ---------- ----------
Weighted
average
shares 20,433,129 23,172,259 20,433,129 21,356,206
========== ========== ========== ==========
CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
As of As of
------------ ------------
December 31 September 30
------------ ------------
2008 2009
ASSETS
Current assets:
Cash and cash equivalents 24,220 14,433
Short-term investments 1,502 --
Inventory 508 140
Prepaid expenses and other current
assets 2,784 1,652
------------ ------------
Total current assets 29,014 16,225
Property, plant and equipment (net) 1,748 1,121
Deposits and other assets 195 196
------------ ------------
Total assets 30,957 17,542
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable 754 1,463
Accrued liabilities 5,186 5,228
Other current liabilities 1,615 1,336
Warrants liability 43 238
Current portion of other accrued
restructuring charges 1,029 1,063
------------ ------------
Total current liabilities 8,627 9,328
Other accrued restructuring charges,
net of current 1,062 267
Other long term payables 626 --
------------ ------------
Total liabilities 10,315 9,595
------------ ------------
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.001 par value;
5,000,000 shares authorized at
December 31, 2008 and September
30, 2009, respectively; 2,046,813
shares issued and outstanding at
December 31, 2008 and September
30, 2009, respectively
Aggregate preference in liquidation
of $20,673,000 at December 31,
2008 and September 30, 2009 2 2
Common stock, $0.001 par value;
100,000,000 shares authorized at
December 31, 2008 and September
30, 2009; 20,433,129, and
24,433,129 shares issued and
outstanding at December 31, 2008
and September 30, 2009,
respectively 20 24
Additional paid in capital 223,377 225,864
Accumulated other comprehensive loss (42) 5
Deficit accumulated during the
development stage (202,715) (217,948)
------------ ------------
Total stockholders' equity 20,642 7,947
------------ ------------
Total liabilities and
stockholders' equity 30,957 17,542
============ ============