þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Delaware
(State or Other Jurisdiction of Incorporation or Organization) |
91-1707622
(I.R.S. Employer Identification No.) |
|
200 Connell Drive
Suite 1500 Berkeley Heights, New Jersey (Address of principal executive offices) |
07922
(Zip Code) |
Title of Each Class | Name of Each Exchange on Which Registered | |
Common Stock, $0.001 par value | The NASDAQ Stock Market LLC | |
Preferred Stock, $0.001 par value | The NASDAQ Stock Market LLC |
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
[Do not check if a smaller reporting company] |
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Exhibit 3.2 | ||||||||
Exhibit 10.13 | ||||||||
Exhibit 10.14 | ||||||||
Exhibit 21 | ||||||||
Exhibit 23.1 | ||||||||
Exhibit 31.1 | ||||||||
Exhibit 31.2 | ||||||||
Exhibit 32.1 | ||||||||
Exhibit 32.2 |
2
(a) | consolidated balance sheets as of March 31, 2009, June 30, 2009, September 30, 2009, December 31, 2009, March 31, 2010, June 30, 2010, and September 30, 2010 and statement of stockholders equity for the year ended December 31, 2009; and |
(b) | Selected Financial Data as of and for the year ended December 31, 2009. |
(a) | restates its consolidated balance sheet as of December 31, 2009 and its statement of stockholders equity for the year ended December 31, 2009; |
(b) | amends its Managements Discussion and Analysis of Financial Condition and Results of Operations (MD&A) as it relates to the year ended December 31, 2009; |
(c) | restates its Selected Financial Data as of and for the year ended December 31, 2009; and |
(d) | restates its unaudited consolidated balance sheets as of March 31, 2009, June 30, 2009, September 30, 2009, March 31, 2010, June 30, 2010, and September 30, 2010. |
3
As of | ||||||||||||||||||||||||||||
March 31, | June 30, | September 30, | December 31, | March 31, | June 30, | September 30, | ||||||||||||||||||||||
2009 | 2009 | 2009 | 2009 | 2010 | 2010 | 2010 | ||||||||||||||||||||||
$000 | $000 | $000 | $000 | $000 | $000 | $000 | ||||||||||||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||||||||||||
Other current liabilities
|
||||||||||||||||||||||||||||
As originally reported
|
578 | 777 | 1,336 | n/a | n/a | n/a | n/a | |||||||||||||||||||||
Adjustment
|
(307 | ) | (614 | ) | (921 | ) | n/a | n/a | n/a | n/a | ||||||||||||||||||
|
||||||||||||||||||||||||||||
As restated
|
271 | 163 | 415 | n/a | n/a | n/a | n/a | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
Accrued and other current
liabilities
|
||||||||||||||||||||||||||||
As originally reported
|
n/a | n/a | n/a | 6,709 | 5,818 | 5,255 | 5,641 | |||||||||||||||||||||
Adjustment
|
n/a | n/a | n/a | (1,228 | ) | (1,443 | ) | (1,032 | ) | (1,213 | ) | |||||||||||||||||
|
||||||||||||||||||||||||||||
As restated
|
n/a | n/a | n/a | 5,481 | 4,375 | 4,223 | 4,428 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
Current liabilities
|
||||||||||||||||||||||||||||
As originally reported
|
8,549 | 10,686 | 9,328 | 9,822 | 9,511 | 8,155 | 7,965 | |||||||||||||||||||||
Adjustment
|
(307 | ) | (614 | ) | (921 | ) | (1,228 | ) | (1,443 | ) | (1,032 | ) | (1,213 | ) | ||||||||||||||
|
||||||||||||||||||||||||||||
As restated
|
8,242 | 10,072 | 8,407 | 8,594 | 8,068 | 7,123 | 6,752 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
Total liabilities
|
||||||||||||||||||||||||||||
As originally reported
|
9,966 | 11,212 | 9,595 | 9,822 | 9,511 | 8,155 | 7,965 | |||||||||||||||||||||
Adjustment
|
(307 | ) | (614 | ) | (921 | ) | (1,228 | ) | (1,443 | ) | (1,032 | ) | (1,213 | ) | ||||||||||||||
|
||||||||||||||||||||||||||||
As restated
|
9,659 | 10,598 | 8,674 | 8,594 | 8,068 | 7,123 | 6,752 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
Additional paid-in capital
|
||||||||||||||||||||||||||||
As originally reported
|
222,886 | 222,932 | 225,864 | 226,881 | 244,991 | 248,314 | 250,466 | |||||||||||||||||||||
Adjustment
|
307 | 614 | 921 | 1,228 | 1,528 | 1,632 | 1,813 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
As restated
|
223,193 | 223,546 | 226,785 | 228,109 | 246,519 | 249,946 | 252,279 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
Deficit accumulated during the development stage
|
||||||||||||||||||||||||||||
As originally reported
|
(207,778 | ) | (214,824 | ) | (217,948 | ) | (222,285 | ) | (227,815 | ) | (234,240 | ) | (238,049 | ) | ||||||||||||||
Adjustment
|
| | | | (85 | ) | (600 | ) | (600 | ) | ||||||||||||||||||
|
||||||||||||||||||||||||||||
As restated
|
(207,778 | ) | (214,824 | ) | (217,948 | ) | (222,285 | ) | (227,900 | ) | (234,840 | ) | (238,649 | ) | ||||||||||||||
|
||||||||||||||||||||||||||||
Total stockholders equity
|
||||||||||||||||||||||||||||
As originally reported
|
15,201 | 8,248 | 7,947 | 4,644 | 17,265 | 14,154 | 12,426 | |||||||||||||||||||||
Adjustment
|
307 | 614 | 921 | 1,228 | 1,443 | 1,032 | 1,213 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
As restated
|
15,508 | 8,862 | 8,868 | 5,872 | 18,708 | 15,186 | 13,639 | |||||||||||||||||||||
|
n/a not applicable |
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
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53
Item 1.
Business
AML in the elderly;
Myelodysplastic syndromes, or MDS; and
Non-small cell lung cancer, or NSCLC.
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In January 2011, we opened enrollment of the SEAMLESS pivotal Phase 3 trial as a
front-line treatment of elderly patients aged 70 years or older with newly diagnosed AML
who are not candidates for intensive induction chemotherapy under an SPA, reached with the
FDA;
In December 2010, we announced one-year survival data for sapacitabine Phase 2 trial for
older patients with MDS refractory to the hypomethylating agents azacitidine and/or
decitabine at the 2010 American Society of Hematology (ASH) annual meeting;
In October 2010, we published preclinical model data demonstrating sapacitabine works
synergistically with histone deacetylase (HDAC) inhibitors to induce tumor cell death in
vitro and in vivo;
In July 2010, we announced that the FDA granted orphan drug designation to our
sapacitabine product candidate for the treatment of both AML and MDS; and
In June 2010, we reported interim response data for the ongoing Phase 2 clinical trial
of sapacitabine in older patients with MDS at the American Society of Clinical Oncology, or
ASCO, meeting.
In December 2010, we announced topline data from the APPRAISE, Phase 2b,
randomized discontinuation, double-blinded, placebo-controlled study of oral
seliciclib capsules as a third line or later treatment in patients with NSCLC
showing no difference in median progression free survival (PFS) between the
seliciclib and placebo arms (48 versus 53 days respectively), but an increase in
median overall survival (OS) favoring seliciclib over placebo (388 versus 218
days);
In December 2010, preclinical data from a Cyclacel collaboration was presented
at the 2010 ASH Annual Meeting demonstrating that CYC065 is cytotoxic at
sub-micromolar concentrations against myeloma cell lines and CD138+ myeloma cells
derived from patients. CYC065 demonstrated antiproliferative activity even in the
presence of the growth stimulatory effects of both cytokines and bone marrow
stromal cells. CYC065 induced apoptosis in myeloma cells as evidenced by the
appearance of cleaved PARP;
In April 2010, preclinical data from a Cyclacel collaboration was presented at
the 2010 Annual Meeting of the American Association of Cancer Research (AACR)
introducing CYC065, Cyclacels oral CDK inhibitor, which has the same target
profile as seliciclib, and showing that CYC065 induced apoptosis in HER2 positive
breast cancer cell lines refractory to trastuzumab (Herceptin
®
). CYC065 was also
shown in preclinical studies to have anticancer activity in AML cell lines,
including those with human mixed-lineage leukemia (MLL) rearrangements, and chronic
lymphocytic leukemia (CLL) cells;
In February 2010, a peer-reviewed journal article demonstrated that seliciclib
reversed resistance to the aromatase inhibitor letrozole (Femara
®
) and inhibited
growth of hormone receptor positive breast cancer cells that had become insensitive
to the effects of letrozole; and
In January 2010, a peer-reviewed journal article demonstrated that seliciclib
was effective against lung cancer cell lines and, in particular, those with
activating mutations in K-RAS and N-RAS proteins.
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Development
Cell Cycle
Program
Indication
Status
Target
Mechanism
Elderly AML
Phase 3 trial on-going
DNA polymerase
G2 and S phase
MDS
Phase 2 randomized trial on-going
DNA polymerase
G2 and S phase
CTCL
Phase 2 randomized trial stopped. Not a company priority
DNA polymerase
G2 and S phase
NSCLC
Phase 2 trial on-going
DNA polymerase
G2 and S phase
Cancer
Phase 1 trial on-going
NSCLC
Phase 2b randomized trial closed to accrual
CDK2, 7, 9
G1/S checkpoint and others
NPC
Phase 2 randomized trial. Lead-in phase only on-going
CDK2, 7, 9
G1/S checkpoint and others
Cancer
Phase 1 trial completed
Aurora kinase & VEGFR2
Mitosis
Cancer
Preclinical
CDK
G1/S checkpoint and others
Cancer
Preclinical
Plk
G2/M checkpoint
Cancer
On hold. Not a company priority
Hdm2
G1/2 phase
Cancer
On hold. Not a company priority
Cyclin binding groove
S phase
Autoimmune & Inflammatory Diseases
Phase 1 trial completed On hold. Not a company priority
CDK
G1/S checkpoint and others
HIV/AIDS
On hold. Not a company priority
CDK
Other
Type 2 Diabetes
On hold. Not a company priority
GSK-3
Other
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The novel, mechanism-targeted cell cycle drugs we are developing are designed to be
highly selective in comparison to conventional chemotherapies, potentially inducing
death in cancer cells while sparing most normal cells which may give rise to fewer
side-effects.
We believe that our sapacitabine is the only orally-available nucleoside analogue
presently being tested in the Phase 3 trial in AML and Phase 2 trial in MDS and
seliciclib is the most advanced orally-available CDK inhibitor currently in Phase 2
trials. We believe that we are well positioned to realize some of the market potential
of such drugs.
Ownership and enforcement of patent rights;
Patent applications covering our own inventions in fields that we consider
important to our business strategy;
License agreements with third parties granting us rights to patents in fields that
are important to our business strategy;
Invention assignment agreements with our employees and consultants;
Non-compete agreements with our key employees and consultants;
Confidentiality agreements with our employees, consultants, and others having
access to our proprietary information;
Standard policies for the maintenance of laboratory notebooks to establish priority
of our inventions;
Freedom to use studies from patent counsel;
Material transfer agreements; and
Trademark protection.
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completion of extensive preclinical laboratory tests, preclinical animal studies
and formulation studies, all performed in accordance with the FDAs good laboratory
practice, or GLP, regulations;
submission to the FDA of an IND application which must become effective before
clinical trials may begin;
performance of adequate and well-controlled clinical trials to establish the safety
and efficacy of the drug candidate for each proposed indication;
submission of a NDA to the FDA;
satisfactory completion of an FDA pre-approval inspection of the manufacturing
facilities at which the product is produced to assess compliance with current good
manufacturing practice GMP, or cGMP, regulations;
FDA review and approval of the NDA prior to any commercial marketing, sale or
shipment of the drug; and
regulation of commercial marketing and sale of drugs.
Phase 1:
The clinical trials are initially conducted in a limited population to
test the drug candidate for safety, dose tolerance, absorption, metabolism,
distribution and excretion in healthy humans or, on occasion, in patients, such as
cancer patients. Phase 1 clinical trials can be designed to evaluate the impact of the
drug candidate in combination with currently approved drugs.
Phase 2:
These clinical trials are generally conducted in a limited patient
population to identify possible adverse effects and safety risks, to determine the
efficacy of the drug candidate for specific targeted indications and to determine dose
tolerance and optimal dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information
prior to beginning larger and more expensive Phase 3 clinical trial.
Phase 3:
These clinical trials are commonly referred to as pivotal clinical trials.
If the Phase 2 clinical trials demonstrate that a dose range of the drug candidate is
effective and has an acceptable safety profile, Phase 3 clinical trials are then
undertaken in large patient populations to further evaluate dosage, to provide
substantial evidence of clinical efficacy and to further test for safety in an
expanded and diverse patient population at multiple, geographically dispersed clinical
trial sites.
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Priority Review.
Under FDA policies, a drug candidate is eligible for priority
review, or review within a six-month time frame from the time a complete NDA is
accepted for filing, if the drug candidate provides a significant improvement compared
to marketed drugs in the treatment, diagnosis or prevention of a disease. We cannot
suggest or in any way guarantee that any of our drug candidates will receive a
priority review designation, or if a priority designation is received, that review or
approval will be faster than conventional FDA procedures, or that the FDA will
ultimately grant drug approval.
Accelerated Approval.
Under the FDAs accelerated approval regulations, the FDA is
authorized to approve drug candidates that have been studied for their safety and
effectiveness in treating serious or life-threatening illnesses, and that provide
meaningful therapeutic benefit to patients over existing treatments based upon either
a surrogate endpoint that is reasonably likely to predict clinical benefit or on the
basis of an effect on a clinical endpoint other than patient survival. In clinical
trials, surrogate endpoints are alternative measurements of the symptoms of a disease
or condition that are substituted for measurements of observable clinical symptoms. A
drug candidate approved on this basis is subject to rigorous post-marketing compliance
requirements, including the completion of Phase 4 or post-approval clinical trials to
validate the surrogate endpoint or confirm the effect on the clinical endpoint.
Failure to conduct required post-approval studies, or to validate a surrogate endpoint
or confirm a clinical benefit during post-marketing studies, will allow the FDA to
withdraw the drug from the market on an expedited basis. All promotional materials for
drug candidates approved under accelerated regulations are subject to prior review by
the FDA. In rare instances the FDA may grant accelerated approval of an NDA based on
Phase 2 data and require confirmatory Phase 3 studies to be conducted after approval
and/or as a condition of maintaining approval. We can give no assurance that any of
our drugs will be reviewed under such procedures.
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Item 1A.
Risk Factors
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delays in securing clinical investigators or trial sites for our clinical
trials;
delays in obtaining institutional review board, or IRB, and other regulatory
approvals to commence a clinical trial;
slower than anticipated rates of patient recruitment and enrollment, or
reaching the targeted number of patients because of competition for patients from
other trials or other reasons;
negative or inconclusive results from clinical trials;
unforeseen safety issues;
uncertain dosing issues may or may not be related to suboptimal pharmacokinetic
and pharmacodynamic behaviors;
approval and introduction of new therapies or changes in standards of practice
or regulatory guidance that render our clinical trial endpoints or the targeting
of our proposed indications obsolete;
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inability to monitor patients adequately during or after treatment or problems
with investigator or patient compliance with the trial protocols;
inability to replicate in large controlled studies safety and efficacy data
obtained from a limited number of patients in uncontrolled trials;
inability or unwillingness of medical investigators to follow our clinical
protocols; and
unavailability of clinical trial supplies.
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we may not be able to control the amount and timing of resources that our
collaborators may devote to the drug candidates;
our collaborators may experience financial difficulties;
we may be required to relinquish important rights such as marketing and
distribution rights;
business combinations or significant changes in a collaborators business
strategy may also adversely affect a collaborators willingness or ability to
complete our obligations under any arrangement;
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a collaborator could independently move forward with a competing drug candidate
developed either independently or in collaboration with others, including our
competitors; and
collaborative arrangements are often terminated or allowed to expire, which
would delay the development and may increase the cost of developing our drug
candidates.
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those discussed in the risk factor which immediately follows;
the fact that the FDA or other regulatory officials may not approve our or our
third party manufacturers processes or facilities; or
the fact that new regulations may be enacted by the FDA or other regulators may
change their approval policies or adoption of new regulations requiring new or
different evidence of safety and efficacy for the intended use of a drug
candidate.
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developing drug candidates;
conducting preclinical and clinical trials;
obtaining regulatory approvals; and
commercializing product candidates.
timing of market introduction, number and clinical profile of competitive
drugs;
our ability to provide acceptable evidence of safety and efficacy;
relative convenience and ease of administration;
cost-effectiveness;
availability of coverage, reimbursement and adequate payment from health
maintenance organizations and other third party payors;
prevalence and severity of adverse side effects; and
other potential advantages over alternative treatment methods.
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fund research and development and clinical trials connected with our research;
fund clinical trials and seek regulatory approvals;
build or access manufacturing and commercialization capabilities;
implement additional internal control systems and infrastructure;
commercialize and secure coverage, payment and reimbursement of our drug
candidates, if any such candidates receive regulatory approval;
maintain, defend and expand the scope of our intellectual property; and
hire additional management, sales and scientific personnel.
the scope, rate of progress and cost of our clinical trials and other research and
development activities;
the costs and timing of seeking and obtaining regulatory approvals;
the costs of filing, prosecuting, defending and enforcing any patent claims and
other intellectual property rights;
the costs associated with establishing sales and marketing capabilities;
the costs of acquiring or investing in businesses, products and technologies;
the effect of competing technological and market developments; and
the payment, other terms and timing of any strategic alliance, licensing or other
arrangements that we may establish.
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be prohibited from selling or licensing any product that we may develop unless
the patent holder licenses the patent to us, which it is not required to do;
be required to pay substantial royalties or grant a cross license to our
patents to another patent holder;
decide to move some of our screening work outside Europe;
be required to pay substantial damages for past infringement, which we may have
to pay if a court determines that our product candidates or technologies infringe
a competitors patent or other proprietary rights; or
be required to redesign the formulation of a drug candidate so it does not
infringe, which may not be possible or could require substantial funds and time.
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disclosure of actual or potential clinical results with respect to product
candidates we are developing;
regulatory developments in both the United States and abroad;
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developments concerning proprietary rights, including patents and litigation
matters;
public concern about the safety or efficacy of our product candidates or
technology, or related technology, or new technologies generally;
concern about the safety or efficacy of our product candidates or technology,
or related technology, or new technologies generally;
public announcements by our competitors or others; and
general market conditions and comments by securities analysts and investors.
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authorize the issuance of preferred stock that can be created and issued by the
Board of Directors without prior stockholder approval, commonly referred to as
blank check preferred stock, with rights senior to those of our common stock;
provide for the Board of Directors to be divided into three classes; and
require that stockholder actions must be effected at a duly called stockholder
meeting and prohibit stockholder action by written consent.
Table of Contents
additions to or departures of our key personnel;
announcements of technological innovations or new products or services by us or
our competitors;
announcements concerning our competitors or the biotechnology industry in
general;
new regulatory pronouncements and changes in regulatory guidelines;
general and industry-specific economic conditions;
changes in financial estimates or recommendations by securities analysts;
variations in our quarterly results;
announcements about our collaborators or licensors; and
changes in accounting principles.
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Item 1B.
Unresolved Staff Comments
Item 2.
Properties
Item 3.
Legal Proceedings
Item 4.
(Removed and Reserved)
Table of Contents
54
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68
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113
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117
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119
120
121
122
123
124
125
126
127
128
129
130
Item 5.
Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
High
Low
$
4.08
$
1.00
$
2.97
$
1.38
$
1.98
$
1.40
$
1.95
$
1.44
$
0.54
$
0.26
$
1.66
$
0.30
$
1.24
$
0.79
$
1.69
$
0.75
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Period from
August 13,
1996
(inception) to
Years Ended December 31,
December 31,
2006
2007
2008
2009
2010
2010
(in thousands, except per share data)
$
231
$
10
$
$
$
100
$
3,100
838
910
574
2,322
156
119
39
1
12
3,648
387
129
877
911
686
9,070
429
545
418
1,392
21,205
19,569
18,869
9,766
6,414
176,593
12,598
12,033
15,354
8,538
10,120
81,966
7,934
7,934
225
1,554
489
366
2,634
34,028
33,156
43,075
19,215
16,952
270,519
(33,641
)
(33,027
)
(42,198
)
(18,304
)
(16,266
)
(261,449
)
2,138
6,933
63
(2,214
)
(412
)
5,264
(31,503
)
(26,094
)
(42,135
)
(20,518
)
(16,678
)
(256,185
)
2,245
2,041
1,749
948
657
17,879
(29,258
)
(24,053
)
(40,386
)
(19,570
)
(16,021
)
(238,306
)
(2,827
)
(38,123
)
(3,515
)
(3,515
)
(307
)
(1,227
)
(1,228
)
(167
)
(2,929
)
$
(32,085
)
$
(24,360
)
$
(41,613
)
$
(20,798
)
$
(19,703
)
$
(282,873
)
$
(2.40
)
$
(1.23
)
$
(2.04
)
$
(0.94
)
$
(0.52
)
13,390,933
19,873,911
20,433,129
22,196,840
37,844,695
Table of Contents
As of December 31,
2009
2006
2007
2008
(as restated)
2010
(in thousands)
$
44,238
$
30,987
$
24,220
$
11,493
$
29,495
9,764
27,766
1,502
50,244
49,065
20,387
4,775
24,516
63,276
75,912
30,957
14,466
31,459
(1,436
)
(3,231
)
(1,688
)
53,919
57,969
20,642
5,872
24,924
Table of Contents
Item 7.
Managements Discussion and Analysis of Financial Condition and Results of Operations
(a)
consolidated balance sheets as of March 31, 2009, June 30, 2009, September 30, 2009,
December 31, 2009, March 31, 2010, June 30, 2010, and September 30, 2010 and its statement
of stockholders equity for the year ended December 31, 2009; and
(b)
Selected Financial Data as of and for the year ended December 31, 2009.
(a)
restate our consolidated balance sheet as of December 31, 2009 and statement of
stockholders equity for the year ended December 31, 2009;
(b)
amend our Managements Discussion and Analysis of Financial Condition and Results of
Operations (MD&A) as it relates to the year ended December 31, 2009 and each of the
first, second and third quarters of fiscal 2010;
(c)
restate our Selected Financial Data as of and for the year ended December 31, 2009; and
(d)
restate our unaudited consolidated balance sheets as of March 31, 2009, June 30, 2009,
September 30, 2009, March 31, 2010, June 30, 2010, and September 30, 2010.
Table of Contents
Acute myeloid leukemia, or AML, in the elderly;
Myelodysplastic syndromes, or MDS; and
Non-small cell lung cancer, or NSCLC.
Table of Contents
Table of Contents
Years ended
$ Differences
% Differences
2008 to
2009 to
2008 to
2009 to
2008
2009
2010
2009
2010
2009
2010
(in thousands)
$
$
$
100
$
$
100
%
100
%
838
910
574
72
(336
)
9
%
(37
)%
39
1
12
(38
)
11
(97
)%
1,100
%
$
877
$
911
$
686
$
34
$
(225
)
4
%
(25
)%
Years ended
$ Differences
% Differences
2008 to
2009 to
2008 to
2009 to
2008
2009
2010
2009
2010
2009
2010
(in thousands)
$
429
$
545
$
418
$
116
$
(127
)
27
%
(23
)%
Table of Contents
clinical trial and regulatory-related costs;
payroll and personnel-related expenses, including consultants and contract
research;
preclinical studies and laboratory supplies and materials;
technology license costs; and
rent and facility expenses for our laboratories.
Years ended
$ Differences
% Differences
2008 to
2009 to
2008 to
2009 to
2008
2009
2010
2009
2010
2009
2010
(in thousands)
$
6,601
$
7,001
$
5,222
$
400
$
(1,779
)
6
%
(25
)%
2,906
(84
)
53
(2,990
)
137
(103)
%
163
%
1,695
162
25
(1,533
)
(137
)
(90
)%
(85
)%
7,667
2,687
1,114
(4,980
)
(1,573
)
(65
)%
(59
)%
$
18,869
$
9,766
$
6,414
$
(9,103
)
$
(3,352
)
(48
)%
(34
)%
Table of Contents
Years ended
$ Differences
% Differences
2008 to
2009 to
2008 to
2009 to
2008
2009
2010
2009
2010
2009
2010
(in thousands)
$
15,354
$
8,538
$
10,120
$
(6,816
)
$
1,582
(44
)%
19
%
Table of Contents
Years ended
$ Differences
% Differences
2008 to
2009 to
2008 to
2009 to
2008
2009
2010
2009
2010
2009
2010
(in thousands)
$
7,934
$
$
$
(7,934
)
$
(100
)%
Years ended
$ Differences
% Differences
2008 to
2009 to
2008 to
2009 to
2008
2009
2010
2009
2010
2009
2010
(in thousands)
$
489
$
366
$
$
(123
)
$
(25
)%
%
Table of Contents
Table of Contents
Years ended
$ Differences
% Differences
2008 to
2009 to
2008 to
2009 to
2008
2009
2010
2009
2010
2009
2010
(in thousands)
$
$
(1,652
)
$
$
(1,652
)
$
1,652
(100
)%
100
%
3,502
(299
)
(338
)
(3,801
)
(39
)
(109
)%
(13
)%
(44
)
(44
)
44
(100
)%
100
%
(4,501
)
(144
)
(68
)
4,357
76
97
%
53
%
1,380
102
37
(1,278
)
(65
)
(93
)%
(64
)%
(318
)
(177
)
(43
)
141
134
44
%
76
%
$
63
$
(2,214
)
$
(412
)
$
(2,277
)
$
1,802
(3,614
)%
81
%
Table of Contents
Table of Contents
Years ended
$ Differences
% Differences
2008 to
2009 to
2008 to
2009 to
2008
2009
2010
2009
2010
2009
2010
(in thousands)
$
1,749
$
948
$
657
$
(801
)
$
(291
)
(46
)%
(31
)%
Table of Contents
December 31,
2009
December 31,
(as restated)
2010
$ Difference
% Difference
(in thousands)
$
11,493
$
29,495
$
18,002
157
%
$
13,369
$
31,051
$
17,682
132
%
(8,594
)
(6,535
)
2,059
(24
)%
$
4,775
$
24,516
$
19,741
413
%
The completion of a private placement during October 2010, which resulted in
approximately $14.0 million in net proceeds;
Two registered direct offerings in January 2010 for net proceeds of
approximately $11.9 million; and
The issuance of 2.8 million common shares for approximately $4.9 million as
part of the committed equity financing facility, or CEFF, with Kingsbridge Capital Limited,
or Kingsbridge and the exercise of options and warrants totaling $2.6 million during
2010.
Table of Contents
Year ended December 31,
2008
2009
2010
(in thousands)
$
(29,905
)
$
(14,886
)
$
(16,044
)
$
27,342
$
1,559
$
33
$
(1,238
)
$
3,545
$
33,396
Table of Contents
the rate of progress and cost of our clinical trials, preclinical studies and
other discovery and research and development activities;
the costs associated with establishing manufacturing and commercialization
capabilities;
the costs of acquiring or investing in businesses, product candidates and
technologies;
the costs of filing, prosecuting, defending and enforcing any patent claims and
other intellectual property rights;
the costs and timing of seeking and obtaining FDA and other regulatory
approvals;
the effect of competing technological and market developments; and
the economic and other terms and timing of any collaboration, licensing or
other arrangements into which we may enter.
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Item 7A.
Quantitative and Qualitative Disclosures About Market Risk
Table of Contents
Item 8.
Financial Statements and Supplementary Data
Page
77
78
79
80
88
91
Table of Contents
(A Development Stage Company)
Cyclacel Pharmaceuticals, Inc.
Table of Contents
(A Development Stage Company)
December 31,
2009
(as
restated)
2010
$
11,493
$
29,495
145
174
1,731
1,382
13,369
31,051
901
408
196
$
14,466
$
31,459
$
1,709
$
1,723
5,481
4,132
342
680
1,062
8,594
6,535
8,594
6,535
2
1
26
47
228,109
266,666
20
31
(222,285
)
(241,821
)
5,872
24,924
$
14,466
$
31,459
Table of Contents
(A Development Stage Company)
Period from
August 13,
1996
Year ended
Year ended
Year ended
(inception) to
December 31,
December 31,
December 31,
December 31,
2008
2009
2010
2010
$
$
$
100
$
3,100
838
910
574
2,322
39
1
12
3,648
877
911
686
9,070
429
545
418
1,392
18,869
9,766
6,414
176,593
15,354
8,538
10,120
81,966
7,934
7,934
489
366
2,634
43,075
19,215
16,952
270,519
(42,198
)
(18,304
)
(16,266
)
(261,449
)
(3,550
)
(1,652
)
(1,652
)
(308
)
3,502
(299
)
(338
)
6,070
(44
)
(44
)
(4,501
)
(144
)
(68
)
(4,255
)
1,380
102
37
13,680
(318
)
(177
)
(43
)
(4,677
)
63
(2,214
)
(412
)
5,264
(42,135
)
(20,518
)
(16,678
)
(256,185
)
1,749
948
657
17,879
(40,386
)
(19,570
)
(16,021
)
(238,306
)
(38,123
)
(3,515
)
(3,515
)
(1,227
)
(1,228
)
(167
)
(2,929
)
$
(41,613
)
$
(20,798
)
$
(19,703
)
$
(282,873
)
$
(2.04
)
$
(0.94
)
$
(0.52
)
20,433,129
22,196,840
37,844,695
Table of Contents
(A Development Stage Company)
Deficit
Accumulated
accumulated
Additional
other
during
paid-in
comprehensive
Deferred
development
Preferred Stock
Common Stock
Capital
income/(loss)
compensation
stage
Total
No.
$000
No.
$000
$000
$000
$000
$000
$000
1
1
(4
)
(4
)
(290
)
(290
)
(294
)
1
(4
)
(290
)
(293
)
266,778
4,217
4,217
262
262
2,002
(2,002
)
302
302
55
55
(2,534
)
(2,534
)
(2,479
)
266,778
6,482
51
(1,700
)
(2,824
)
2,009
406
406
11
11
(3,964
)
(3,964
)
(3,953
)
266,778
6,482
62
(1,294
)
(6,788
)
(1,538
)
Table of Contents
(A Development Stage Company)
Deficit
Accumulated
accumulated
Additional
other
during
paid-in
comprehensive
Deferred
development
Preferred Stock
Common Stock
capital
income/(loss)
compensation
stage
Total
No.
$000
No.
$000
$000
$000
$000
$000
$000
538,889
1
12,716
12,717
90,602
1,638
1,638
9,060
164
164
409
409
2,265
40
40
167
(167
)
433
433
(194
)
(194
)
(5,686
)
(5,686
)
(5,880
)
907,594
1
21,616
(132
)
(1,028
)
(12,474
)
7,983
294
(294
)
275
275
(466
)
(466
)
(10,382
)
(10,382
)
(10,848
)
907,594
1
21,910
(598
)
(1,047
)
(22,856
)
(2,590
)
Table of Contents
(A Development Stage Company)
Deficit
Accumulated
accumulated
Additional
other
during
paid-in
comprehensive
Deferred
development
Preferred Stock
Common Stock
capital
income/(loss)
compensation
stage
Total
No.
$000
No.
$000
$000
$000
$000
$000
$000
5,451
106
106
4,510
183
183
1,215
1,215
363
(363
)
672
672
191
191
(14,853
)
(14,853
)
(14,662
)
917,555
1
23,777
(407
)
(738
)
(37,709
)
(15,076
)
12
12
(84
)
84
305
305
(1,846
)
(1,846
)
(15,542
)
(15,542
)
(17,388
)
917,555
1
23,705
(2,253
)
(349
)
(53,251
)
(32,147
)
Table of Contents
(A Development Stage Company)
Deficit
Accumulated
accumulated
Additional
other
during
paid-in
comprehensive
Deferred
development
Preferred Stock
Common Stock
capital
income/(loss)
compensation
stage
Total
No.
$000
No.
$000
$000
$000
$000
$000
$000
1,510,288
1
27,634
27,635
6,549
115
115
3,769,139
4
58,144
58,148
217
217
(1,343
)
(1,343
)
(14,977
)
(14,977
)
(16,320
)
6,203,531
6
109,598
(3,596
)
(132
)
(68,228
)
37,648
430,571
1
8,540
8,541
22,630
(2,050
)
132
(1,918
)
2,424
2,424
(22,742
)
(22,742
)
(20,318
)
6,656,732
7
116,088
(1,172
)
(90,970
)
23,953
(1,786
)
(1,786
)
(18,048
)
(18,048
)
(19,834
)
6,656,732
7
116,088
(2,958
)
(109,018
)
4,119
Table of Contents
(A Development Stage Company)
Deficit
Accumulated
accumulated
Additional
other
during
paid-in
comprehensive
Deferred
development
Preferred Stock
Common Stock
capital
income/(loss)
compensation
stage
Total
No.
$000
No.
$000
$000
$000
$000
$000
$000
648,413
1
(1
)
456,308
2,046,813
2
1,967,928
2
16,251
16,255
10,420
10,420
6,428,572
6
42,356
42,362
9,600
9,600
5
5
416
416
(29,258
)
(29,258
)
(28,842
)
2,046,813
2
16,157,953
16
194,714
(2,537
)
(138,276
)
53,919
Table of Contents
(A Development Stage Company)
Deficit
Accumulated
accumulated
Additional
other
during
paid-in
comprehensive
Deferred
development
Preferred Stock
Common Stock
capital
income/(loss)
compensation
stage
Total
No.
$000
No.
$000
$000
$000
$000
$000
$000
1,733
1,733
25,508
163
163
4,249,668
4
33,353
33,357
(307
)
(307
)
(6,750
)
(6,750
)
(93
)
(93
)
(24,053
)
(24,053
)
(24,146
)
2,046,813
2
20,433,129
20
222,906
(2,630
)
(162,329
)
57,969
1,698
1,698
(1,227
)
(1,227
)
(12,330
)
(12,330
)
14,918
14,918
(40,386
)
(40,386
)
(37,798
)
2,046,813
2
20,433,129
20
223,377
(42
)
(202,715
)
20,642
Table of Contents
(A Development Stage Company)
Deficit
Additional
Accumulated
accumulated
paid-in
other
during
Capital
comprehensive
Deferred
development
Total
Preferred Stock
Common Stock
(as restated)
income/(loss)
compensation
stage
(as restated)
No.
$000
No.
$000
$000
$000
$000
$000
$000
44
44
4,000,000
4
2,843
2,847
1,255,024
2
1,028
1,030
55,210
7
7
810
810
5,651
5,651
(5,589
)
(5,589
)
(19,570
)
(19,570
)
(19,508
)
2,046,813
2
25,743,363
26
228,109
20
(222,285
)
5,872
Table of Contents
(A Development Stage Company)
Deficit
Accumulated
accumulated
Additional
other
during
paid-in
comprehensive
Deferred
development
Preferred Stock
Common Stock
capital
income/(loss)
compensation
stage
Total
No.
$000
No.
$000
$000
$000
$000
$000
$000
5,200,000
5
11,892
11,897
2,818,925
3
4,860
4,863
2,618,266
3
2,496
2,499
8,323,190
8
13,972
13,980
205,571
77
77
(833,671
)
(1
)
1,655,599
2
3,514
(3,515
)
1,746
1,746
(2,073
)
(2,073
)
2,084
2,084
(16,021
)
(16,021
)
(16,010
)
1,213,142
1
46,564,914
47
266,666
31
(241,821
)
24,924
Table of Contents
(A Development Stage Company)
Period from
August 13, 1996
(inception)
Year ended
Year ended
Year ended
to
December 31,
December 31,
December 31,
December 31,
2008
2009
2010
2010
$000
$000
$000
$000
(40,386
)
(19,570
)
(16,021
)
(238,306
)
(10
)
79
2
100
(1,444
)
20
(2,297
)
308
(3,502
)
299
338
(6,070
)
44
44
1,154
668
457
12,314
708
886
221
221
4,831
7,747
(98
)
1,215
446
2
83
(13
)
99
7,934
7,934
1,698
810
1,746
18,141
1,779
2,517
1,732
1,716
516
(232
)
(2,701
)
821
(3,067
)
(5,890
)
(29,905
)
(14,886
)
(16,044
)
(199,142
)
Table of Contents
(A Development Stage Company)
Period from
August 13, 1996
(inception)
Year ended
Year ended
Year ended
to
December 31,
December 31,
December 31,
December 31,
2008
2009
2010
2010
$000
$000
$000
$000
(3,763
)
(366
)
(15
)
(8
)
(8,831
)
91
41
158
(3,057
)
(156,657
)
30,765
1,483
162,729
27,342
1,559
33
(6,364
)
(11
)
(3,719
)
30,820
121,678
3,845
2,576
82,404
7
170
(1,227
)
(307
)
(1,534
)
(455
)
414
9,103
8,883
1,645
17,915
(1,951
)
(1,238
)
3,545
33,396
234,553
(2,966
)
(2,945
)
617
448
(6,767
)
(12,727
)
18,002
29,495
30,987
24,220
11,493
24,220
11,493
29,495
29,495
Table of Contents
Period from
August 13, 1996
(inception)
Year ended
Year ended
Year ended
to
December 31,
December 31,
December 31,
December 31,
2008
2009
2010
2010
$000
$000
$000
$000
723
59
11
11,715
2,033
1,523
1,082
17,522
(78
)
(155
)
(1,914
)
80
80
3,470
592
1,638
8,893
164
1,122
Table of Contents
(A Development Stage Company)
Acute myeloid leukemia, or AML in the elderly;
Myelodysplastic syndromes, or MDS; and
Non-small cell lung cancer or NSCLC.
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Year ended
Year ended
Year ended
December 31,
December 31,
December 31,
2008
2009
2010
3,674,899
3,349,876
3,489,932
141,700
91,145
59,885
870,980
870,980
516,228
328,602
6,242,398
3,809,272
7,044,363
10,005,192
8,496,851
11,684,966
20,313,635
Table of Contents
Table of Contents
Table of Contents
(A Development Stage Company)
As Previously
Reported on
Form 10-K/A
Adjustments
As Restated
$
11,493
$
$
11,493
145
145
1,731
1,731
13,369
13,369
901
901
196
196
$
14,466
$
$
14,466
$
1,709
$
$
1,709
6,709
(1,228
)
5,481
342
342
1,062
1,062
9,822
(1,228
)
8,594
9,822
(1,228
)
8,594
2
2
26
26
226,881
1,228
228,109
20
20
(222,285
)
(222,285
)
4,644
1,228
5,872
$
14,466
$
$
14,466
Table of Contents
Table of Contents
December 31,
2009
2010
$000
$000
2,996
429
8,497
29,066
11,493
29,495
Fair Value Measurements
Using Fair Value Hierarchy
Level 1
Level 2
Level 3
$000
$000
$000
680
Table of Contents
December 31,
2009
2010
$
8.44
$
8.44
4.13 Yrs
3.13 Yrs
2.13
%
1.02
%
96
%
121
%
Level 3
$000
342
338
680
December 31,
2009
2010
$000
$000
1,096
660
456
317
179
405
1,731
1,382
Table of Contents
Useful lives in years from
December 31,
date of acquisition
2009
2010
$000
$000
5 to 15 yrs
860
844
3 to 5 yrs
7,673
6,281
3 to 5 yrs
1,280
1,267
9,813
8,392
(8,912
)
(7,984
)
901
408
December 31,
2009
(as restated)
2010
$000
$000
2,654
2,793
283
26
136
112
651
796
961
1,201
5,481
4,132
(1)
(2)
Table of Contents
Operating
lease
obligations
$000
557
545
405
405
400
4,270
6,582
Table of Contents
Table of Contents
Table of Contents
$
10.24
$
10.18
$
10.12
$
10.06
$
10.00
Year ended
December 31, 2010
833,671
354,752
1,300,847
1,655,599
Table of Contents
Table of Contents
Table of Contents
Table of Contents
Weighted
Average
Expiration
Common Shares
Exercise
Issued in Connection With
Date
Issuable
Price
2013
2,571,429
$
7.00
2014
1,062,412
$
8.44
2013
100,000
$
1.40
2014
692,256
$
1.00
2015
712,500
$
3.26
2015
705,000
$
2.85
2015
4,161,595
$
1.92
10,005,192
$
4.01
Year ended
Year ended
Year ended
December 31,
December 31,
December 31,
2008
2009
2010
$000
$000
$000
736
271
351
962
539
1,395
1,698
810
1,746
Table of Contents
Table of Contents
Weighted
Weighted
average
Number of
average
remaining
Aggregate
options
exercise
contractual
intrinsic
Cyclacel Pharmaceuticals, Inc.
outstanding
price
term (years)
value
3,674,899
$
4.36
8.74
$
2
221,000
$
0.39
(17,180
)
$
0.43
(528,843
)
$
3.76
3,349,876
$
4.21
7.76
$
698
607,300
$
1.82
(174,311
)
$
0.43
(292,933
)
$
4.54
3,489,932
$
3.96
7.22
$
938
1,151,947
$
2.02
8.68
$
344
2,337,985
$
4.92
6.50
$
594
Weighted
Average
Number
remaining
Number
Exercise price ($)
outstanding
contractual life
exercisable
1,341,890
8.54
584,162
394,000
8.13
138,677
524,033
6.83
397,953
1,208,009
5.68
1,195,193
22,000
4.11
22,000
3,489,932
2,337,985
Year ended
Year ended
Year ended
December 31,
December 31,
December 31,
2008
2009
2010
4.25 6 Yrs
0.75 5 Yrs
5 6 Yrs
1.54 3.76%
0.325 .84%
1.64 2.96%
45 75%
65 169%
90 102%
0.00%
0.00%
0.00%
$0.68
$0.39
$1.40
Table of Contents
Table of Contents
Weighted Average Grant
Restricted Stock Units
Date Value Per Share
36,458
$
0.44
(12,504
)
$
0.44
23,954
$
0.44
Weighted Average Grant
Restricted Stock Units
Date Value Per Share
54,687
$
0.44
(18,756
)
$
0.44
35,931
$
0.44
Table of Contents
Lease
restructuring
Sales tax
charges
assessment
Total
$000
$000
$000
2,091
270
2,361
(1,156
)
(372
)
(1,528
)
127
127
102
102
1,062
1,062
(1,104
)
(1,104
)
42
42
Table of Contents
Year ended
Year ended
Year ended
December 31,
December 31,
December 31,
2008
2009
2010
$000
$000
$000
(11,337
)
(3,013
)
(4,664
)
(30,798
)
(17,505
)
(12,014
)
(42,135
)
(20,518
)
(16,678
)
Year ended
Year ended
Year ended
December 31,
December 31,
December 31,
2008
2009
2010
$000
$000
$000
(4
)
(12
)
(10
)
1,753
960
667
1,749
948
657
Table of Contents
Year ended
Year ended
Year ended
December 31,
December 31,
December 31,
2008
2009
2010
$000
$000
$000
(42,135
)
(20,518
)
(16,678
)
(14,361
)
(6,976
)
(5,672
)
3
8
7
(1,939
)
(773
)
(490
)
3,584
2,322
1,605
(2,191
)
(1,185
)
(793
)
11,161
4,605
3,984
438
237
132
1,556
814
570
(1,749
)
(948
)
(657
)
December 31,
2009
2010
$000
$000
42,534
43,056
1,996
1,925
399
775
1,228
2,684
3,778
67
89
(3,097
)
(2,452
)
45,358
47,624
(45,358
)
(47,624
)
Table of Contents
December 31,
2009
2010
$000
$000
127,633
132,521
Table of Contents
Year ended
Year ended
Year ended
December 31,
December 31,
December 31,
2008
2009
2010
$000
$000
$000
838
910
574
39
1
112
877
911
686
(11,341
)
(3,007
)
(4,662
)
(29,045
)
(16,563
)
(11,359
)
(40,386
)
(19,570
)
(16,021
)
December 31,
2008
2009
2010
$000
$000
$000
22,842
10,460
30,055
8,115
4,006
1,404
30,957
14,466
31,459
516
330
161
1,232
571
247
1,748
901
408
Table of Contents
For the three months ended
March 31,
June 30,
September 30,
December 31,
2010
2010
2010
2010
$000, except per share amounts
271
119
159
137
(5,244
)
(4,163
)
(3,950
)
(3,321
)
(5,819
)
(6,543
)
(3,989
)
(3,352
)
$
(0.18
)
$
(0.18
)
$
(0.11
)
$
(0.07
)
For the three months ended
March 31,
June 30,
September 30,
December 31,
2009
2009
2009
2009
$000, except per share amounts
228
266
230
187
(5,421
)
(7,278
)
(3,329
)
(4,490
)
(5,370
)
(7,352
)
(3,431
)
(4,645
)
$
(0.26
)
$
(0.36
)
$
(0.15
)
$
(0.19
)
(1)
Table of Contents
(A Development Stage Company)
As Previously
Reported on
Form 10-Q
Adjustments
As Restated
$
18,482
$
$
18,482
144
144
1,057
1,057
19,683
19,683
512
512
196
196
$
20,391
$
$
20,391
$
1,340
$
$
1,340
5,641
(1,213
)
4,428
785
785
199
199
7,965
(1,213
)
6,752
7,965
(1,213
)
6,752
2
2
37
37
250,466
1,813
252,279
(30
)
(30
)
(238,049
)
(600
)
(238,649
)
12,426
1,213
13,639
$
20,391
$
$
20,391
Table of Contents
(A Development Stage Company)
As Previously
Reported on
Form 10-Q
Adjustments
As Restated
$
19,543
$
$
19,543
39
39
1,925
1,925
21,507
21,507
606
606
196
196
$
22,309
$
$
22,309
$
1,550
$
$
1,550
5,255
(1,032
)
4,223
858
858
492
492
8,155
(1,032
)
7,123
8,155
(1,032
)
7,123
1
1
37
37
248,314
1,632
249,946
42
42
(234,240
)
(600
)
(234,840
)
14,154
1,032
15,186
$
22,309
$
$
22,309
Table of Contents
(A Development Stage Company)
As Previously
Reported on
Form 10-Q
Adjustments
As Restated
$
24,200
$
$
24,200
107
107
1,558
1,558
25,865
25,865
715
715
196
196
$
26,776
$
$
26,776
$
1,782
$
$
1,782
5,818
(1,443
)
4,375
1,131
1,131
780
780
9,511
(1,443
)
8,068
9,511
(1,443
)
8,068
2
2
35
35
244,991
1,528
246,519
52
52
(227,815
)
(85
)
(227,900
)
17,265
1,443
18,708
$
26,776
$
$
26,776
Table of Contents
(A Development Stage Company)
CONSOLIDATED BALANCE SHEET (Unaudited)
(In $000s, except share amounts)
Table of Contents
(A Development Stage Company)
CONSOLIDATED BALANCE SHEET (Unaudited)
(In $000s, except share amounts)
Table of Contents
(A Development Stage Company)
CONSOLIDATED BALANCE SHEET
Table of Contents
Item 9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Table of Contents
Table of Contents
Table of Contents
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
Item 10.
Directors, Executive Officers and Corporate Governance
Name
Age
Position
52
President and Chief Executive Officer; Director
50
Executive Vice President Finance, Chief Financial Officer, Chief Operating Officer and Secretary; Director
51
Vice President, Clinical Development and Regulatory Affairs
52
Vice President, Sales & Marketing
62
Director
70
Director
69
Vice Chairman of the Board of Directors
52
Director
62
Chairman of the Board of Directors; Common Stock Nominee for Class 2 Director
39
Preferred Stock Director Nominee
50
Preferred Stock Director Nominee
Table of Contents
Table of Contents
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Table of Contents
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Table of Contents
Item 11.
Executive Compensation
All
Stock
Option
Other
Salary
Bonus
Awards
Awards
Compensation
Total
Name and Principal Position
Year
($)
($)(1)
($)
(2)
($)
(3)
($)
(4)
($)
President and
2010
476,100
59,500
92,250
32,506
660,356
2009
460,000
138,000
(4)
32,188
630,188
Executive Vice President,
Finance, Chief Operating Officer,
2010
289,768
36,350
92,250
17,732
436,100
2009
288,297
86,489
(4)
17,903
392,689
MD
Vice President, Clinical
2010
312,570
75,000
76,875
19,624
484,069
2009
302,000
72,480
(4)
20,552
395,032
(1)
Bonuses earned in 2009 were paid during fiscal year 2010 and were not accrued in the
Companys Financial Statements. Bonuses earned in 2010 were paid during fiscal year 2010 and
were not accrued in the Companys Financial Statements.
(2)
This column represents the dollar amount recognized for financial statement reporting
purposes for the fair value of stock awards. The fair value, a non-cash expense, was estimated
using the Black-Scholes option-pricing method in accordance with ASC Topic 718. See Note 13 to
our Financial Statements reported in our Form 10-K/A for our fiscal year ended December 31,
2009 and Note 11 to our Financial Statements reported in our Form 10-K for our fiscal year
ended December 31, 2010 for details as to the assumptions used to determine the fair value of
the stock awards and stock options. See also our discussion of stock-based compensation under
Managements Discussion and Analysis of Financial Condition and Results of
OperationsCritical Accounting Policies and Estimates.
(3)
These amounts represent the aggregate grant date fair value for option awards for fiscal
years 2009 and 2010, respectively, computed in accordance with FASB ASC Topic 718. The grant
date fair value of performance awards is determined based on the probable outcome of such
performance conditions as of the grant date. A discussion of the assumptions used in
determining grant date fair value may be found in Note 11 to our Financial Statements,
included in our Annual Report on Form 10-K for the year ended December 31, 2010.
Table of Contents
4)
Consists of the following for all executive officers: Payments for private medical and health
insurance, life insurance and permanent health insurance; matching contributions made under
the Companys UK Group Personal Pension Plan and the U.S. 401(k) Plan.
5)
Mr. McBarrons compensation was translated from British pound sterling to the U.S. dollar
using the exchange rate of $1.59280 as of December 31, 2009 and $1.54679 as of December 31,
2010.
the executives scope of responsibilities;
an informed market assessment of competitive practices for similar
roles within peer group companies;
evaluations of performance for the year, as assessed by the Chief
Executive Officer, supported by the Companys performance review process and the
executives self assessment; and
recommendations by our Chief Executive Officer for each named executive
officer with respect to base salary, cash bonus, and stock-based compensation.
Table of Contents
Option Awards
Stock Awards
Number of
Number of
Securities
Securities
Number of
Underlying
Underlying
Shares or
Market Value of
Unexercised
Unexercised
Option
Units of Stock
Shares or Units of
Options
Options
Exercise
Option
That Have Not
Stock That Have
#
#
Price
Expiration
Vested
Not Vested
(1)
Name
Exercisable
Unexercisable
($)
Date
#
$
97,834
0
$
6.40
06/13/2016
160,000
0
(2)
$
6.95
12/20/2016
150,000
50,000
(3)
$
5.53
12/06/2017
29,171
45,829
(4)
$
0.44
11/18/2018
0
75,000
(5)
$
1.59
12/10/2020
23,954
(6)
35,212
Table of Contents
Option Awards
Stock Awards
Number of
Number of
Securities
Securities
Number of
Underlying
Underlying
Shares or
Market Value of
Unexercised
Unexercised
Option
Units of Stock
Shares or Units of
Options
Options
Exercise
Option
That Have Not
Stock That Have
#
#
Price
Expiration
Vested
Not Vested
(1)
Name
Exercisable
Unexercisable
($)
Date
#
$
63,680
0
$
6.40
06/13/2016
100,000
0
(7)
$
6.95
12/20/2016
75,000
25,000
(8)
$
5.53
12/06/2017
104,171
45,829
(9)
$
0.44
11/18/2018
0
75,000
(10)
$
1.59
12/10/2020
23,954
(11)
35,212
48,967
0
$
6.40
06/13/2016
80,000
0
(12)
$
6.95
12/20/2016
75,000
25,000
(13)
$
5.53
12/06/2017
52,085
22,915
(14)
$
0.44
11/18/2018
0
62,500
(15)
$
1.59
12/10/2020
11,977
(16)
17,606
(1)
The market value of the shares is determined by multiplying the number of shares by $1.47,
the closing price of our common stock on the NASDAQ Global Market on December 31, 2010, the
last day of our fiscal year.
(2)
These options were granted on December 21, 2006, and are exercisable over a four-year period
with one-fourth (1/4) of the options granted vesting on December 21, 2007, the first
anniversary of the grant date, and the balance of the options granted vesting ratably on a
monthly basis over the following 36 months.
(3)
These options were granted on December 6, 2007, and are exercisable over a four-year period
with one-fourth (1/4) of the options granted vesting on December 6, 2008, the first
anniversary of the grant date, and the balance of the options granted vesting ratably on a
monthly basis over the following 36 months.
(4)
These options were granted on November 18, 2008, and vest over a three-year period, with
one-third (1/3) of the options granted vesting on November 18, 2009, the first anniversary of
the grant date, and the balance of the options granted vesting ratably on a monthly basis over
the following 24 months.
(5)
These options were granted on December 10, 2010, and vest over a four-year period, such
options vesting ratably on a monthly basis over 48 months.
(6)
The restricted stock units were granted on November 18, 2008, and vest over a four-year
period, with one-fourth (1/4) of the restricted stock units granted vesting on November 18,
2009, the first anniversary of the grant date, and the balance of the restricted stock units
granted vesting ratably on a monthly basis over the following 36 months.
(7)
These options were granted on December 21, 2006, and are exercisable over a four-year period
with one-fourth (1/4) of the options granted vesting on December 21, 2007, the first
anniversary of the grant date, and the balance of the options granted vesting ratably on a
monthly basis over the following 36 months.
(8)
These options were granted on December 6, 2007, and are exercisable over a four-year period
with one-fourth (1/4) of the options granted vesting on December 6, 2008, the first
anniversary of the grant date, and the balance of the options granted vesting ratably on a
monthly basis over the following 36 months.
Table of Contents
(9)
These options were granted on November 18, 2008, and vest over a three-year period, with
one-third (1/3) of the options granted vesting on November 18, 2009, the first anniversary of
the grant date, and the balance of the options granted vesting ratably on a monthly basis over
the following 24 months.
(10)
These options were granted on December 10, 2010, and vest over a four-year period, such
options vesting ratably on a monthly basis over 48 months.
(11)
These shares of common stock represent restricted stock and are subject to forfeiture; the
restrictions shall lapse over a four-year period, as follows: the restrictions with respect to
one-fourth (1/4) of the restricted stock granted shall lapse on November 18, 2009, the first
anniversary of the grant date, and the restrictions with respect to the balance of the
restricted stock granted shall lapse ratably on a monthly basis over the following 36 months.
(12)
These options were granted on December 21, 2006, and are exercisable over a four-year period
with one-fourth (1/4) of the options granted vesting on December 21, 2007, the first
anniversary of the grant date, and the balance of the options granted vesting ratably on a
monthly basis over the following 36 months.
(13)
These options were granted on December 6, 2007, and are exercisable over a four-year period
with one-fourth (1/4) of the options granted vesting on December 6, 2008, the first
anniversary of the grant date, and the balance of the options granted vesting ratably on a
monthly basis over the following 36 months.
(14)
These options were granted on November 18, 2008, and vest over a three-year period, with
one-third (1/3) of the options granted vesting on November 18, 2009, the first anniversary of
the grant date, and the balance of the options granted vesting ratably on a monthly basis over
the following 24 months.
(15)
These options were granted on December 10, 2010, and vest over a four-year period, such
options vesting ratably on a monthly basis over 48 months.
(16)
The restricted stock units were granted on November 18, 2008, and vest over a four-year
period, with one-fourth (1/4) of the restricted stock units granted vesting on November 18,
2009, the first anniversary of the grant date, and the balance of the restricted stock units
granted vesting ratably on a monthly basis over the following 36 months.
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assumed by the successor corporation or a parent or subsidiary of the
successor corporation; or
substituted with an equivalent award by the successor corporation or a
parent or subsidiary of the successor corporation.
awards consisting of options, SARs and rights to purchase restricted
stock will become fully vested and immediately exercisable, including awards that
would not otherwise have become vested or exercisable; and
all other awards will become fully earned and eligible to receive a
payout.
a person, partnership, joint venture, corporation or other entity, or
two or more of any of the foregoing acting as a group (or any person within the
meaning of Sections 13(d)(3) and 14(d) of the 1934 Act), other than the Company, a
Subsidiary, or an employee benefit plan (or related trust) of the Company or a
Subsidiary, become(s) the beneficial owner (as defined in Rule 13d-3 under the
1934 Act) of 30% or more of the then-outstanding voting stock of the Company;
during any period of two consecutive years, individuals who at the
beginning of such period constitute the Board of Directors (together with any new
director whose election by the Board of Directors or whose nomination for election
by the Companys stockholders, was approved by a vote of at least two-thirds of the
directors then still in office who either were directors at the beginning of such
period or whose election or nomination for election
was previously so approved) cease for any reason to constitute a majority of the
directors then in office;
Table of Contents
all or substantially all of the business of the Company is disposed of
pursuant to a merger, consolidation or other transaction in which the Company is
not the surviving corporation or the Company combines with another Company and is
the surviving corporation (unless the stockholders of the Company immediately
following such merger, consolidation, combination, or other transaction
beneficially own, directly or indirectly, more than 50% of the aggregate voting
stock or other ownership interests of (x) the entity or entities, if any, that
succeed to the business of the Company or (y) the combined company);
the Company is a party to a merger, consolidation, sale of assets or
other reorganization, or a proxy contest, as a consequence of which the Board of
Directors in office immediately prior to such transaction or event constitutes less
than a majority of the Board of Directors thereafter; or
the stockholders of the Company approve a sale of all or substantially
all of the assets of the Company or a liquidation or dissolution of the Company.
Fees Earned or
Option
Paid in Cash
Awards
Total
Name
($)
($)
(1)
($)
66,000
89,500
(2)
155,500
37,000
44,750
(3)
81,750
29,000
44,750
(4)
73,750
56,000
89,500
(5)
145,500
43,000
62,650
(6)
105,650
(1)
These amounts represent the grant date fair value of stock awards granted to each director
in 2010 computed in accordance with FASB ASC Topic 718. The grant date fair value of
performance awards is determined based on the probable outcome of such performance conditions
as of the grant date. A discussion of the assumptions used in determining grant date fair
value may be found in Note 11 to our Financial Statements, included in our Annual Report on
Form 10-K for the year ended 2010, as amended
.
(2)
Fair value of the options granted on March 29, 2010 was $1.79 per share. 250,000 options
remain outstanding as of December 31, 2010.
(3)
Fair value of the options granted on March 29, 2010 was $1.79 per share. 125,000 options
remain outstanding as of December 31, 2010.
(4)
Fair value of the options granted on March 29, 2010 was $1.79 per share. 75,000 options
remain outstanding as of December 31, 2010.
(5)
Fair value of the options granted on March 29, 2010 was $1.79 per share. 271,000 options
remain outstanding as of December 31, 2010.
(6)
Fair value of the options granted on March 29, 2010 was $1.79 per share. 156,500 options
remain outstanding as of December 31, 2010.
Table of Contents
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholders Matters
Table of Contents
Number of
Shares
of Common
Percentage of
Stock
Common
Beneficially
Stock
Owned
(1)
Owned
40,703
*
131,299
*
355,524
*
217,071
*
556,930
1.19
%
1,042,562
2.21
%
115,605
*
214,210
*
2,673,904
5.53
%
New York, NY 10022
9,911,148
18.91
%
*
Represents beneficial ownership of less than 1% of the outstanding shares of our common
stock.
(1)
Beneficial ownership is determined in accordance with the rules of the SEC and generally
includes voting or investment power with respect to securities. Beneficial ownership also includes
shares of common stock subject to options, warrants and preferred stock currently exercisable or
convertible, or exercisable or convertible within 60 days of March 22, 2011. Except as indicated by
footnote, to our knowledge, all persons named in the table above have sole voting and investment
power with respect to all shares of common stock shown as beneficially owned.
(2)
Includes options to purchase 38,203 shares of Common Stock that are exercisable within 60
days of March 22, 2011.
(3)
Includes options to purchase 94,452 shares of Common Stock that are exercisable within 60
days of March 22, 2011.
(4)
Includes options to purchase 282,356 shares of Common Stock that are exercisable within 60
days of March 22, 2011. Also includes 10,414 restricted stock units.
(5)
Includes options to purchase 209,904 shares of Common Stock that are exercisable within 60
days of March 22, 2011.
(6)
Includes options to purchase 380,876 shares of Common Stock that are exercisable within 60
days of March 22, 2011.
(7)
Includes options to purchase 484,404 shares of Common Stock that are exercisable within 60
days of March 22, 2011. Also includes 20,828 restricted stock units. Of the shares of Common Stock
reported, 1,000 shares are held indirectly by Mr. Rombotis through his IRA account.
Table of Contents
(8)
Includes options to purchase 115,605 shares of Common Stock that are exercisable within 60
days of March 22, 2011.
(9)
Includes options to purchase 188,904 shares of Common Stock that are exercisable within 60
days of March 22, 2011.
(10)
See footnotes (2)-(9). Also includes options to purchase 108,781 shares of Common Stock
held by Robert Sosnowski, our Vice President, Sales & Marketing, which are exercisable within 60
days of March 22, 2011.
(11)
Based on a Schedule 13G filed on February 11, 2011 with the SEC by Austin W. Marxe
(Marxe) and David M. Greenhouse (Greenhouse). Marxe and Greenhouse share sole voting and
investment power over 4,106,900 shares of common stock, 2,724,073 warrants to purchase shares of
common stock, 176,200 warrants (not currently exercisable) and options to purchase 2,053,450 units
(each unit consists of one share of common stock and warrant to purchase 0.5 of common stock). This
amount includes 547,600 shares of common stock, 381,965 warrants to purchase shares of common
stock, 26,400 warrants (not currently exercisable) and options to purchase 273,800 units (each unit
consists of one share of common stock and warrant to purchase 0.5 of common stock) owned by Special
Situations Private Equity Fund, L.P., 684,500 shares of common stock, warrants to purchase 342,250
shares of common stock and options to purchase 342,250 units (each unit consists of one share of
common stock and warrant to purchase 0.5 of common stock) are owned by Special Cayman Fund, L.P.,
2,053,400 shares of common stock, 1,459,360 warrants to purchase shares of common stock, 114,000
warrants (not currently exercisable) and options to purchase 1,026,700 units (each unit consists of
one share of common stock and warrant to purchase 0.5 of common stock) owned by Special Situations
Fund III QP, L.P. and 821,400 shares of common stock, 540,498 warrants to purchase shares of common
stock, 35,800 warrants (not currently exercisable) and options to purchase 410,700 units (each unit
consists of one share of common stock and warrant to purchase 0.5 of common stock) owned by Special
Situations Life Sciences Fund, L.P. Marxe and Greenhouse are the controlling principals of AWM
Investment Company, Inc., the general partner of and investment adviser to Special Situations
Cayman Fund, L.P. AWM also serves as the general partner of MGP Advisers Limited Partnership, the
general partner of Special Situations Fund III QP, L.P. Marxe and Greenhouse are members of MG
Advisers L.L.C., the general partner of Special Situations Private Equity Fund, L.P. Marxe and
Greenhouse are also members of LS Advisers L.L.C., the general partner of Special Situations Life
Sciences Fund, L.P. AMW serves as the investment adviser to Special Situations Private Equity Fund,
L.P., Special Situations Fund III QP, L.P. and Special Situations Life Sciences Fund, L.P.
(a)
(b)
(c)
Number of
securities remaining
available for future
Weighted-average
issuance under
No. of securities to
exercise price
equity compensation
be issued upon exercise
of outstanding
plans (excluding
of outstanding options,
options, warrants
securities reflected in
Plan Category
warrants and rights
and rights
column (a))
holders (1)
3,549,817
$
3.90
1,363,894
(1)
Consists of our Amended and Restated 2006 Stock Option Plan (the 2006 Plan). The 2006
Plan provides for the grant of incentive stock options, nonqualified stock options, stock
appreciation rights, restricted stock, restricted stock units and performance units. The number of
shares available for issuance, as of March 18, 2011, under the 2006 Plan is 5,200,000.
Table of Contents
Item 13.
Certain Relationships and Related Transactions, and Director Independence
Item 14.
Principal Accountant Fees and Services
2009
2010
$
417,237
$
500,272
71,127
31,850
$
488,364
$
532,122
(1)
Audit fees represent fees of E&Y for the audit of the Companys annual
consolidated financial statements; reviews of the Companys quarterly results of operations and
reports on Form 10-Q; the audit of managements assessment of the effectiveness of the Companys
internal control over financial reporting and the audit of internal control over financial
reporting; and the services that an independent auditor would customarily provide in connection
with subsidiary audits, other regulatory filings, and similar engagements for each fiscal year
shown, such as attest services, consents, and assistance with review of documents filed with the
SEC.
(2)
Tax fees represent tax compliance and return preparation and tax planning and
advice.
Table of Contents
Table of Contents
152
153
154
155
Item 15.
Exhibits and Financial Statement Schedules
(a)
Documents filed as part of this report are as follows:
(1)
Financial Statements and Report of Independent Registered Public Accounting Firm
(2)
Financial Statement Schedules
None required.
(3)
Exhibits: see below Item 15(b)
(b)
Exhibits:
EXHIBIT
NUMBER
DESCRIPTION
1.1
1.2
1.3
3.1
3.1.1
3.2
3.3
4.1
Table of Contents
EXHIBIT
NUMBER
DESCRIPTION
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
10.1
10.2
10.3
Table of Contents
EXHIBIT
NUMBER
DESCRIPTION
10.4
10.5
10.6
10.7
10.8
10.9
10.10
10.11
10.12
10.13
10.14
10.15
Table of Contents
EXHIBIT
NUMBER
DESCRIPTION
10.16
10.17
10.18
10.19
10.20
10.21
10.22
10.23
21
*
23.1
*
31.1
*
31.2
*
32.1
**
32.2
**
Indicates management compensatory plan, contract or arrangement.
*
Filed herewith.
**
Furnished herewith.
Table of Contents
CYCLACEL PHARMACEUTICALS, INC.
By:
/s/ Paul McBarron
Chief Operating Officer &
Executive Vice President, Finance
Signature
Title
Date
President & Chief Executive Officer
March 31, 2011
(Principal
Executive Officer)
and Director
Chief Operating Officer &
March 31, 2011
Executive
Vice President, Finance
(Principal Financial and Accounting Officer)
and Director
Chairman
March 31, 2011
Vice Chairman
March 31, 2011
Director
March 31, 2011
Director
March 31, 2011
Director
March 31, 2011
ARTICLE I. CORPORATE OFFICES
|
1 | |||
1.1. Registered Office
|
1 | |||
1.2. Other Offices
|
1 | |||
ARTICLE II. MEETINGS OF STOCKHOLDERS
|
1 | |||
2.1. Place of Meetings
|
1 | |||
2.2. Annual Meeting
|
1 | |||
2.3. Special Meeting
|
2 | |||
2.4. Notice of Stockholders Meetings; Affidavit of Notice
|
2 | |||
2.5. Advance Notice of Stockholder Nominees and Other Stockholder Proposals
|
3 | |||
2.6. Quorum
|
4 | |||
2.7. Adjourned Meeting; Notice
|
4 | |||
2.8. Organization; Conduct of Business
|
4 | |||
2.9. Voting
|
5 | |||
2.10. Waiver of Notice
|
5 | |||
2.11. Record Date for Stockholder Notice; Voting
|
5 | |||
2.12. Proxies
|
6 | |||
ARTICLE III. DIRECTORS
|
6 | |||
3.1. Powers
|
6 | |||
3.2. Number of Directors
|
6 | |||
3.3. Election, Qualification and Term of Office of Directors
|
7 | |||
3.4. Resignation and Vacancies
|
7 | |||
3.5. Place of Meetings; Meetings by Telephone
|
8 | |||
3.6. Regular Meetings
|
8 | |||
3.7. Special Meetings; Notice
|
8 | |||
3.8. Quorum
|
9 | |||
3.9. Waiver of Notice
|
9 | |||
3.10. Board Action by Written Consent Without a Meeting
|
9 | |||
3.11. Fees and Compensation of Directors
|
10 | |||
3.12. Approval of Loans to Officers
|
10 | |||
3.13. Removal of Directors
|
10 | |||
3.14. Chairman of the Board of Directors
|
11 |
i
ARTICLE IV. COMMITTEES
|
11 | |||
4.1. Committees of Directors
|
11 | |||
4.2. Committee Minutes
|
11 | |||
4.3. Meetings and Action of Committees
|
12 | |||
ARTICLE V. OFFICERS
|
12 | |||
5.1. Officers
|
12 | |||
5.2. Appointment of Officers
|
12 | |||
5.3. Subordinate Officers
|
12 | |||
5.4. Removal and Resignation of Officers
|
12 | |||
5.5. Vacancies in Offices
|
13 | |||
5.6. Chief Executive Officer
|
13 | |||
5.7. President
|
13 | |||
5.8. Vice Presidents
|
13 | |||
5.9. Secretary
|
13 | |||
5.10. Chief Financial Officer
|
14 | |||
5.11. Representation of Shares of Other Corporations
|
14 | |||
5.12. Authority and Duties of Officers
|
14 | |||
ARTICLE VI. INDEMNIFICATION OF DIRECTORS, OFFICERS, EMPLOYEES, AND OTHER AGENTS
|
15 | |||
6.1. Indemnification of Directors and Officers
|
15 | |||
6.2. Indemnification of Others
|
15 | |||
6.3. Payment of Expenses in Advance
|
15 | |||
6.4. Indemnity Not Exclusive
|
15 | |||
6.5. Insurance
|
16 | |||
6.6. Conflicts
|
16 | |||
ARTICLE VII. RECORDS AND REPORTS
|
16 | |||
7.1. Maintenance and Inspection of Records
|
16 | |||
7.2. Inspection by Directors
|
17 | |||
ARTICLE VIII. GENERAL MATTERS
|
17 | |||
8.1. Checks
|
17 | |||
8.2. Execution of Corporate Contracts and Instruments
|
17 | |||
8.3. Stock Certificates; Partly Paid Shares
|
17 | |||
8.4. Special Designation on Certificates
|
18 | |||
8.5. Lost Certificates
|
18 | |||
8.6. Construction; Definitions
|
19 |
ii
8.7. Dividends
|
19 | |||
8.8. Fiscal Year
|
19 | |||
8.9. Seal
|
19 | |||
8.10. Transfer of Stock
|
19 | |||
8.11. Stock Transfer Agreements
|
19 | |||
8.12. Registered Stockholders
|
20 | |||
8.13. Facsimile Signatures
|
20 | |||
ARTICLE IX. AMENDMENTS
|
20 |
iii
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
2
3
4
5
6
7
8
9
10
|
Company: | 200 Connell Drive #1500 |
|
Berkeley Heights, NJ 07922 | |
|
Attention: Chairman of the Board | |
|
||
|
Executive: | c/o Cyclacel Pharmaceuticals, Inc. |
|
200 Connell Drive #1500 | |
|
Berkeley Heights, NJ 07922 |
11
12
13
CYCLACEL PHARMACEUTICALS, INC. | |||||||||||||
|
|||||||||||||
|
By: | /s/ Dr. David UPrichard | |||||||||||
|
Name: | Dr. David UPrichard | |||||||||||
|
|
||||||||||||
|
Title: | Chairman of the Board of Directors | |||||||||||
|
|
||||||||||||
|
|||||||||||||
SPIRO ROMBOTIS | |||||||||||||
|
/s/ Spiro Rombotis | ||||||||||||
14
** |
Claims under any state or federal discrimination, fair employment practices or
other employment related statute, regulation or executive order (as they may have been
amended through the Execution Date) prohibiting discrimination or harassment based upon
any protected status including, without limitation, race, national origin, age, gender,
marital status, disability, veteran status or sexual orientation. Without limitation,
specifically included in this paragraph are any Claims arising under the Age
Discrimination in Employment Act, Title VII of the Civil Rights Act of 1964, the Civil
Rights Act of 1991, the Americans With Disabilities Act and any similar Federal and
state statute.
|
** |
Claims under any other state or federal employment related statute, regulation
or executive order (as they may have been amended through the Execution Date) relating
to wages, hours or any other terms and conditions of employment.
|
** |
Claims under any state or federal common law theory including, without
limitation, wrongful discharge, breach of express or implied contract, promissory
estoppel, unjust enrichment, breach of a covenant of good faith and fair dealing,
violation of public policy, defamation, interference with contractual relations,
intentional or negligent infliction of emotional distress, invasion of privacy,
misrepresentation, deceit, fraud or negligence.
|
** |
Any other Claim arising under state or federal law.
|
1/ |
For purposes of this Agreement, the Company includes
the Company and any of its divisions, affiliates (which means all persons and
entities directly or indirectly controlling, controlled by or under common
control with the Company), subsidiaries and all other related entities, and its
and their directors, officers, employees, trustees, agents, successors and
assigns.
|
15
|
By: | |||||||
Spiro Rombotis | ||||||||
|
||||||||
Date signed: | ||||||||
|
|
16
2
3
4
5
6
7
8
9
Company:
|
200 Connell Drive #1500 | |
|
Berkeley Heights, NJ 07922 | |
|
Attention: Chairman of the Board | |
|
||
Executive:
|
c/o Cyclacel Pharmaceuticals, Inc. | |
|
200 Connell Drive #1500 | |
|
Berkeley Heights, NJ 07922 |
10
11
CYCLACEL PHARMACEUTICALS, INC.: | ||||||||||||
|
||||||||||||
|
By: | /s/ Dr. David UPrichard | ||||||||||
|
Name: | Dr. David UPrichard | ||||||||||
|
|
|||||||||||
|
Title: | Chairman of the Board of Directors | ||||||||||
|
|
|||||||||||
|
||||||||||||
PAUL MCBARRON: | ||||||||||||
|
/s/ Paul McBarron | |||||||||||
12
** |
Claims under any state or federal discrimination, fair employment practices or
other employment related statute, regulation or executive order (as they may have been
amended through the Execution Date) prohibiting discrimination or harassment based upon
any protected status including, without limitation, race, national origin, age, gender,
marital status, disability, veteran status or sexual orientation. Without limitation,
specifically included in this paragraph are any Claims arising under the Age
Discrimination in Employment Act, Title VII of the Civil Rights Act of 1964, the Civil
Rights Act of 1991, the Americans With Disabilities Act and any similar Federal and
state statute.
|
** |
Claims under any other state or federal employment related statute, regulation
or executive order (as they may have been amended through the Execution Date) relating
to wages, hours or any other terms and conditions of employment.
|
** |
Claims under any state or federal common law theory including, without
limitation, wrongful discharge, breach of express or implied contract, promissory
estoppel, unjust enrichment, breach of a covenant of good faith and fair dealing,
violation of public policy, defamation, interference with contractual relations,
intentional or negligent infliction of emotional distress, invasion of privacy,
misrepresentation, deceit, fraud or negligence.
|
** |
Any other Claim arising under state or federal law.
|
1/ |
For purposes of this Agreement, the Company includes
the Company and any of its divisions, affiliates (which means all persons and
entities directly or indirectly controlling, controlled by or under common
control with the Company), subsidiaries and all other related entities, and its
and their directors, officers, employees, trustees, agents, successors and
assigns.
|
A-1
|
By: | |||||||
Paul McBarron | ||||||||
|
||||||||
Date signed: | ||||||||
|
|
A-2
1. |
Claims against the Employer
|
a. |
The Executive asserts that the Executive may have the following particular claims (the
Asserted Claims
), and no other claims, against the Employer, its directors, officers or
employees, or against any associated company or person, or any affiliates of the Employer
(collectively, the
Affiliates
) arising from the Executives employment with the Employer
or the termination thereof:
|
i. |
Any claim for damages for breach of contract for notice or pay in lieu of
notice;
|
ii. |
Any claim for holiday pay; or payment of an accrued untaken holiday
entitlement;
|
iii. |
Any claim for outstanding pay, overtime, expenses, ex-gratia or discretionary
payments, use of Company vehicle, Directors fees, bonuses or commission and also
including a claim under the Equal Pay Act 1970 or Article 119 of the Treaty of Rome (as
amended by the Treaty of Amsterdam);
|
iv. |
A claim by the Executive for breach of contract by the Employer;
|
v. |
Any claim for unfair dismissal; or unfair constructive dismissal;
|
vi. |
Any claim for unlawful deduction from wages under Part II of the Employment
Rights Act 1996;
|
B-1
vii. |
Any claim for redundancy payment whether statutory or otherwise;
|
viii. |
Any claim for a failure to follow the statutory dispute resolution procedures
under the Employment Act 2002 and the Employment Act 2002 (Dispute Resolution)
Regulations 2004;
|
ix. |
Any claim for breach of the Working Time Regulations 1998 including non-payment
of holiday pay;
|
x. |
Any claim for failure to give a Statement of Main Terms and Conditions of
Employment or dispute resolution procedures in terms of Part I of the Employment Rights
Act 1996;
|
b. |
The Executive confirms that the Executives only claims or complaints against the
Employer or Affiliates are the Asserted Claims and that the Executive is aware of no other
claim or grounds to make a claim against the Employer or Affiliates in relation to any
other matters howsoever arising.
|
c. |
The Executive accepts the terms of this Agreement in full and final settlement of the
Asserted Claims and all other claims, complaints, costs, expenses or rights of action of
any kind, present, future or contingent, which the Executive may have against the Employer
or Affiliates, whether under statute, contract or at common law or under legislation or
directives of the European Union, arising from the Executives employment with the Employer
or the termination thereof, including, but not limited to:
|
i. |
Any claim for sex discrimination or victimisation, or harassment under the Sex
Discrimination Act 1975;
|
ii. |
Any claim for race discrimination or victimisation, or harassment under the
Race Relations Act 1976;
|
iii. |
Any claim for disability discrimination or victimisation or harassment under
the Disability Discrimination Act 1995;
|
iv. |
Any claim for discrimination, victimisation or harassment under the Employment
Equality (Sexual Orientation) Regulations 2003;
|
v. |
Any claim for discrimination, victimisation or harassment under the Employment
Equality (Religion or Belief) Regulations 2003;
|
vi. |
Any claim for discrimination, victimisation or harassment under the Employment
Equality (Age) Regulations 2006;
|
B-2
vii. |
Any claim for less favourable treatment, detriment, unfair dismissal or
victimisation under the Part Time Workers (Prevention of Less Favourable Treatment)
Regulations 2000;
|
viii. |
Any claim for less favourable treatment, detriment, unfair dismissal or
victimisation under the Fixed Term Executives (Prevention of Less Favourable Treatment)
Regulations 2002;
|
ix. |
Any claim under the National Minimum Wage Act 1998;
|
x. |
Any claim in relation to trade union membership, unfair dismissal or detriment
on the grounds they are a trade union member under the Trade Union and Labour Relations
(Consolidation) Act 1992;
|
xi. |
Any claim for a protective award under Trade Union and Labour Relations
(Consolidation) Act 1992;
|
xii. |
Any claim for harassment under the Protection from Harassment Act 1997;
|
xiii. |
Any claim under Part VII of the Transnational Information and Consultation of
Executives Regulations 1999;
|
xiv. |
Any claim for compensation under the Data Protection Act 1998;
|
xv. |
Any claim under Part VIII of the Information and Consultation of Executives
Regulations 2004;
|
xvi. |
Any claim for a protective award under the Transfer of Undertakings (Protection
of Employment) Regulations 2006;
|
xvii. |
Any claim for a guarantee payment in terms of Part III of the Employment
Rights Act 1996;
|
xviii. |
Any claim by the Executive that they have suffered a detriment on the grounds of
provisions relating to:
|
(a) |
health and safety;
|
||
(b) |
Sunday working;
|
||
(c) |
the Working Time Regulations 1998;
|
||
(d) |
undertaking duties of an Occupational Pension Scheme Trustee;
|
||
(e) |
undertaking duties as an Executive representative;
|
||
(f) |
time off work for study or training;
|
||
(g) |
protected disclosures;
|
||
(h) |
family leave;
|
||
(i) |
dependant leave;
|
||
(j) |
flexible working;
|
||
(k) |
enforcing or securing the benefit of or right conferred under
the Tax Credits Act 2002.
|
B-3
xix. |
Any claim for compensation under Section 80H of the Employment Rights Act 1996
(flexible working), but excluding any claims in relation to accrued pension rights or
any claims for damages for personal injuries, in respect of the latter of which the
Executive warrants that the Executive is not aware of any such claims.
|
d. |
The Executive warrants that, at the date of this Agreement, the Executive has not
issued any proceedings against the Employer or Affiliates, whether in an Employment
Tribunal or otherwise, and agrees to withdraw any such proceedings instituted on their
behalf.
|
e. |
If the waiver of the Asserted Claims or any other claims contained in this Clause is
judged to be void or unenforceable, but would be valid if any one or more of the waivers
were reduced, the waiver(s) shall be deemed to apply with such modification(s) as may be
necessary to make them valid and effective. Any such modification of any one waiver of a
claim shall not affect the validity of any other waiver of claim contained in this
contract.
|
2. |
Executive warranties
|
a. |
The Executive warrants that he is not aware of any matters relating his employment
which if disclosed to the Employer might affect the Employers decision to enter into this
Agreement.
|
b. |
The Executive warrants that the Executive has complied with all of his obligations to
the Employer and have not done or failed to do anything which would have allowed the
Employer to terminate the Executive employment with immediate effect.
|
3. |
Legal Advice
|
a. |
The Executive warrants to the Employer that before signing this Agreement the Executive
received independent legal advice from [________]
Solicitor, [_______] a qualified lawyer
(The Advisor), as to the terms and effects of this Agreement, and, in particular, its
effect on the Executives ability to pursue the Executives rights before an
Employment Tribunal or a Court. The Advisor has in force a Policy of Insurance covering
the risk of a claim by the Executive in respect of any loss arising in consequence of the
said legal advice.
|
B-4
b. |
The Executive warrants to the Employer that the Executive has provided the Advisor with
all available information which the Advisor requires or may require to advise whether the
Executive has any claims, and in particular any of the claims listed in Clause 1 of this
Agreement, against the Employer or Affiliates.
|
c. |
The Executive warrants to the Employer that the Advisor has advised the Executive that
on the basis of the information available to the Advisor the Executives only claims or
particular complaints against the Employer or Affiliates are the Asserted Claims and that
he has no other claim against the Employer whether statutory or otherwise.
|
4. |
Compliance with statutory provisions
|
a. |
The Executive declares and acknowledges that the Executive has carefully read and fully
understands all of the provisions of this Agreement and voluntarily agrees to and intends
to be legally bound by all its terms and in particular the Executive acknowledges that this
Agreement is a Compromise Agreement within the meaning of s.203(2)(f) of the Employment
Rights Act 1996 and that by entering into this Agreement the Executive has agreed not to
institute or continue any proceedings before an Employment Tribunal or the Courts arising
out of the termination of the Executives employment.
|
b. |
The Employer and the Executive agree and acknowledge that the conditions regulating
Compromise Agreements under Section 203(3) of the Employment Rights Act 1996, Section 288
of the Trade Union and Labour Relations (Consolidation) Act 1992; Section 77(4A) of the Sex
Discrimination Act 1975; Section 72(4A) of the Race Relations Act 1976; Schedule 3A of the
Disability Discrimination Act 1995 and Regulation 35(3) of the Working Time Regulations
1998, Section 49 of the National Minimum Wage Act 1998, Regulation 10 of the Fixed Term
Executives (Prevention of less favourable Treatment) Regulations 2002; Regulation 9 of the
Part Time Workers (Prevention of Less favourable Treatment) Regulations 2000, Schedule 4 of
the Employment Equality (Religion or Belief) Regulations 2003, Schedule 4 of the Employment
Equality (Sexual Orientation) Regulations 2003; Schedule 5 of the Employment Equality (Age)
Regulations 2006; Regulation 40 of the Information and Consultation of Executives
Regulations 2004; and Regulation 41 of the Transnational information and Consultation of
Executives Regulations 1998 all as maybe re-enacted or amended are intended to be and have
been satisfied and that the Executive has intimated the foregoing claims.
|
B-5
|
||
|
||
|
||
|
(Authorised Signatory) | |
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
They are subscribed by the Executive at
[_____]
on the ________ day of [_____] 20_____
in
the presence of the following witness:-
|
||
|
||
|
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B-6
1. |
I am a solicitor holding a current Practising Certificate.
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2. |
I have advised [Executive] of the terms and effects of the attached
Agreement and in particular its effect on the Executives ability to pursue a claim to an
Employment Tribunal and/or the Courts following its signing.
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3. |
I am not acting and have not acted in relation to this matter for [employer]
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4. |
There is in force a policy of insurance covering the risk of a claim by the Executive in
respect of loss arising in consequence of the advice I have given.
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5. |
The conditions regulating Compromise Agreements under Section 203(3) of the Employment Rights
Act 1996, Section 288 of the Trade Union and Labour Relations (Consolidation) Act 1992;
Section 77(4A) of the Sex Discrimination Act 1975; Section 72(4A) of the Race Relations Act
1976; Schedule 3A of the Disability Discrimination Act 1995 and Regulation 35(3) of the
Working Time Regulations 1998, Section 49 of the National Minimum Wage Act 1998, Regulation 10
of the Fixed Term Executives (Prevention of less favourable Treatment) Regulations 2002;
Regulation 9 of the Part Time Workers (prevention of Less favourable Treatment) Regulations
2000, Schedule 4 of the Employment Equality (Religion or Belief) Regulations 2003, Schedule 4
of the Employment Equality (Sexual Orientation) Regulations 2003; Schedule 5 of the Employment
Equality (Age) Regulations 2006; Regulation 40 of the Information and Consultation of
Executives Regulations 2004; and Regulation 41 of the Transnational Information and
Consultation of Executives Regulations 1998 have accordingly been satisfied.
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(Sgd.)
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Date | |||||||
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B-7
Exhibit 21
Cyclacel Pharmaceuticals, Inc.
List of Subsidiaries
Cyclacel Limited
ALIGN Pharmaceuticals, LLC
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/s/ Ernst & Young LLP |
1. | I have reviewed this report on Form 10-K for the year ended December 31, 2010 of Cyclacel Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act rules 13a-15(f) and 15d-15(f)), for the registrant and have: |
a) | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within that entity, particularly during the period in which this report is being prepared; |
b) | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements for external purposes in accordance with generally accepted accounting principles; |
c) | evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report on such evaluation; and |
d) | disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting: and |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the Registrants board of directors (or persons performing the equivalent functions): |
a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls over financial reporting. |
/s/ Spiro Rombotis
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President & Chief Executive Officer
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(Principal Executive Officer)
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1. | I have reviewed this report on Form 10-K for the year ended December 31, 2010 of Cyclacel Pharmaceuticals, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrants other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e) and internal control over financial reporting (as defined in Exchange Act rules 13a-15(f) and 15d-15(f)), for the registrant and have: |
a) | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within that entity, particularly during the period in which this report is being prepared; |
b) | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements for external purposes in accordance with generally accepted accounting principles; |
c) | evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report on such evaluation; and |
d) | disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the Registrants board of directors (or persons performing the equivalent functions): |
a) | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls over financial reporting. |
/s/ Paul McBarron
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Chief Operating Officer, Chief Financial Officer
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and Executive Vice President, Finance
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(Principal Financial Officer)
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(i) | the Annual Report on Form 10-K of the Company for the year ended December 31, 2010 (the Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and |
(ii) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: March 31, 2011
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/s/ Spiro Rombotis
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President & Chief Executive Officer |
(i) | the Annual Report on Form 10-K of the Company for the year ended December 31, 2010 (the Report) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and |
(ii) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: March 31, 2011
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/s/ Paul McBarron
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Chief Operating Officer, Chief Financial Officer | |||
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and Executive Vice President, Finance |