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Cyclacel Reports Third Quarter 2013 Financial Results



Cyclacel Reports Third Quarter 2013 Financial Results

Conference Call Scheduled on November 12, 2013 at 4:30 p.m. Eastern Time

BERKELEY HEIGHTS, N.J., Nov. 12, 2013 (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, 2013. The net loss for the third quarter of
2013 was $5.0 million versus a net loss for the third quarter of 2012 of $1.9
million. As of September 30, 2013, cash and cash equivalents totaled $34.5
million. The Company's net loss applicable to common shareholders for the
third quarter of 2013 was $5.7 million, which includes $2.6 million of expense
related to clinical trial drug supply, or $0.32 per basic and diluted share,
compared to a net loss applicable to common shareholders of $2.1 million or
$0.25 per basic and diluted share for the third quarter of 2012.

"We have been executing on our sapacitabine development plan by progressing
enrollment in SEAMLESS, our pivotal, Phase 3 study in acute myeloid leukemia
(AML) and our Phase 2 study in myelodysplastic syndromes (MDS). With
approximately $35 million on our balance sheet, we have the resources to take
us beyond the completion of SEAMLESS," stated Spiro Rombotis, Cyclacel's
President and Chief Executive Officer. "SEAMLESS is close to the 50%
enrollment mark from only US sites. In parallel we are expanding the study
into Europe and expect to at least double the number of enrolling sites.
Primary clinical outcomes from the MDS study will be reported at ASH 2013 with
the aim of selecting a dosing schedule for Phase 3. We look forward to
reporting the outcome of an upcoming DSMB review of SEAMLESS, MDS survival
data at ASH 2013 and updates from other ongoing studies," added Mr. Rombotis.

Business Highlights

  * Announced that researchers will present new data from an ongoing,
    multicenter, Phase 2 randomized trial of oral sapacitabine capsules, the
    Company's lead product candidate, in older patients with intermediate-2 or
    high-risk myelodysplastic syndromes (MDS) after treatment failure of
    front-line hypomethylating agents, such as azacitidine and/or decitabine,
    at the 55th Annual Meeting of the American Society of Hematology (ASH) in
    December 2013. The data will include the primary endpoint of one year
    survival which will enable selection of a dosing schedule for Phase 3.
  * Reported that the US Patent and Trademark Office (USPTO) issued two
    patents extending the exclusivity of sapacitabine. The first patent
    claims, among others, methods of treating cancer comprising sapacitabine
    together with DNA methyltransferase inhibitors, including azacitidine and
    decitabine. The second patent claims methods of use for sapacitabine for
    the treatment of acute myeloid leukemia (AML) and myelodysplastic
    syndromes (MDS), including the dosing regimen used in SEAMLESS, the
    Company's pivotal Phase 3 study in front-line elderly AML.
  * Announced updated data showing that sapacitabine has activity against a
    majority of ovarian cancer samples taken from patients, including
    resistant tumors. The data were reported at a poster presentation during
    the American Association of Cancer Research (AACR) conference "Advances in
    Ovarian Cancer from concept to clinic" held in September 2013.
  * Announced that seliciclib, the Company's oral CDK inhibitor, is to be
    evaluated in an investigator-initiated clinical study to treat rheumatoid
    arthritis (RA) supported by an approximately $1.5 million grant from the
    UK's Medical Research Council. Enabled by the clinical development
    experience in solid tumors, investigators believe that seliciclib's
    mechanism of action and oral administration route may be of benefit in
    treating patients with RA.
  * Issued 805,787 additional shares of common stock allowed under a Common
    Stock Purchase Agreement with Aspire Capital in consideration for
    aggregate proceeds of $3.2 million.
  * Converted 85,409 shares of preferred stock into 170,818 shares of common
    stock. As a result, 335,273 shares of preferred stock remain outstanding
    at September 30, 2013.

Third Quarter 2013 Financial Results

Research and Development Expenses

Research and development expenses in the third quarter of 2013 were $4.6
million compared to $1.5 million for the same period in 2012, with the
increase of $3.1 million mainly attributable to clinical trial and
manufacturing costs, including an expense of $2.6 million for clinical trial
drug supply for the Company's pivotal, Phase 3 SEAMLESS trial.

General and Administrative Expenses

Total general and administrative expenses for the third quarter of 2013 were
$1.5 million, compared to $2.0 million for the same period in 2012 with the
decrease of $0.5 million primarily related to professional and consultancy
costs, including legal fees.

Cash and Cash Equivalents

As of September 30, 2013, Cyclacel's cash and cash equivalents were $34.5
million compared to $16.4 million as of December 31, 2012. The increase in
cash and cash equivalents was primarily due to net proceeds of $19.0 million
from an underwritten public offering, proceeds of $6.6 million from the sale
of common stock under a Common Stock Purchase Agreement, and $5.0 million, net
of certain expenses, from the sale of four Cyclacel patents, partially offset
by net spending on operating activities of $12.8 million.

Cyclacel's Key Goals for the next 12 Months

  o Continue US enrollment and expand into Europe the SEAMLESS Phase 3 study
    of sapacitabine in AML;
  o Report outcomes from upcoming DSMB periodic safety reviews of SEAMLESS
    every 100 patients and futility when 212 pooled events have been observed;
  o Report at ASH 2013 the primary endpoint of the Phase 2 sapacitabine study
    in MDS after treatment failure of hypomethylating agents;
  o Announce registration-directed, clinical development plan for sapacitabine
    in MDS after treatment failure of hypomethylating agents;
  o Report updated data from the Phase 1 study of sapacitabine and seliciclib
    in patients with advanced solid tumors, including BRCA carriers; and
  o Advance selected pipeline programs.

Conference call and Webcast Information:

Cyclacel will conduct a conference call on November 12, 2013 at 4:30 p.m.
Eastern Time to review the third quarter results. Conference call and webcast
details are as follows:

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 96409070

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. Sapacitabine, Cyclacel's most advanced product candidate, is
the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the
FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly,
and other studies for myelodysplastic syndromes (MDS), chronic lymphocytic
leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic
cancer and in particular those carrying gBRCA mutations. 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 the Company's most recent
Annual Report on Form 10-K and other periodic and other filings Cyclacel files
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 Cyclacel assumes no obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise.

© Copyright 2013 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.

                                                                  
CYCLACEL PHARMACEUTICALS, INC.
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
 (Unaudited
                                                                  
                                                                 Period from
                                                                 August 13,
                                                                 1996
                       Three Months Ended   Nine Months Ended    (inception)
                                                                 to
                       September 30,        September 30,        September 30,
                       2012      2013       2012      2013       2013
Revenues:                                                         
Collaboration and
research and           $ --      $ --       $ --      $ --       $3,100
development revenue 
Grant revenue          38        309        64        785        4,502
Total revenues         38        309        64        785        7,602
Operating expenses:                                               
Research and           1,532     4,575      4,596     8,786      201,177
development 
 General and           2,028     1,529      5,917     5,999      95,410
administrative 
 Goodwill and           --        --         --        --        2,747
intangibles impairment
Other restructuring     --        --         --        --        2,634
costs 
Total operating        3,560     6,104      10,513    14,785     301,968
expenses
Operating loss         (3,522)   (5,795)    (10,449)  (14,000)   (294,366)
Other income                                                      
(expense):
Costs associated with  --        --         --        --         (3,550)
aborted 2004 IPO 
Payment under          --        --         --        --         (1,652)
guarantee 
Non-cash consideration
associated with stock  --        --         --        --         (423)
purchase agreement 
Change in valuation of (63)       --        27        570        547
Economic Rights 
Change in valuation
of liabilities         1          --        51         --        6,378
measured at fair value
Foreign exchange gain  6         25         237       44         (3,961)
(loss) 
Interest income        5         8          17        12         13,759
Interest expense        --        --         --        --        (4,567)
Other income           1         16         77        5,520      5,597
(expense), net 
Total other (expense)  (50)      49         409       6,146      12,128
income. 
Loss from continuing
operations before      (3,572)   (5,746)    (10,040)  (7,854)    (282,238)
taxes
Income tax benefit     419       730        714       1,218      21,013
Net loss from          (3,153)   (5,016)    (9,326)   (6,636)    (261,225)
continuing operations
Discontinued                                                      
operations:
(Loss) income from
discontinued           1,263     20         904       70         (11,739)
operations 
Income tax on
discontinued            --       (8)         --       (28)       (365)
operations 
Net income (loss) from
discontinued           1,263     12         904       42         (12,104)
operations 
Net loss               (1,890)   (5,004)    (8,422)   (6,594)    (273,329)
Dividend on preferred  --        --         --        --         (38,123)
ordinary shares 
Deemed dividend on
convertible            --        (661)      --        (9,027)    (12,542)
exchangeable preferred
shares 
Dividend on
convertible            (182)     (63)       (546)     (248)      (4,633)
exchangeable preferred
shares 
Net loss applicable to $(2,072)  $(5,728)   $(8,968)  $(15,869)  $(328,627)
common shareholders
                                                                  
Net loss per share,
continuing operations  $(0.40)   $(0.32)    $(1.20)   $(1.15)     
– Basic and diluted 
Net income per share,
discontinued           $0.15     $0.00      $0.11     $0.00       
operations – Basic and
diluted 
Net loss applicable to
common shareholders –  $(0.25)   $(0.32)    $(1.09)   $(1.15)     
Basic and diluted 
                                                                  
Weighted average
common shares          8,429,269 17,788,568 8,227,721 13,850,792  
outstanding 
                                                                  

                                                                 
CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s)
(Unaudited)
                                                                 
                                                   As of        As of 
                                                   December 31, September 30,
                                                   2012         2013
ASSETS                                                           
Current assets:                                                  
Cash and cash equivalents                          $16,412      $34,487
Prepaid expenses and other current assets          1,599        2,440
Current assets of discontinued operations          861          792
Total current assets                               18,872       37,719
Property, plant and equipment (net)                129          174
Long-term assets of discontinued operations        353          96
Total assets                                       $19,354      $37,989
                                                                 
LIABILITIES AND STOCKHOLDERS' EQUITY                             
Current liabilities:                                             
Accounts payable                                   $2,259       $2,352
Accrued liabilities and other current liabilities  5,601        6,284
Economic Rights measured at fair value             1,120        --
Other liabilities measured at fair value           20           20
Current liabilities of discontinued operations     335          322
Total current liabilities                          9,335        8,978
Total liabilities                                  9,335        8,978
Stockholders' equity:                                            
Preferred stock                                    1            -- 
Common stock                                       9            18
Additional paid-in capital                         280,211      315,036
Accumulated other comprehensive income (loss)      48           (172)
Deficit accumulated during the development stage   (270,250)    (285,871)
Total stockholders' equity                         10,019       29,011
Total liabilities and stockholders' equity         $19,354      $37,989
                                                                 

CONTACT: Investors/Media:
         Paul McBarron,
         (908) 517-7330,
         pmcbarron@cyclacel.com

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