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REPORTS 2ND QUARTER 2016 FINANCIAL RESULTS

Key Takeaway: CYCLACEL PHARMACEUTICALS REPORTS 2ND QUARTER 2016 FINANCIAL RESULTS Call Scheduled August 10, 2016 at 4:30 p.m. EDT BERKELEY HEIGHTS, N.J., Aug. 10, 2016 -- Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC) (Nasdaq: CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical compa

Full Press Release Details

CYCLACEL PHARMACEUTICALS
REPORTS 2ND QUARTER 2016 FINANCIAL RESULTS
Call Scheduled August 10, 2016 at 4:30 p.m. EDT
BERKELEY HEIGHTS, N.J., Aug. 10,
2016 -- 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 financial results and business highlights for the second quarter ended June 30, 2016.
The Company's net loss applicable
to common shareholders for the second quarter ended June 30, 2016 was $3.0 million, or $1.01 per basic and diluted share, compared
to net loss applicable to common shareholders of $3.4 million, or $1.19 per basic and diluted share for the second quarter ended
June 30, 2015. As of June 30, 2016, cash and cash equivalents totaled $15.9 million.
"Subsequent to the end of the
quarter, we achieved a key milestone in our acute myeloid leukemia (AML) SEAMLESS Phase 3 study," said Spiro Rombotis, President
and Chief Executive Officer of Cyclacel. "The required number of events has been reached and preparations for final analysis
and reporting of SEAMLESS outcomes are underway. Over the next several weeks, we will complete data cleaning and validation operations
after which the database will be transferred to our statistical analysis vendor. We will subsequently report outcomes for the primary
(overall survival) and secondary endpoints and determination of submissibility of the SEAMLESS data set to regulatory authorities
in Europe and the United States.
In our DNA damage response program,
durable antitumor activity was reported at an oral presentation at the 2016 ASCO Annual Meeting with a combination of sapacitabine
and seliciclib, our CDK2/9 inhibitor, in heavily pretreated patients with breast, ovarian and pancreatic cancers who tested positive
for BRCA mutations. A disease control rate of 35.6% was observed, with ongoing responding patients achieving treatment durations
exceeding 1 and 4.7 years, respectively. We continue to enroll patients with solid tumors in a first-in-human, Phase 1 study of
CYC065, our second-generation CDK2/9 inhibitor."
DNA damage response program
Cyclin dependent kinase (CDK)
KEY UPCOMING MILESTONES
DNA damage response program
CDK Inhibitor Program
Sapacitabine in myelodysplastic
SECOND QUARTER 2016 FINANCIAL RESULTS
Revenue for the three months ended
June 30, 2016 was $0.2 million, compared to $0.3 million for the same period of the previous year. The revenue is related to previously
awarded grants from the UK government being recognized over the period to progress CYC065 to IND and complete IND-directed preclinical
development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor.
Research and Development Expenses
Research and development expenses
were $2.6 million for the three months ended June 30, 2016 and $2.6 million for the three months ended June 30, 2015.
General and Administrative Expenses
General and administrative expenses
were $1.3 million for the three months ended June 30, 2016 and $1.3 million for the three months ended June 30, 2015.
Based on current plans, the Company
estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs through the
first quarter of 2018.
CONFERENCE CALL AND WEBCAST INFORMATION:
Cyclacel will conduct a conference
call on August 10, 2016 at 4:30 p.m. Eastern Time to review the second quarter 2016 results. Conference call and webcast details
Conference call information:
US/Canada call: (877) 493-9121/ international call: (973) 582-2750
US/Canada archive: (800) 585-8367 / international archive:
Code for live and archived conference call is 59985383
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 Cyclacel Pharmaceuticals,
Cyclacel Pharmaceuticals is a clinical-stage
biopharmaceutical company using cell cycle control and DNA damage response biology to develop innovative, targeted medicines for
cancer and other proliferative diseases. The SEAMLESS randomized Phase 3 trial of sapacitabine as front-line treatment for AML
in the elderly under an SPA with FDA has completed enrollment. Cyclacel's pipeline includes an oral combination of seliciclib (CDK2/9
inhibitor) and sapacitabine in Phase 1 in advanced solid tumors, including patients with BRCA mutations; sapacitabine in Phase
2 in MDS; and CYC065 (CDK2/9 inhibitor) in Phase 1 in solid tumors and lymphomas with potential utility
based on preclinical data in other hematological malignancies. Cyclacel's strategy is to build a diversified biopharmaceutical
business focused in hematology and oncology based on a pipeline of novel drug candidates. Please visit www.cyclacel.com
for more 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.
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo Partners LLC, Alexander Fudukidis, (646) 942-5632,
Copyright 2016 Cyclacel Pharmaceuticals,
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share
Three Months Ended June 30, Six Months Ended June 30,
2015 2016 2015 2016
Revenues:
Grant revenue $ 296 $ 222 $ 808 $ 361
Operating expenses:
Research and development 2,580 2,637 6,922 5,136
General and administrative 1,333 1,345 2,801 2,729
Total operating expenses 3,913 3,982 9,723 7,865
Operating loss (3,617 ) (3,760 ) (8,915 ) (7,504 )
Other income (expense):
Change in valuation of financial instruments associated with stock purchase agreement (4 ) - (24 ) -
Foreign exchange (loss) gain (195 ) 138 (573 ) 318
Interest income 2 13 3 23
Other income, net 62 18 82 38
Total other income (expense) (135 ) 169 (512 ) 379
Loss before taxes (3,752 ) (3,591 ) (9,427 ) (7,125 )
Income tax benefit 405 626 1,168 1,119
Net loss (3,347 ) (2,965 ) (8,259 ) (6,006 )
Dividend on convertible exchangeable preferred shares (50 ) (50 ) (100 ) (100 )
Net loss applicable to common shareholders $ (3,397 ) $ (3,015 ) $ (8,359 ) $ (6,106 )
Basic and diluted earnings per common share:
Net loss per share - basic and diluted $ (1.19 ) $ (1.01 ) $ (3.32 ) $ (2.05 )
Weighted average common shares outstanding 2,865,707 3,000,192 2,520,897 2,982,508
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In $000s, except share, per share,
and liquidation preference amounts)
December 31, June 30,
2015 2016
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 20,440 $ 15,931
Prepaid expenses and other current assets 4,051 2,762
Current assets of discontinued operations 75 75
Total current assets 24,566 18,768
Property, plant and equipment (net) 198 109
Total assets $ 24,764 $ 18,877
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,940 $ 1,898
Accrued and other current liabilities 3,738 3,592
Current liabilities of discontinued operations 75 75
Total current liabilities 5,753 5,565
Other liabilities 176 150
Total liabilities 5,929 5,715
Total stockholders' equity 18,835 13,162
Total liabilities and stockholders' equity $ 24,764 $ 18,877
Source: Cyclacel Pharmaceuticals, Inc.
Last updated: Aug 10, 2016