Cyclacel Reports Second Quarter 2013 Financial Results

Cyclacel Reports Second Quarter 2013 Financial Results

Conference Call Scheduled on August 14, 2013 at 4:30 p.m. Eastern Time

BERKELEY HEIGHTS, N.J., Aug. 14, 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
second quarter ended June 30, 2013.

The net income for the second quarter of 2013 was $1.5 million and the net
loss for the second quarter of 2012 was $3.6 million. As of June 30, 2013,
cash and cash equivalents totaled $33.7 million. The Company's net income
applicable to common shareholders for the second quarter of 2013 was $1.4
million, which includes $5.5 million of income received in April 2013 related
to a transaction as detailed below, or $0.10 per basic and diluted share,
compared to a net loss applicable to common shareholders of $3.8 million or
$0.45 per basic and diluted share for the second quarter of 2012.

"This quarter has been notable as we recorded a net income result,
significantly strengthened our balance sheet and made progress in the clinic.
We added approximately $24 million to our cash through an underwritten
offering and the sale of four Cyclacel romidepsin-related patents. We have
enrolled over 40% of the required patients in SEAMLESS, our pivotal, Phase 3
study of sapacitabine as frontline treatment in elderly patients with acute
myeloid leukemia (AML)," said Spiro Rombotis, Cyclacel's President and Chief
Executive Officer. "We have also signed an agreement with a contract research
organization to expand SEAMLESS into Western Europe, which we anticipate will
approximately double the number of enrolling sites. Following recent capital
inflows, we expect our existing cash to fund us beyond the planned completion
of the SEAMLESS study."

"In other programs 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 doubled the expected median overall survival.We expect to report the
final results from this study at an upcoming medical conference. We were also
pleased to have our data from the ongoing Phase 1 study of the sequential
administration of sapacitabine and seliciclib in patients with advanced solid
tumors who carry BRCA mutations highlighted at an American Association of
Cancer Research (AACR) press conference regarding major developments reported
during the AACR Annual Meeting.In addition, dismissal of the litigation with
Celgene will allow us to concentrate on the development of our pipeline.We
look forward to reporting updated data from our other ongoing studies," added
Mr. Rombotis.

Business Highlights

  *Announced 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%.
  *Reported 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.
  *Received $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.
  *Closed an underwritten offering for net proceeds of approximately $19.0
    million after deduction of offering expenses.
  *Announced that seliciclib, our 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.

Second Quarter 2013 Financial Results

Research and Development Expenses

Research and development expenses in the second quarter of 2013 were $2.6
million compared to $1.7 million for the same period in 2012 with the increase
of $0.9 million primarily due to clinical trial and manufacturing costs.

General and Administrative Expenses

Total general and administrative expenses for the second quarter of 2013 were
$1.8 million, compared to $2.1 million for the same period in 2012 with the
decrease of $0.3 million primarily related to professional and consultancy
costs including legal fees.

Cash and Cash Equivalents

As of June 30, 2013, Cyclacel's cash and cash equivalents were $33.7 million
compared to $16.4 million as of December 31, 2012. The increase in cash and
cash equivalents was due primarily to net proceeds of $19.0 million from the
underwritten offering and a net $5.0 million from the sale of four Cyclacel
patents partially offset by net spending on operating activities of $6.7
million.

Cyclacel's Key Goals for the next 12 Months

  oContinue enrollment in the SEAMLESS pivotal Phase 3 study of sapacitabine
    in AML;
  oReport upcoming DSMB reviews of SEAMLESS for safety every 100 patients and
    for futility when 212 pooled events have been observed;
  oReport primary endpoint Phase 2 sapacitabine survival 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 August 14, 2013 at 4:30 p.m.
Eastern Time to review the second 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 27460381

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
                                                                  August 13,
                    Three Months Ended    Six Months Ended       1996
                     June 30,              June 30,               (inception)
                                                                  to
                                                                  June 30,
                    2012       2013       2012       2013        2013
Revenues:                                                     
Collaboration and
research and         $ —        $ —        $ —        $ —         $3,100
development revenue
Grant revenue       26         264        26         476         4,193
Total revenues      26         264        26         476         7,293
Operating expenses:                                           
Research and         1,717      2,631      3,064      4,211       196,602
development
General and          2,121      1,787      3,889      4,470       93,881
administrative
Goodwill and
intangibles          —         —         —         —          2,747
impairment
Other restructuring  —         —         —         —          2,634
costs
Total operating      3,838      4,418      6,953      8,681       295,864
expenses
Operating loss      (3,812)    (4,154)    (6,927)    (8,205)     (288,571)
Other income                                                  
(expense):
Costs associated
with aborted 2004    —          —          —          —           (3,550)
IPO
Payment under        —          —          —          —           (1,652)
guarantee
Non-cash
consideration
associated with      —          —          —          —           (423)
stock purchase
agreement
                                                             
Change in valuation  146        —         90         570         547
of Economic Rights
Change in valuation
ofliabilities       8          —         50         —          6,378
measured at fair
value
Foreign exchange     117        (101)      231        19          (3,986)
gain (loss)
Interest income     6          3          12         4           13,751
Interest expense    —         —         —         —          (4,567)
Other income, net   29         5,500      76         5,504       5,581
Total other income   306        5,402      459        6,097       12,079
(Loss) income from
continuing           (3,506)    1,248      (6,468)    (2,108)     (276,492)
operations before
taxes
Income tax benefit,  127        230        295        488         20,283
net
Net (loss) income
from continuing      (3,379)    1,478      (6,173)    (1,620)     (256,209)
operations
Discontinued                                                  
operations:
(Loss) income from
discontinued         (198)      24         (359)      50          (11,759)
operations
Income tax on
discontinued         —         (10)       —         (20)        (357)
operations
Net (loss) income
from discontinued    (198)      14         (359)      30          (12,116)
operations
Net (loss) income    (3,577)    1,492      (6,532)    (1,590)     (268,325)
Dividends on
preferred ordinary   —          —          —          —           (38,123)
shares
Deemed dividend on
convertible          —         —         —         (8,366)     (11,881)
exchangeable
preferred shares
                                                             
Dividend on
convertible          (182)      (63)       (364)      (185)       (4,570)
exchangeable
preferred shares
Net (loss) income
applicable to common $(3,759) $1,429     $(6,896) $(10,141) $(322,899)
shareholders
                                                             
Basic earnings per
share of common                                               
stock:
Net (loss) income
per share,           $(0.42)  $0.10      $(0.80)  $(0.86)   
continuing
operations
Net (loss) income
per share,           $(0.02)  $0.00      $(0.04)  $0.00       
discontinued
operations
Net (loss) income
applicable to common $(0.45)  $0.10      $(0.85)  $(0.86)   
shareholders
                                                             
Diluted earnings per
share of common                                               
stock:
Net (loss) income
per share,           $(0.42)  $0.10      $(0.80)  $(0.86)   
continuing
operations
Net (loss) income
per share,           $(0.02)  $0.00      $(0.04)  $0.00       
discontinued
operations
Net (loss) income
applicable to common $(0.45)  $0.10      $(0.85)  $(0.86)   
shareholders
                                                             
Weighted average
shares of common                                              
stock outstanding:
Basic               8,428,154  13,855,442 8,125,621  11,849,270  
Diluted             8,428,154  13,927,371 8,125,621  11,849,270  


CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In $000s)
(Unaudited)
                                                              
                                                  As of         As of
                                                 December 31, June 30,
                                                  2012          2013
ASSETS                                                         
Current assets:                                                
Cash and cash equivalents                        $16,412       $33,668
Prepaid expenses and other current assets        1,599         2,670
Current assets of discontinued operations        861           817
Total current assets                              18,872        37,155
Property, plant and equipment (net)              129           169
Long-term assets of discontinued operations      353           186
Total assets                                      $19,354       $37,510
                                                              
LIABILITIES AND STOCKHOLDERS' EQUITY                            
Current liabilities:                                           
Accounts payable                                 $2,259        $2,437
Accrued and other current liabilities            5,601         3,797
Economic Rights measured at fair value           1,120         —
Other liabilities measured at fair value         20            20
Current liabilities of discontinued operations   335           325
Total current liabilities                         9,335         6,579
Total liabilities                                 9,335         6,579
Stockholders' equity:                                          
Preferred stock                                  1             —
Common stock                                     9             17
Additional paid-in capital                       280,211       311,125
Accumulated other comprehensive income (loss)    48            (5)
Deficit accumulated during the development stage (270,250)     (280,206)
Total stockholders' equity                       10,019        30,931
Total liabilities and stockholders' equity       $19,354       $37,510

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

Cyclacel Pharmaceuticals logo
 
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