Cyclacel Reports Third Quarter 2012 Financial Results

Cyclacel Reports Third Quarter 2012 Financial Results

- Enrollment in SEAMLESS Phase 3 study of sapacitabine proceeding as planned;
updated survival data from the pilot/lead-in stage of SEAMLESS to be presented
    at the upcoming annual meeting of the American Society of Hematology -

  - Conference Call Scheduled November 12, 2012 at 4:30 p.m. Eastern Time -

BERKELEY HEIGHTS, N.J., Nov. 12, 2012 (GLOBE NEWSWIRE) -- Cyclacel
Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company),
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
third quarter ended September 30, 2012.

The Company's net loss applicable to common stock shareholders, which includes
the discontinuation of the ALIGN business, for the third quarter of 2012 was
$2.1 million, or $0.25, per basic and diluted share, compared to a net loss
applicable to common stock shareholders, of $3.6 million, or $0.47 per basic
and diluted share, for the third quarter of 2011. For the nine months ended
September 30, 2012 the Company's net loss applicable to common stock
shareholders was $9.0 million, or $1.09 per basic and diluted share, compared
to a net loss applicable to common stock shareholders of $12.1 million, or
$1.73 per basic and diluted share. As of September 30, 2012, cash and cash
equivalents totaled $17.8 million.

"Cyclacel continues to execute on its plan for the SEAMLESS pivotal, Phase 3
study of sapacitabine as front-line treatment in acute myeloid leukemia (AML)
in elderly patients who are not candidates for or have refused induction
chemotherapy," said Spiro Rombotis, President and Chief Executive Officer of
Cyclacel. "After opening 36 clinical sites in the US, we have achieved a few
weeks ago the enrollment milestone of surpassing 100 patients. With the
randomized stage of SEAMLESS currently reaching its first anniversary, we are
encouraged to see that the study has strong support by investigators. In
addition, we look forward to reporting at the upcoming 2012 Annual Meeting of
the American Society of Hematology (ASH) updated survival data from the entire
population enrolled in the pilot/lead-in stage of SEAMLESS. In parallel, we
are preparing regulatory submissions with the goal of defining a registration
pathway for sapacitabine in patients with myelodysplastic syndromes (MDS) who
failed treatment with front-line hypomethylating agents. Sapacitabine is part
of Cyclacel's deep pipeline of novel medicines designed to target and stop
uncontrolled cell division."

Business Highlights

  *Published results from a Phase 2 randomized trial of single-agent
    sapacitabine in elderly patients aged 70 years or older with newly
    diagnosed AML or AML in first relapse in The Lancet Oncology.
  *Presented updated data at two separate sessions at The Eighth Annual
    Hematologic Malignancies 2012 Conference from an ongoing, multicenter,
    Phase 2 randomized trial of sapacitabine in older patients with
    intermediate-2 or high-risk MDS after treatment failure of front-line
    hypomethylating agents, such as azacitidine (Vidaza®) and/or decitabine
    (Dacogen®). Median overall survival to date for all 63 patients in the
    Phase 2 study is approximately 8 months. For 41 out of 63 patients with
    10% to 19% blasts in their bone marrow median overall survival is
    approximately 9 months. Twenty-two percent of patients are still alive and
    longer follow-up is needed to assess 1-year survival and overall survival
    of each arm.
  *Received a grant of approximately $1.9 million from the UK Government's
    Biomedical Catalyst to complete investigational new drug (IND)-directed
    preclinical development of CYC065, a novel, orally available, second
    generation, cyclin-dependent kinase (CDK) inhibitor.
  *Highlighted in multiple poster presentations the personalized medicine
    potential of Cyclacel's innovative and diverse oncology pipeline at the
    8th National Cancer Research Institute (NCRI) Cancer Conference, including
    translational findings demonstrating the combination potential of
    sapacitabine in patients with BRCA1/2 or homologous recombination repair
    (HRR) pathway defects and the Company's Polo-Like Kinase 1 (Plk1)
    inhibitors.
  *Entered into an agreement with Sinclair Pharmaceuticals Limited
    ("Sinclair") to terminate, effective September 30, 2012, the distribution
    agreements relating to the promotion and sale of Xclair®, Numoisyn®
    Lozenges and Numoisyn® Liquid in exchange for a minimum of approximately
    $1 million in royalty revenues over a period ending in September 2015.
  *Implemented a 1-for-7 reverse stock split of shares of common stock in
    order to satisfy the $1.00 minimum bid requirement for continued listing
    on the NASDAQ Global Market.

Third Quarter and Year to Date 2012 Financial Results

Research and Development Expenses

Research and development expenses in the third quarter of 2012 were $1.5
million compared to $2.1 million for the same period in 2011. Research and
development expenses for the nine months ended September 30, 2012 and 2011
were $4.6 million and $7.0 million, respectively. The decrease in research and
development expenses was primarily due to a contractual payment of $1.6
million to Daiichi Sankyo during the first quarter of 2011 related to a
milestone payment triggered by the opening of enrollment in the SEAMLESS Phase
3 trial.

Selling, General and Administrative Expenses (SG&A)

Total SG&A expenses for the third quarter of 2012 were $2.0 million, compared
to $1.8 million for the same period in 2011. Total SG&A expenses for the nine
months ended September 30, 2012 and 2011 were $5.9 million and $5.1 million,
respectively. The increased expenses during 2012 were primarily related to
professional and consultancy costs.

Discontinued Operations

In August 2012, we entered into an agreement with Sinclair to terminate,
effective September 30, 2012, the distribution agreements relating to the
promotion and sale of Xclair®, Numoisyn® Lozenges and Numoisyn® Liquid. The
agreement includes a minimum royalty arrangement based on future net revenues,
under which Sinclair will pay Cyclacel a minimum of approximately $1.0 million
in quarterly installments over the next three years ending on September 30,
2015.

Cash and Cash Equivalents

As of September 30, 2012, Cyclacel's cash and cash equivalents were $17.8
million compared to $24.4 million as of December 31, 2011. The Company expects
that its cash resources are sufficient to meet anticipated working capital
needs and fund ongoing sapacitabine clinical trials for at least the next
twelve months.

Cyclacel's Goals for the remainder of 2012 and 2013

  *Continue enrollment in the SEAMLESS pivotal Phase 3 study of sapacitabine
    in AML;
  *Report updated survival data of the pilot /lead-in stage of SEAMLESS at
    the 2012 Annual Meeting of the American Society of Hematology;
  *Report updated Phase 2 sapacitabine data in 2^nd line MDS following
    treatment failure after hypomethylating agents;
  *Report updated Phase 2 sapacitabine data in AML preceded by MDS following
    previous treatment with hypomethylating agents for the preceding MDS;
  *Report updated Phase 1 sapacitabine and seliciclib combination data in
    patients with solid tumors;
  *Report updated Phase 2 sapacitabine data in non-small cell lung cancer
    (NSCLC); and
  *Report updates from investigator-sponsored trials (IST) including the
    "Pick a Winner/LI-1" IST in AML & high-risk MDS and other ISTs in leukemia
    and lymphoma as they become available.

Conference call and Webcast Information:

Cyclacel will conduct a conference call on November 12, 2012 at 4:30 p.m.
Eastern Time to review the third quarter results. Conference call and webcast
details are as follows:

Conference call information:
US/Canada call: (877) 493-9121/ international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406
Code for live and archived conference call is 69718892

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 biopharmaceutical company developing oral therapies that target
the various phases of cell cycle control for the treatment of cancer and other
serious diseases. The Company's most advanced oral product candidate,
sapacitabine, is the subject of SEAMLESS, a Phase 3 trial being conducted
under an SPA with the FDA as front-line treatment of acute myeloid leukemia
(AML) in the elderly and Phase 2 studies for AML, myelodysplastic syndromes
(MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast,
lung, ovarian and pancreatic cancer. Cyclacel's pipeline includes seliciclib,
a CDK inhibitor, in Phase 2 for lung and nasopharyngeal cancer and in Phase 1
in combination with sapacitabine; and CYC065, a second generation CDK
inhibitor, in IND-directed development. Cyclacel's strategy is to build a
diversified biopharmaceutical business focused in hematology and oncology
based on 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 product candidates, 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 other filings we file 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.

© Copyright 2012 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
Numoisyn® and Xclair® are trademarks of Sinclair Pharma plc. Vidaza® is a
registered trademark of Celgene Corporation. Dacogen® is a registered
trademark used by Eisai Inc. under license from Astex Pharmaceuticals, Inc.

                                      

CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
(Unaudited)
                                                      
                                 Three Months Ended    Nine Months Ended
                                  September 30,         September 30,
                                 2011       2012       2011        2012
Revenues:                                                        
Collaboration and research and    $—       $—       $—        $—
development revenue
Grant revenue                     —        38        —          64
Total revenues                    —         38        —           64
Operating expenses:                                              
Research and development          2,066     1,532     7,005       4,596
Selling, general and              1,814     2,028     5,136       5,917
administrative
Goodwill and intangible           —       —        —          —
impairment
Restructuring costs               —       —        —          —
Total operating expenses          3,880     3,560     12,141      10,513
Operating loss                    (3,880)   (3,522)   (12,141)    (10,449)
Other income (expense):                                          
Costs associated with aborted     —         —         —           —
2004 IPO
Payment under guarantee           —         —         —           —
Change in valuation of Economic   —         (63)      —           27
Rights
Change in valuation of other
liabilities measured at fair      440    1         643         51
value
Foreign exchange (losses)/gains   28       6         (59)        237
Interest income                   9        5         33         17
Interest expense                  —        —        —          —
Other income                      —        1        —          77
Total other income (expense).     477       (50)     617         409
Loss from continuing operations   (3,403)   (3,572)   (11,524)    (10,040)
before taxes
Income tax benefit                126      419       443        714
Net loss from continuing          (3,277)   (3,153)   (11,081)    (9,326)
operations
Discontinued operations:                                         
Income (loss) from discontinued   (168)     1,263     (504)       904
operations, net of tax
Net loss                          (3,445)   (1,890)   (11,585)    (8,422)
Dividends on preferred ordinary   —         —         —           —
shares
Deemed dividend on convertible    —       —        —          —
exchangeable preferred shares
Dividend on convertible           (182)  (182)   (546)      (546)
exchangeable preferred shares
Net loss applicable to common     $(3,627) $(2,072) $ (12,131) $(8,968)
shareholders
Net loss per share, continuing    $(0.43)  $(0.37)  $(1.58)   $(1.13)
operations– Basic and diluted
Net income (loss) per share,
discontinued operations– Basic   $(0.02)  $0.15    $(0.07)   $0.11
and diluted
Net loss per share – Basic and    $(0.47)  $(0.25)  $(1.73)   $(1.09)
diluted
Weighted average common shares    7,673,096 8,429,269 6,997,391  8,227,721
outstanding.

                                      


CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s, except share amounts)
                                                               
                                                   December 31, September 30,
                                                    2011         2012
                                                               (Unaudited)
ASSETS                                                          
Current assets:                                                 
Cash and cash equivalents                           $24,449    $17,837
Prepaid expenses and other current assets           1,069       1,235
Current assets of discontinued operations           313         881
Total current assets                                25,831      19,953
Property, plant and equipment (net)                 167         140
Long-term assets of discontinued operations         —           433
Total assets                                        $25,998    $20,526
                                                               
LIABILITIES AND STOCKHOLDERS' EQUITY                            
Current liabilities:                                            
Accounts payable                                    $1,717     $1,642
Accrued liabilities and other current liabilities   4,183       4,127
Economic rights                                     —           1,070
Other liabilities measured at fair value            71         20
Current liabilities of discontinued operations      527         438
Total current liabilities                           6,498       7,297
Total liabilities                                   6,498       7,297
Stockholders' equity:                                           
Preferred stock, $0.001 par value; 5,000,000 shares
authorized at December 31, 2011 and September 30,
2012; 1,213,142 shares issued and outstanding at
December 31, 2011 and September 30, 2012. Aggregate 1           1
preference in liquidation of $13,708,505 and
$14,254,419 at December 31, 2011 and September 30,
2012, respectively
Common stock, $0.001 par value; 100,000,000 shares
authorized at December 31, 2011 and September 30,
2012; 7,745,779 and 8,434,292 shares issued and     8           8
outstanding at December 31, 2011 and September 30,
2012, respectively
Additional paid-in capital                          276,498     278,655
Accumulated other comprehensive loss                57          51
Deficit accumulated during the development stage    (257,064)   (265,486)
Total stockholders' equity                          19,500      13,229
Total liabilities and stockholders' equity          $25,998    $20,526

CONTACT: Cyclacel Pharmaceuticals, Inc.
         Investors/Media:
         Corey Sohmer, (908) 517-7330, csohmer@cyclacel.com