Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2012 Financial Results

Cyclacel Pharmaceuticals Reports Fourth Quarter and Full Year 2012 Financial
Results

Conference Call Scheduled March 27, 2013 at 4:30 p.m. Eastern Time

BERKELEY HEIGHTS, N.J., March 27, 2013 (GLOBE NEWSWIRE) -- Cyclacel
Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the
"Company") announced today its financial results and business highlights for
the fourth quarter and full year 2012. The Company's net loss applicable to
common stockholders for the fourth quarter of 2012 was $4.9 million, or $0.59
per basic and diluted share, compared to a net loss applicable to common
stockholders of $3.8 million, or $0.50 per basic and diluted share, for the
fourth quarter of 2011. For the year ended December 31, 2012, the Company
reported a net loss applicable to common stockholders of $13.9 million, or
$1.68 per basic and diluted share, compared to a net loss of $16.0 million or
$2.22 per basic and diluted share, for the year ended December 31, 2011. As of
December 31, 2012, cash and cash equivalents totaled $16.4 million.

"In 2012 we continued to make progress with the SEAMLESS Phase 3 study of
sapacitabine in Acute Myeloid Leukemia (AML). At a year-end review the
independent committee overseeing SEAMLESS identified no safety or efficacy
concerns and recommended that the study should continue as planned," said
Spiro Rombotis, President and Chief Executive Officer of Cyclacel.
"Sapacitabine's potential in other indications continues to evolve. Recent
data from a Phase 2 study demonstrated that sapacitabine nearly doubled
expected survival of patients with myelodysplastic syndromes (MDS) after
treatment failure of hypomethylating agents. In a Phase 1 study, sapacitabine,
in combination with Cyclacel's seliciclib, showed antitumor activity in cancer
patients found to be carriers of BRCA mutations. We plan to report updated
data from both on-going studies as soon as mature follow-up is reached. We
have broadened sapacitabine's patent estate with certain claims supporting
market exclusivity to 2030. We continue to prudently manage our cash needs and
have received an aggregate of $4.4 million through our Aspire Capital
agreement and a government grant of $1.9 million supporting development of
CYC065, our second-generation cyclin dependent kinase (CDK) inhibitor."

Fourth Quarter 2012 and Recent Highlights

Sapacitabine in Acute Myeloid Leukemia

  *Randomized as of today 162 patients or approximately 33% of the projected
    number of patients in SEAMLESS.
  *Convened the second meeting of the independent Data Safety Monitoring
    Board (DSMB) of the SEAMLESS, Phase 3, randomized, registration-directed
    study of sapacitabine in elderly patients with AML. The DSMB recommended
    that the study should continue as planned after reviewing available data
    from 119 randomized patients. The DSMB noted that no safety or efficacy
    concerns were identified. SEAMLESS is being conducted under a Special
    Protocol Assessment (SPA) agreement with the U.S. Food and Drug
    Administration (FDA). The DMSB will conduct additional periodic reviews
    and will perform a futility assessment once 212 events are observed.
  *Pooled updated survival data from the Phase 1/2 pilot study and the
    lead-in phase of SEAMLESS evaluating the sequential regimen of
    sapacitabine and decitabine were presented at the 54th American Society of
    Hematology conference. The data demonstrated median overall survival of
    238 days, or approximately 8 months. Forty-six patients with a median age
    of 77 years (range 70-90) were treated with alternating cycles of
    sapacitabine and decitabine. Thirty-three patients (72%) were 75 years or
    older. Sixteen patients (35%) survived 1 year or longer. The number of
    patients alive at 3 months was 38 (83%), 6 months 30 (65%), 12 months 16
    (35%) and 18 months 12 (26%). Among 33 patients (72%) who are 75 years or
    older, median overall survival was 263 days, or approximately 9 months,
    and 1-year survival was 36%.
  *Results published in The Lancet Oncology showed promising response rate
    and overall survival observed in elderly patients aged 70 years or older
    with newly diagnosed AML or AML in first relapse enrolled in a Phase 2
    study of single-agent sapacitabine.

Sapacitabine in Myelodysplastic Syndromes

  *Reported results at The Eighth Annual Hematologic Malignancies 2012
    Conference from the Phase 2 randomized trial of sapacitabine in older
    patients with intermediate-2 or high-risk MDS after treatment failure of
    front-line hypomethylating (HMA) agents, such as azacitidine and/or
    decitabine. The data showed that sapacitabine nearly doubled expected
    survival in this population. The study enrolled 63 patients aged 60 years
    or older with intermediate-2 or high-risk MDS. Median overall survival for
    all patients in the three arms was 252 days (approximately 8 months).
    Median overall survival for 41 of 63 patients with 10% to 19% blasts in
    their bone marrow was 274 days or approximately 9 months. Twenty-two
    percent of patients were still alive.

Sapacitabine in Solid Tumors

  *Reported at the 2012 American Society of Clinical Oncology (ASCO) Annual
    Meeting interim data from an open label, single arm, Phase 1 escalation
    trial of sapacitabine, in combination with seliciclib, Cyclacel's CDK
    inhibitor, as an orally-administered sequential treatment regimen in
    heavily-pretreated patients with advanced solid tumors. The regimen showed
    early evidence of antitumor activity in particular in cancer patients
    found to be carriers of BRCA mutations.

Other highlights

  *The personalized medicine potential of sapacitabine was presented at the
    8th National Cancer Research Institute Cancer Conference. Translational
    findings demonstrated the potential for sapacitabine to be used alone or
    in combination to treat homologous recombination repair (HRR) defective
    tumors, such as cancers with ATM or BRCA defects.
  *Issued U.S. Patent 8,349,792 and European Patent 2,101,790. Both patents
    include claims to combination treatment of sapacitabine with HDAC (histone
    deacetylase) inhibitors. The patents provide exclusivity until June 2029
    and December 2027 respectively. The patents include claims to combinations
    of sapacitabine and HDAC inhibitors, pharmaceutical compositions
    comprising sapacitabine and HDAC inhibitors, and methods of treating
    various cancers including leukemias, lymphomas and lung cancer with such
    compositions.
  *Issued U.S. Patent 8,124,593 which grants claims to a specified method of
    administration of sapacitabine with certain claims supporting market
    exclusivity to 2030 adding to existing composition of matter patents.
  *Received a grant award 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, CDK inhibitor.
  *Entered into a common stock purchase agreement with Aspire Capital Fund,
    LLC (Aspire). Aspire committed to purchase up to $20 million of Cyclacel's
    common stock from time to time as directed by Cyclacel over two years at
    formula prices based on the market price at the time of each sale.
  *Entered into separate Securities Exchange Agreements with two stockholders
    pursuant to which the Company issued an aggregate 748,455 shares of its
    common stock to the stockholders in exchange for delivery to the Company
    of an aggregate 417,003 shares of the Company's 6% Exchangeable
    Convertible Preferred Stock.
  *Issued a court order on March 6, 2013 by the United States District Court
    for the District of Delaware ordering a Stipulation and Order For Stay as
    to all pending dates on the court's calendar for a period of thirty (30)
    days in the pending litigation between Cyclacel Pharmaceuticals, Inc. and
    Celgene Corporation regarding four of the Company's patents claiming the
    use of romidepsin injection in T-cell lymphomas and Celgene's use and
    administration of its ISTODAX® (romidepsin for injection) product. The
    stay relates to all proceedings, including the 'Markman' (or claim
    construction) hearing previously scheduled for March 14, 2013.

Cyclacel's Key Milestones for 2013

  *Continue enrollment in the SEAMLESS pivotal, Phase 3 study in AML;
  *Report upcoming DSMB reviews of SEAMLESS;
  *Report Phase 2, updated survival data for sapacitabine in MDS following
    treatment failure of hypomethylating agents;
  *Announce registration-directed, clinical development plan for sapacitabine
    in MDS following treatment failure of hypomethylating agents;
  *Report updated Phase 1 sapacitabine and seliciclib combination data in
    patients with solid tumors;
  *Report outcome of 'Markman' patent construction hearing on romidepsin
    intellectual property litigation.

Financial Highlights

For the fourth quarter of 2012, Cyclacel reported a net loss applicable to
common stockholders of $4.9 million, or $0.59 per basic and diluted share,
compared to a net loss applicable to common stockholders of $3.8 million, or
$0.50 per basic and diluted share, for the fourth quarter of 2011. Total
research and development (R&D) expenses in the fourth quarter of 2012 were
$2.0 million compared to $2.2 million in the fourth quarter of 2011. Total
general and administrative expenses (G&A) amounted to $2.7 million in the
fourth quarter of 2012 compared to $1.4 million for the fourth quarter of
2011. The increase is primarily due to an increase in legal, consultancy and
other professional costs and reduced stock-based compensation costs. Total
other expense was $0.4 million in the fourth quarter of 2012, which was
primarily due to a non-cash consideration related to the stock purchase
agreement with Aspire, compared to no expense in 2011.

Cash and cash equivalents totaled $16.4 million as of December 31, 2012.
Cyclacel expects that its cash resources are sufficient to meet anticipated
short-term working capital needs and fund on-going sapacitabine clinical
trials for at least the next twelve months.

Conference call and Webcast Information:

Cyclacel will conduct a conference call on March 27, 2013 at 4:30p.m. Eastern
Time to review the fourth quarter and year-end 2012 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 19638297

For the live and archived webcast, please visit the Corporate Presentations
and Events 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 sapacitabine

Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently
being studied in SEAMLESS, an ongoing, Phase 3, registration-directed trial in
elderly patients aged 70 years or older with newly diagnosed AML who are not
candidates for or have refused induction chemotherapy. Sapacitabine is also
the subject of Phase 2 trials in patients with hematological malignancies,
including AML, myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma
(CTCL), chronic lymphocytic leukemia and small lymphocytic lymphoma, and
non-small cell lung cancer (NSCLC), and a Phase 1 trial in combination with
seliciclib in patients with advanced solid tumors. Sapacitabine acts through a
novel DNA single-strand breaking mechanism, leading to production of DNA
double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs
cause cell death. Repair of sapacitabine-induced DSBs is dependent on the
homologous recombination DNA repair (HRR) pathway. Both sapacitabine and
CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in
preclinical studies.

Over 650 patients have received sapacitabine in clinical studies in patients
with AML, MDS, CTCL, NSCLC, hematological malignancies and solid tumors. At
the 2012 ASH Annual Meeting, data from the pilot study and lead-in phase of
SEAMLESS showed promising response rate, overall survival and low 30-day and
60-day mortality in elderly patients with AML aged 70 years or older receiving
sapacitabine alternating with decitabine. Data, presented at The Eighth Annual
Hematologic Malignancies 2012 Conference, from an ongoing, multicenter, Phase
2 randomized trial of single-agent oral sapacitabine capsules 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, showed sapacitabine nearly doubled expected
survival of elderly patients with MDS after front-line therapy failure.
Results from a randomized Phase 2, single-agent study of sapacitabine,
including promising 1-year survival in elderly patients with AML aged 70 years
or older, were published in The Lancet Oncology in November 2012. In a Phase 1
study, sapacitabine, in combination with Cyclacel's seliciclib, showed
antitumor activity in cancer patients found to be carriers of BRCA mutations.
The FDA and the European Medicines Agency have designated sapacitabine as an
orphan drug for the treatment of both AML and MDS. Sapacitabine is part of
Cyclacel's pipeline of small molecule drugs designed to target and stop
uncontrolled cell division.

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. 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 2013 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
ISTODAX® is a trademark of Celgene Corporation.


CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
(Unaudited)

                                                                  Period from
                                                                  August 13,
                    Three Months Ended    Year Ended              1996
                    December 31,          December 31,            (inception)
                                                                  to
                                                                  December 31,
                   2011       2012       2011        2012        2012
Revenues:                                                     
Collaboration and
research and        $—       $—       $—        $—        $3,100
development revenue
Grant revenue       —        5         —          69          3,717
Total revenues      —         5         —           69          6,817
Operating expenses:                                           
Research and        2,201     1,996     9,206       6,592       192,391
development
Selling, general    1,406     2,663     6,542       8,580       89,411
and administrative
Goodwill and
intangible          —        —        —          —          2,747
impairment
Restructuring costs —        —        —          —          2,634
Total operating     3,607     4,659     15,748      15,172      287,183
expenses
Operating loss      (3,607)   (4,654)   (15,748)    (15,103)    (280,366)
Other income                                                  
(expense):
Costs associated
with aborted 2004   —         —         —           —           (3,550)
IPO
Payment under       —         —         —           —           (1,652)
guarantee
Non-cash
consideration with  —         (423)     —           (423)       (423)
stock purchase
agreement
Change in valuation —         (50)      —           (23)        (23)
of Economic Rights
Change in valuation
of other
liabilities         (34)    —         609         51          6,378
measured at fair
value
Foreign exchange    (15)     55        (74)        292         (4,005)
(losses)/gains
Interest income     12       5         45         22          13,747
Interest expense    —        —        —          —          (4,567)
Other income        —        —       —          77          77
Total other income  (37)      (413)    580         (4)         5,982
(expense).
Loss from
continuing          (3,644)   (5,067)   (15,168)    (15,107)    (274,384)
operations before
taxes
Income tax benefit  122      637       565        1,351       19,795
Net loss from
continuing          (3,522)   (4,430)   (14,603)    (13,756)    (254,589)
operations
Discontinued                                                  
operations:
(Loss) income from
discontinued
operations, net of
tax of $0
for the three
months and year     (136)     (334)     (640)       570         (12,146)
ended December 31,
2011 and
$337 for the three
months and year
endedDecember 31,
2012
Net loss            (3,658)   (4,764)   (15,243)    (13,186)    (266,735)
Dividends on
preferred ordinary  —         —         —           —           (38,123)
shares
Deemed dividend on
convertible         —        —        —          —         (3,515)
exchangeable
preferred shares
Dividend on
convertible         (182)    (182)   (728)      (728)      (4,385)
exchangeable
preferred shares
Net loss applicable
to common           $(3,840) $(4,946) $ (15,971) $ (13,914) $(312,758)
shareholders
Net loss per share,
continuing          $(0.48)  $(0.55)  $(2.13)   $(1.75)   
operations– Basic
and diluted
Net income (loss)
per share,
discontinued        $(0.02)  $(0.04)  $(0.09)   $0.07     
operations– Basic
and diluted
Net loss per share  $(0.50)  $(0.59)  $(2.22)   $(1.68)   
– Basic and diluted
Weighted average
common shares       7,673,096 8,429,269 7,185,877  8,291,802  
outstanding



CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s, except share amounts)
(Unaudited)

                                                      As of       As of
                                                       December 31 December 31
                                                      2011        2012
ASSETS                                                            
Current assets:                                                   
Cash and cash equivalents                              $24,449   $16,412
Prepaid expenses and other current assets              1,069      1,599
Current assets of discontinued operations              313        861
Total current assets                                   25,831     18,872
Property, plant and equipment (net)                    167        129
Long-term assets of discontinued operations            —          353
Total assets                                           $25,998   $19,354
                                                                 
LIABILITIES AND STOCKHOLDERS' EQUITY                              
Current liabilities:                                              
Accounts payable                                       $1,717    $2,259
Accrued liabilities and other current liabilities      4,183      5,601
Economic rights                                        —          1,120
Other liabilities measured at fair value               71         20
Current liabilities of discontinued operations         527        335
Total current liabilities                              6,498      9,335
Total liabilities                                      6,498      9,335
Stockholders' equity:                                             
Preferred stock, $0.001 par value; 5,000,000 shares
authorized at December 31, 2011 and December 31, 2012;
1,213,142 shares issued and outstanding at December    1          1
31, 2011 and December 31, 2012. Aggregate preference
in liquidation of $13,708,505 and $14,436,390 at
December 31, 2011 and December 31, 2012, respectively
Common stock, $0.001 par value; 100,000,000 shares
authorized at December 31, 2011 and December 31, 2012;
7,745,780 and 8,686,484 shares issued and outstanding  8          9
at December 31, 2011 and December 31, 2012,
respectively
Additional paid-in capital                             276,498    280,211
Accumulated other comprehensive loss                   57         48
Deficit accumulated during the development stage       (257,064)  (270,250)
Total stockholders' equity                             19,500     10,019
Total liabilities and stockholders' equity             $25,998   $19,354

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

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