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Cyclacel Reports First Quarter 2013 Financial Results

Cyclacel Reports First Quarter 2013 Financial Results

Conference Call Scheduled on May 13, 2013 at 4:30 p.m. Eastern Time

BERKELEY HEIGHTS, N.J., May 13, 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 first quarter ended March 31, 2013.

The net loss for the first quarters of 2013 and 2012 was $3.1 million and $3.0
million, respectively. As of March 31, 2013, cash and cash equivalents totaled
$14.1 million, which does not include $5.5 million received in April 2013
related to a non-dilutive transaction as detailed below. The Company's net
loss applicable to common stockholders for the first quarter of 2013 was $11.6
million, which includes a one-time non-cash charge of approximately $8.4
million of deemed dividend on convertible exchangeable preferred shares, or
$1.18 per basic and diluted share, compared to a net loss applicable to common
stockholders of $3.1 million or $0.40 per basic and diluted share for the
first quarter of 2012.

"We continued to make progress in our SEAMLESS pivotal, Phase 3 study of
sapacitabine as frontline treatment in elderly patients with acute myeloid
leukemia (AML) having surpassed during the quarter one third of the required
enrollment. We are excited that the updated survival data from our Phase 2
study of sapacitabine in older patients with myelodysplastic syndromes (MDS)
after treatment failures of hypomethylating agents continue to be impressive
and nearly double the expected median overall survival," said Spiro Rombotis,
Cyclacel's President and Chief Executive Officer. "We are also encouraged by
the responses seen from the ongoing Phase 1 study of the sequential
administration of sapacitabine and seliciclib in patients with advanced solid
tumors who carry BRCA mutations. We are pleased to have our data from this
sapacitabine and seliciclib study highlighted at an American Association of
Cancer Research (AACR) press conference regarding major developments reported
during the AACR Annual Meeting. In addition, the $ 5.5 million payment for the
sale of four Cyclacel romidepsin-related patents and dismissal of the related
litigation will allow us to concentrate on the development of our pipeline. We
look forward to reporting updated data from our ongoing studies."

Business Highlights

  oAnnounced updated median overall survival data from an ongoing,
    multicenter, Phase 2 randomized trial of oral sapacitabine in older
    patients with intermediate-2 or high-risk MDS after treatment failure of
    front-line hypomethylating agents, such as azacitidine and/or decitabine.
    Median overall survival to date for all 63 patients treated is
    approximately 9 months. Median overall survival for each of the three
    randomization schedules is approximately 10 months for Arm G, 10 months
    for Arm H and 8 months for Arm I. The 30-day mortality for all patients is
    5%.
    
  oReported at the 104th Annual Meeting of the AACR, updated data from an
    open label, single arm, Phase 1 escalation trial of the Company's
    sapacitabine, a nucleoside analogue, and seliciclib, a cyclin-dependent
    kinase (CDK) inhibitor, as an all-oral, sequentially-administered regimen
    in heavily-pretreated patients with advanced solid tumors. To date, 38
    patients with incurable solid tumors and adequate organ function have been
    enrolled, 16 of which were found to be BRCA mutation carriers. Four
    patients with BRCA-deficient, breast, ovarian and pancreatic cancers
    achieved confirmed partial responses with promising durability, with the
    longest lasting more than 78 weeks. Stable disease of 12 weeks or more was
    observed in eight additional patients, including two with BRCA-deficient,
    ovarian and breast cancers, lasting 64 weeks and 21 weeks, respectively.
    The AACR Annual Meeting Program Committee selected this study for
    inclusion at a press conference highlighting major developments reported
    during the AACR's 104^th Annual Meeting.
    
  oReceived $5.5 million from Celgene Corporation ("Celgene") for the sale of
    four Cyclacel romidepsin-related patents to Celgene and dismissal of all
    claims in the related patent litigation.
    
  oIssued U.S. Patent 8,349,792 and European Patent 2,101,790 providing
    exclusivity until 2029 and 2027 respectively. Both patents include claims
    to combination treatment of sapacitabine with HDAC (histone deacetylase)
    inhibitors, compositions comprising sapacitabine and HDAC inhibitors, and
    methods of treating various cancers with such compositions, including
    leukemias, lymphomas and lung cancer.
    
  oIssued an aggregate 1,513,653 common shares in exchange for an aggregate
    792,460 preferred shares.

First Quarter 2012 Financial Results

Research and Development Expenses

Research and development expenses in the first quarter of 2013 were $1.6
million compared to $1.3 million for the same period in 2012 with the increase
of $0.3 million primarily due to clinical trial and manufacturing costs.

General and Administrative Expenses

Total general and administrative expenses for the first quarter of 2013 were
$2.7 million, compared to $1.8 million for the same period in 2012 with the
increase of $0.9 million primarily related to professional and consultancy
costs including legal fees.

Other

During the first quarter of 2013, issued an aggregate 1,513,653 common shares
in exchange for an aggregate 792,460 preferred shares. As a result of these
transactions, deemed dividends totaling approximately $8.4 million were
charged to the consolidated statement of operations as a one-time, non-cash
expense. During the first quarter of 2013, issued 650,000 common shares to an
institutional investor in consideration for aggregate proceeds of
approximately $3.4 million.

Cash and Cash Equivalents

As of March 31, 2013, Cyclacel's cash and cash equivalents were $14.1 million
compared to $16.4 million as of December 31, 2012. The Company's cash and cash
equivalents do not include the subsequent receipt of $5.5 million for the sale
of four Cyclacel romidepsin-related patents to Celgene. The Company expects
that its cash resources are sufficient to meet anticipated working capital
needs and fund on-going sapacitabine clinical trials for at least the next
twelve months.

Cyclacel's Goals for 2013

  oContinue enrollment in the SEAMLESS pivotal Phase 3 study of sapacitabine
    in AML;
  oReport upcoming DSMB reviews of SEAMLESS;
  oReport updated Phase 2 sapacitabine data in MDS after treatment failure of
    hypomethylating agents;
  oAnnounce registration-directed, clinical development plan for sapacitabine
    in MDS after treatment failure of hypomethylating agents; and
  oReport updated data from the Phase 1 study of sapacitabine and seliciclib
    in patients with advanced solid tumors, including BRCA carriers.

Conference call and Webcast Information:

Cyclacel will conduct a conference call on May 13, 2013 at 4:30 p.m. Eastern
Time to review the first 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 70230723

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 BRCA 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
(Unaudited)
                                                             
                                                             
                                                                Period from
                                         Three Months Ended     August 13,
                                        March 31,              1996
                                                                (inception) to
                                                                March 31
                                        2012       2013        2013
Revenues:                                                     
Collaboration and research and           $ —        $ —         $3,100
development revenue
Grant revenue                           —         212         3,929
Total revenues                          —          212         7,029
Operating expenses:                                           
Research and development                1,347      1,580       193,971
Selling, general and administrative     1,768      2,683       92,094
Goodwill and intangible impairment       —         —          2,747
Restructuring costs                     —         —          2,634
Total operating expenses                 3,115      4,363       291,446
Operating loss                          (3,115)    (4,051)     (284,417)
Other income (expense):                                       
Costs associated with aborted 2004 IPO  —          —           (3,550)
Payment under guarantee                 —          —           (1,652)
Non-cash consideration with stock        —          —           (423)
purchase agreement
Change in valuation of Economic Rights  (56)       570         547
Change in valuation of other liabilities 42         —           6,378
measured at fair value
Foreign exchange (losses)/gains          114        120         (3,885)
Interest income                         6          1           13,748
Interest expense                        —         —          (4,567)
Other income                            47         4           81
Total other income (expense)             153        695         6,677
Loss from continuing operations before   (2,962)    (3,356)     (277,740)
taxes
Income tax benefit                      168        258         20,053
Net loss from continuing operations      (2,794)    (3,098)     (257,687)
Discontinued operations:                                      
(Loss) income from discontinued
operations, net of tax of $0 and $10 for (161)      16          (12,130)
the three months ended March 31, 2012
and 2013, respectively
Net loss                                 (2,955)    (3,082)     (269,817)
Dividends on preferred ordinary shares  —          —           (38,123)
Deemed dividend on convertible           —         (8,366)     (11,881)
exchangeable preferred shares
Dividend on convertible exchangeable     (182)      (122)       (4,507)
preferred shares
Net loss applicable to common            $(3,137) $(11,570) $(324,328)
shareholders
Net loss per share, continuing           $(0.38)  $(1.18)   
operations– Basic and diluted
Net income (loss) per share,
discontinued operations– Basic and      $(0.02)  $ (0.00)  
diluted
Net loss per share – Basic and diluted  $(0.40)  $(1.18)   
Weighted average common shares           7,823,089  9,790,474   
outstanding

                                                                   
                                                                   
CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s, except share amounts)
(Unaudited)
                                                                   
                                                        As of       As of
                                                         December 31 March 31
                                                        2012        2013
ASSETS                                                              
Current assets:                                                     
Cash and cash equivalents                               $16,412     $14,139
Prepaid expenses and other current assets               1,599       2,056
Current assets of discontinued operations               861         835
Total current assets                                     18,872      17,030
Property, plant and equipment (net)                     129         184
Long-term assets of discontinued operations             353         272
Total assets                                             $19,354     $17,486
                                                                   
LIABILITIES AND STOCKHOLDERS' EQUITY                                
Current liabilities:                                                
Accounts payable                                        $2,259      $2,825
Accrued liabilities and other current liabilities       5,601       3,534
Economic rights                                         1,120       550
Other liabilities measured at fair value                20          20
Current liabilities of discontinued operations          335         323
Total current liabilities                                9,335       7,252
Total liabilities                                        9,335       7,252
Stockholders' equity:                                               
Preferred stock, $0.001 par value; 5,000,000 shares
authorized at December 31, 2012 and March 31, 2013;
1,213,142 and 420,682 shares issued and outstanding at
December 31, 2012 and March 31, 2013, respectively.      1           —
Aggregate preference in liquidation of $14,436,390 and
$5,006,116 at December 31, 2012 and March 31, 2013,
respectively
Common stock, $0.001 par value; 100,000,000 shares
authorized at December 31, 2012 and March 31, 2013;      9           11
7,745,780 and 10,881,780 shares issued and outstanding
at December 31, 2012 and March 31, 2013, respectively
Additional paid-in capital                              280,211     292,114
Accumulated other comprehensive loss                    48          (193)
Deficit accumulated during the development stage        (270,250)   (281,698)
Total stockholders' equity                              10,019      10,234
Total liabilities and stockholders' equity              $19,354     $17,486

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

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