Cyclacel Pharmaceuticals, Inc. - Quarter Report: 2011 September (Form 10-Q)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2011
OR
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission files number 0-50626
CYCLACEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 91-1707622 | |
(State or Other Jurisdiction | (I.R.S. Employer | |
of Incorporation or Organization) | Identification No.) | |
200 Connell Drive, Suite 1500 | ||
Berkeley Heights, New Jersey | 07922 | |
(Address of principal executive offices) | (Zip Code) |
Registrants telephone number, including area code: (908) 517-7330
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files).
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting filer þ | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
As of November 14, 2011 there were 54,228,782 shares of the registrants common stock outstanding.
CYCLACEL PHARMACEUTICALS, INC.
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EX-31.1 | ||||||||
EX-31.2 | ||||||||
EX-32.1 | ||||||||
EX-32.2 | ||||||||
EX-101 INSTANCE DOCUMENT | ||||||||
EX-101 SCHEMA DOCUMENT | ||||||||
EX-101 CALCULATION LINKBASE DOCUMENT | ||||||||
EX-101 LABELS LINKBASE DOCUMENT | ||||||||
EX-101 PRESENTATION LINKBASE DOCUMENT |
2
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PART I. FINANCIAL INFORMATION
Item 1. | Financial Statements. |
CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s, except share amounts)
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s, except share amounts)
December 31, 2010 |
September 30, 2011 |
|||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 29,495 | $ | 27,675 | ||||
Inventory |
174 | 165 | ||||||
Prepaid expenses and other current assets |
1,382 | 941 | ||||||
Total current assets |
31,051 | 28,781 | ||||||
Property, plant and equipment (net) |
408 | 165 | ||||||
Total assets |
$ | 31,459 | $ | 28,946 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,723 | $ | 1,101 | ||||
Accrued liabilities and other current liabilities |
4,132 | 4,797 | ||||||
Warrants liability |
680 | 37 | ||||||
Total current liabilities |
6,535 | 5,935 | ||||||
Total liabilities |
6,535 | 5,935 | ||||||
Stockholders equity: |
||||||||
Preferred stock, $0.001 par value; 5,000,000 shares
authorized at December 31, 2010 and September 30,
2011; 1,213,142 shares issued and outstanding at
December 31, 2010 and September 30, 2011. Aggregate
preference in liquidation (including undeclared
cumulative dividends) of $13,344,562 and
$13,526,533 at December 31, 2010 and September 30,
2011, respectively |
1 | 1 | ||||||
Common stock, $0.001 par value; 100,000,000 shares
authorized at December 31, 2010 and September 30,
2011; 46,564,914 and 54,212,643 shares issued and
outstanding at December 31, 2010 and September 30,
2011, respectively |
47 | 55 | ||||||
Additional paid-in capital |
266,666 | 276,312 | ||||||
Accumulated other comprehensive loss |
31 | 49 | ||||||
Deficit accumulated during the development stage |
(241,821 | ) | (253,406 | ) | ||||
Total stockholders equity |
24,924 | 23,011 | ||||||
Total liabilities and stockholders equity |
$ | 31,459 | $ | 28,946 | ||||
The accompanying notes are an integral part of these consolidated financial statements.
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CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
(Unaudited)
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
(Unaudited)
Period from | ||||||||||||||||||||
August 13, 1996 | ||||||||||||||||||||
Three Months Ended | Nine Months Ended | (inception) to | ||||||||||||||||||
September 30, | September 30, | September 30, | ||||||||||||||||||
2010 | 2011 | 2010 | 2011 | 2011 | ||||||||||||||||
Revenues: |
||||||||||||||||||||
Collaboration and research and development revenue |
$ | | $ | | $ | 100 | $ | | $ | 3,100 | ||||||||||
Product revenue |
159 | 164 | 432 | 524 | 2,846 | |||||||||||||||
Grant revenue |
| | 16 | | 3,648 | |||||||||||||||
159 | 164 | 548 | 524 | 9,594 | ||||||||||||||||
Operating expenses: |
||||||||||||||||||||
Cost of goods sold |
76 | 95 | 310 | 273 | 1,665 | |||||||||||||||
Research and development |
1,469 | 2,066 | 4,968 | 7,005 | 183,598 | |||||||||||||||
Selling, general and administrative |
2,612 | 2,051 | 8,103 | 5,891 | 87,857 | |||||||||||||||
Goodwill and intangible impairment |
| | | | 7,934 | |||||||||||||||
Restructuring costs |
| | | | 2,634 | |||||||||||||||
Total operating expenses |
4,157 | 4,212 | 13,381 | 13,169 | 283,688 | |||||||||||||||
Operating loss |
(3,998 | ) | (4,048 | ) | (12,833 | ) | (12,645 | ) | (274,094 | ) | ||||||||||
Other income (expense): |
||||||||||||||||||||
Costs associated with aborted 2004 IPO |
| | | | (3,550 | ) | ||||||||||||||
Payment under guarantee |
| | | | (1,652 | ) | ||||||||||||||
Change in valuation of derivative |
| | | | (308 | ) | ||||||||||||||
Change in valuation of warrants |
73 | 440 | (443 | ) | 643 | 6,713 | ||||||||||||||
Warrant re-pricing |
| | | | (44 | ) | ||||||||||||||
Foreign exchange (losses)/gains |
(25 | ) | 28 | (63 | ) | (59 | ) | (4,314 | ) | |||||||||||
Interest income |
7 | 9 | 24 | 33 | 13,713 | |||||||||||||||
Interest expense |
(7 | ) | | (40 | ) | | (4,677 | ) | ||||||||||||
Total other income (expense) |
48 | 477 | (522 | ) | 617 | 5,881 | ||||||||||||||
Loss before taxes |
(3,950 | ) | (3,571 | ) | (13,355 | ) | (12,028 | ) | (268,213 | ) | ||||||||||
Income tax benefit |
143 | 126 | 506 | 443 | 18,322 | |||||||||||||||
Net loss |
(3,807 | ) | (3,445 | ) | (12,849 | ) | (11,585 | ) | (249,891 | ) | ||||||||||
Dividends on preferred ordinary shares |
| | | | (38,123 | ) | ||||||||||||||
Deemed dividend on convertible exchangeable preferred shares |
| | (2,915 | ) | | (3,515 | ) | |||||||||||||
Dividend on convertible exchangeable preferred shares |
(182 | ) | (182 | ) | (585 | ) | (546 | ) | (3,475 | ) | ||||||||||
Net loss applicable to common shareholders |
$ | (3,989 | ) | $ | (3,627 | ) | $ | (16,349 | ) | $ | (12,131 | ) | (295,004 | ) | ||||||
Net loss per share Basic and diluted |
$ | (0.11 | ) | $ | (0.07 | ) | $ | (0.47 | ) | $ | (0.25 | ) | ||||||||
Weighted average common shares outstanding |
37,030,436 | 53,711,678 | 35,125,522 | 48,981,743 | ||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
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CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In $000s)
(Unaudited)
(In $000s)
(Unaudited)
Period from | ||||||||||||
August 13, 1996 | ||||||||||||
Nine Months Ended | (inception) to | |||||||||||
September 30, | September 30, | |||||||||||
2010 | 2011 | 2011 | ||||||||||
Cash flows from operating activities: |
||||||||||||
Net loss |
$ | (12,849 | ) | $ | (11,585 | ) | $ | (249,891 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Accretion of interest on notes payable, net of amortization of debt premium |
| | 100 | |||||||||
Amortization of investment premiums, net |
| | (2,297 | ) | ||||||||
Change in valuation of derivative |
| | 308 | |||||||||
Change in valuation of warrants |
443 | (643 | ) | (6,713 | ) | |||||||
Warrant re-pricing |
| | 44 | |||||||||
Depreciation and amortization |
351 | 250 | 12,564 | |||||||||
Amortization of intangible assets |
| | 886 | |||||||||
Fixed asset impairment |
| | 221 | |||||||||
Goodwill and intangibles impairment |
| | 7,934 | |||||||||
Unrealized foreign exchange loss |
| (29 | ) | 7,718 | ||||||||
Deferred revenue |
| | (98 | ) | ||||||||
Compensation for warrants issued to non-employees |
| | 1,215 | |||||||||
Shares issued for IP rights |
| | 446 | |||||||||
(Gain) loss on disposal of property, plant and equipment |
(12 | ) | | 99 | ||||||||
Stock based compensation |
1,390 | 677 | 18,818 | |||||||||
Provision for restructuring |
| | 1,779 | |||||||||
Amortization of issuance costs of Preferred Ordinary C shares |
| | 2,517 | |||||||||
Changes in operating assets and liabilities: |
||||||||||||
Prepaid expenses, inventory and other current assets |
675 | 450 | 218 | |||||||||
Accounts payable, accrued liabilities and other current liabilities |
(2,300 | ) | 162 | (5,728 | ) | |||||||
Net cash used in operating activities |
(12,302 | ) | (10,718 | ) | (209,860 | ) | ||||||
Investing activities: |
||||||||||||
Purchase of ALIGN |
| | (3,763 | ) | ||||||||
Purchase of property, plant and equipment |
(8 | ) | (6 | ) | (8,837 | ) | ||||||
Proceeds from sale of property, plant and equipment |
35 | | 158 | |||||||||
Purchase of short-term investments |
| | (156,657 | ) | ||||||||
Redemptions of short-term investments, net of maturities |
| | 162,729 | |||||||||
Net cash provided by (used in) investing activities |
27 | (6 | ) | (6,370 | ) | |||||||
Financing activities: |
||||||||||||
Payment of capital lease obligations |
| | (3,719 | ) | ||||||||
Proceeds from issuance of ordinary and preferred ordinary shares, net of issuance costs |
| | 121,678 | |||||||||
Proceeds from issuance of common stock and warrants, net of issuance costs |
16,572 | 9,258 | 91,662 | |||||||||
Net proceeds from stock options and warrants exercised |
2,710 | 3 | 173 | |||||||||
Payment of preferred stock dividend |
| (364 | ) | (1,898 | ) |
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CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In $000s)
(Unaudited)
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In $000s)
(Unaudited)
Period from | ||||||||||||
August 13, 1996 | ||||||||||||
Nine Months Ended | (inception) to | |||||||||||
September 30, | September 30, | |||||||||||
2010 | 2011 | 2011 | ||||||||||
Repayment of government loan |
| | (455 | ) | ||||||||
Government loan received |
| | 414 | |||||||||
Loan received from Cyclacel Group Plc |
| | 9,103 | |||||||||
Proceeds of committable loan notes issued from shareholders |
| | 8,883 | |||||||||
Loans received from shareholders |
| | 1,645 | |||||||||
Cash and cash equivalents assumed on stock purchase |
| | 17,915 | |||||||||
Costs associated with stock purchase |
| | (1,951 | ) | ||||||||
Net cash provided by financing activities |
19,282 | 8,897 | 243,450 | |||||||||
Effect of exchange rate changes on cash and cash equivalents |
(18 | ) | 7 | 455 | ||||||||
Net increase (decrease) in cash and cash equivalents |
6,989 | (1,820 | ) | 27,675 | ||||||||
Cash and cash equivalents at beginning of period |
11,493 | 29,495 | | |||||||||
Cash and cash equivalents at end of period |
$ | 18,482 | $ | 27,675 | $ | 27,675 | ||||||
Supplemental disclosure of cash flows information: |
||||||||||||
Cash received during the period for: |
||||||||||||
Interest |
14 | 20 | 11,735 | |||||||||
Taxes |
1,067 | 688 | 18,210 | |||||||||
Cash paid during the period for: |
||||||||||||
Interest |
(155 | ) | | (1,914 | ) | |||||||
Schedule of non-cash transactions: |
||||||||||||
Acquisitions of equipment purchased through capital leases |
| | 3,470 | |||||||||
Issuance of common shares in connection with license agreements |
| | 592 | |||||||||
Issuance of ordinary shares on conversion of bridging loan |
| | 1,638 | |||||||||
Issuance of preferred ordinary C shares on conversion of
secured convertible loan notes and accrued interest |
| | 8,893 | |||||||||
Issuance of ordinary shares in lieu of cash bonus |
| | 164 | |||||||||
Issuance of other long term payable on ALIGN acquisition |
| | 1,122 |
The accompanying notes are an integral part of these consolidated financial statements.
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CYCLACEL PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION
Nature of Operations
Cyclacel Pharmaceuticals, Inc. (Cyclacel or the Company) is a development-stage
biopharmaceutical company dedicated to the development and commercialization of novel,
mechanism-targeted drugs to treat human cancers and other serious diseases. Cyclacels strategy is
to build a diversified biopharmaceutical business focused in hematology and oncology based on a
portfolio of commercial products and a development pipeline of novel drug candidates.
Cyclacels clinical development priorities are focused on sapacitabine in the following
indications:
| Acute myeloid leukemia, or AML, in the elderly; | ||
| Myelodysplastic syndromes, or MDS; and | ||
| Non-small cell lung cancer, or NSCLC. |
On January 11, 2011, the Company opened enrollment of the SEAMLESS pivotal Phase 3 trial for
the Companys sapacitabine oral capsules 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 a Special Protocol Assessment, or SPA, reached with the U.S. Food & Drug Administration, or
FDA. SEAMLESS is a randomized study against an active control drug with the primary objective of
demonstrating an improvement in overall survival. In October 2011, the independent Data Safety
Monitoring Board, or DSMB, of SEAMLESS recommended that the study should enter the randomized stage
as planned and, following this recommendation, the Company has
implemented an improvement in the SEAMLESS trial design, converting
it into a 2-arm from a 3-arm design. The Company received written
confirmation from the FDA that, following the modification in the
trial design, the previously agreed SPA agreement remains valid.
The Company has advanced two additional product candidates, seliciclib in Phase 2 for NSCLC
and nasopharyngeal cancer or NPC, and CYC116 in Phase 1 clinical development. The combination of
sapacitabine with seliciclib is also being evaluated in a Phase 1 clinical trial. The Company will
determine the feasibility of pursuing further development and/or partnering these assets depending
on the availability of funding and further clinical data. In addition, the Company markets directly
in the United States Xclair® Cream for radiation dermatitis and Numoisyn® Liquid and Numoisyn®
Lozenges for xerostomia.
As a development stage enterprise, substantially all efforts of the Company to date have been
devoted to performing research and development, conducting clinical trials, developing and
acquiring intellectual property and raising capital.
Basis of Presentation
The condensed consolidated balance sheet as of September 30, 2011, the condensed consolidated
statements of operations for the three and nine months ended September 30, 2011 and 2010 and for
the period from August 13, 1996 (inception) to September 30, 2011, and the condensed consolidated
statements of cash flows for the nine months ended September 30, 2011 and 2010 and for the period
from August 13, 1996 (inception) to September 30, 2011, and related disclosures contained in the
accompanying notes are unaudited. The condensed consolidated balance sheet as of December 31, 2010
is derived from the audited consolidated financial statements included in the Annual Report on Form
10-K for the year ended December 31, 2010 filed with the Securities and Exchange Commission
(SEC). The condensed consolidated financial statements are presented on the basis of accounting
principles that are generally accepted in the United States (GAAP) for interim financial
information and in accordance with the rules and regulations of the SEC; accordingly, they do not
include all the information and footnotes required by accounting principles generally accepted in
the United States for a complete set of financial statements. In the opinion of management, all
adjustments, which include only normal recurring adjustments, necessary to present fairly the
condensed consolidated balance sheet as of September 30, 2011, the results of operations for the
three and nine months ended September 30, 2011 and 2010 and for the period from August 13,
1996 (inception) to September 30, 2011, and the consolidated statements of cash flows for the nine
months ended September 30, 2011 and 2010 and for the period from August 13, 1996 (inception) to
September 30, 2011, have been made. The interim results for the three and nine months ended
September 30, 2011 are not necessarily indicative of the results to be expected for the year ending
December 31, 2011 or for any other year. The condensed consolidated financial statements should be
read in conjunction with the audited consolidated financial statements and the accompanying notes
included in the Companys Annual Report on Form 10-K for the year ended December 31, 2010 filed
with the SEC.
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Recent Developments
July 2011 Underwritten Offering
On July 7, 2011, the Company closed an underwritten offering for an aggregate of 7,617,646
units, at an offering price of $1.36 per unit, for gross proceeds of approximately $10.4 million.
Each unit consists of (i) one share of common stock and (ii) a five-year warrant to purchase 0.5 of
a share of common stock at an exercise price of $1.36 per share, exercisable beginning six months
after the date of issuance, or after January 7, 2012. The shares of common stock and warrants were
immediately separable and were issued separately such that no units were issued. The net proceeds,
after underwriting discounts and commissions and other fees and expenses, were approximately $9.3
million.
NASDAQ Notification
On September 16, 2011, the Company received a NASDAQ Staff Deficiency Letter indicating the
Company was not in compliance with the minimum bid price requirement for continued listing on the
NASDAQ exchange because the bid price for the Companys common stock had closed under $1.00 for 30
consecutive business days. The Company may achieve compliance if, at any time before March 14,
2012, the bid price of its common stock closes at $1.00 per share or more for a minimum of 10
consecutive business days. Failure to achieve compliance may result in the removal of Companys
common stock listing on the NASDAQ exchange.
Preferred Stock Dividend
On October 6, 2011, the Board of Directors (the Board) decided not to declare the quarterly
cash dividend on the Companys 6% Convertible Exchangeable Preferred Stock (Preferred Stock) with
respect to the third quarter of 2011 that would have otherwise been payable on November 1, 2011.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Consolidation
The accompanying condensed consolidated financial statements include the accounts of the
Company and its wholly-owned subsidiaries for the indicated periods. All significant intercompany
transactions and balances have been eliminated.
Use of Estimates
The preparation of financial statements in accordance with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets, liabilities and related
disclosures of contingent assets and liabilities at the date of the financial statements and the
reported amounts of income and expenses during the reporting period. The Company reviews its
estimates on an ongoing basis. The estimates are based on historical experience and on various
other assumptions that the Company believes to be reasonable under the circumstances. Actual
results may differ from these estimates.
Cash and Cash Equivalents
Cash and cash equivalents are stated at cost, which is substantially the same as fair value.
The Company considers all highly liquid investments with an original maturity of three months or
less at the
time of purchase to be cash equivalents. The Companys cash equivalents generally include
investments in money market funds and corporate commercial paper.
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Trade Accounts Receivable and Allowance for Doubtful Accounts
An allowance for doubtful accounts is provided, as necessary, on trade receivables based on
their respective aging categories and historical collection experience, taking into consideration
the type of payer, historical and projected collection outcomes, and current economic and business
conditions that could affect the collectability of the Companys receivables. The allowance for
doubtful accounts is reviewed, at a minimum, on a quarterly basis. Changes in the allowance for
doubtful accounts are recorded as an adjustment to bad debt expense within general and
administrative expenses. Material revisions to reserve estimates may result from adverse changes in
collection experience. The Company writes off accounts against the allowance for doubtful accounts
when reasonable collection efforts have been unsuccessful and it is likely the receivable will not
be recovered. At December 31, 2010 and September 30, 2011, all receivables were deemed collectible.
For the three months ended September 30, 2010 and 2011, approximately 92% and 87%,
respectively, of the Companys product sales in the United States were to three wholesalers,
respectively. For the nine months ended September 30, 2010 and 2011, approximately 88% and 89%,
respectively, of the Companys product sales in the United States were to three wholesalers,
respectively.
Inventory
Cyclacel values inventories at the lower of cost or market value. The Company determines cost
using the first-in, first-out method. As of December 31, 2010 and September 30, 2011, all
inventories were classified as finished goods. The Company analyzes its inventory levels at least
quarterly to identify any items that may expire prior to sale, inventory that has a cost basis in
excess of net realizable value, or inventory in excess of expected sales requirements. The
determination of whether or not inventory costs will be realizable requires estimates by the
Companys management. An important consideration in making this determination is future sales
forecasts. The Company writes down the value of inventory to the extent that inventory is expected
to expire before being sold or if the cost basis is in excess of net realizable value. If actual
market conditions are less favorable than those projected by management, additional inventory
write-downs may be required in future periods.
Revenue Recognition
Product sales
The Company recognizes revenue from product sales when persuasive evidence of an arrangement
exists; delivery has occurred or services have been rendered; the selling price is fixed or
determinable; and collectability is reasonably assured.
The Company offers a general right of return on these product sales, and has considered the
guidance in ASC 605-15, Revenue Recognition -Products (ASC 605-15) and ASC 605 -10 Revenue
Recognition Overall (ASC 605-10). Under these guidelines, the Company accounts for all product
sales using the sell-through method. Under the sell-through method, revenue is not recognized
upon shipment of product to distributors. Instead, the Company records deferred revenue at gross
invoice sales price and deferred cost of sales at the cost at which those goods were held in
inventory. The Company recognizes revenue when such inventory is sold through to pharmacies. To
estimate product sold through to pharmacies, the Company relies on third-party information,
including information obtained from significant distributors with respect to their inventory levels
and sell-through to pharmacies. The Company estimates product returns based on historical returns
experience and other factors that affect demand for the Companys products as well as the amount of
product subject to return.
Deferred revenue was $0.1 million at both September 30, 2010 and 2011. Deferred cost of goods
sold was approximately $27,000 and $20,000 at September 30, 2010 and 2011, respectively.
9
Table of Contents
Collaboration, research and development, and grant revenue
Certain of the Companys revenues are earned from collaborative agreements. The Company
recognizes revenue when persuasive evidence of an arrangement exists; delivery has occurred or
services have been rendered; the fee is fixed or determinable; and collectability is reasonably
assured. Determination of whether these criteria have been met is based on managements judgments
regarding the nature of the research performed, the substance of the milestones met relative to
those the Company must still perform, and the collectability of any related fees. Should changes in
conditions cause management to determine these criteria are not met for certain future
transactions, revenue recognized for any reporting period could be adversely affected.
Research and development revenues, which are earned under agreements with third parties for
contract research and development activities, are recorded as the related services are performed.
Milestone payments are non-refundable and recognized as revenue when earned, as evidenced by
achievement of the specified milestones and the absence of ongoing performance obligations. Any
amounts received in advance of performance are recorded as deferred revenue. None of the revenues
recognized to date are refundable if the relevant research effort is not successful.
Grant revenues from government agencies and private research foundations are recognized as the
related qualified research and development costs are incurred, up to the limit of the prior
approval funding amounts. All grants received are not refundable.
Clinical Trial Accounting
Data management and monitoring of all of the Companys clinical trials are performed by
contract research organizations (CROs) or clinical research associates (CRAs) in accordance
with the Companys standard operating procedures. Typically, CROs and some CRAs bill monthly for
services performed, and others bill based upon milestones achieved. The Company accrues unbilled
clinical trial expenses based on estimates of the level of services performed each period. Costs of
setting up investigational sites for participation in the Companys clinical trials are expensed
immediately as research and development expenses. Clinical trial site costs related to patient
enrollment are accrued as patients are entered into the trial and the patient data is recorded on
case report forms. Any initial payment made to the clinical trial site is recognized upon execution
of the clinical trial agreements and expensed as research and development expenses.
Research and Development Expenditures
Research and development expenses consist primarily of costs associated with the development
of the Companys product candidates, including as appropriate license and milestone payments,
compensation and other expenses for research and development personnel, supplies and development
materials, costs for consultants and related contract research, facility costs, amortization of
purchased technology and depreciation. Expenditures relating to research and development are
expensed as incurred.
Foreign currency and currency translation
Transactions that are denominated in a foreign currency are re-measured into the functional
currency at the current exchange rate on the date of the transaction. Any foreign
currency-denominated monetary assets and liabilities are subsequently re-measured at current
exchange rates, with gains or losses recognized as foreign exchange (losses)/gains in the statement
of operations.
The assets and liabilities of the Companys international subsidiary are translated from its
functional currency into United States dollars at exchange rates prevailing at the balance sheet
date. Average rates of exchange during the period are used to translate the statement of
operations, while historical rates of exchange are used to translate any equity transactions.
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Translation adjustments arising on consolidation due to differences between average rates and
balance sheet rates, as well as unrealized foreign exchange gains or losses arising from
translation of intercompany loans that are of a long-term-investment nature, are recorded in other
comprehensive income.
Derivative Instruments
Derivative financial instruments are measured at fair value. Significant judgments and
estimates are necessary in determining the fair value in the absence of quoted market values. These
estimates are based on valuation methodologies and assumptions deemed appropriate in the
circumstances. The use of different assumptions may have a material effect on the estimated fair
value amount and the Companys results of operations.
Fair Value Measurements
Inputs used to determine fair value of financial and non-financial assets and liabilities are
categorized using a fair value hierarchy that prioritizes observable and unobservable inputs into
three broad levels, from Level 1, which is the most reliable, to Level 3, which is the least
reliable (see Note 3 Fair Value Measurements). Management reviews the categorization of fair
value inputs on a periodic basis and may determine that it is necessary to transfer an input from
one level of the fair value hierarchy to another based on changes in events or circumstances, such
as a change in the observability of an input. Any such transfer will be recognized at the end of
the reporting period.
Income Taxes
The Company accounts for income taxes under the liability method. Under this method, deferred
tax assets and liabilities are determined based on the difference between the financial statement
and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the
differences are expected to affect taxable income. Valuation allowances are established when
necessary to reduce deferred tax assets to the amounts expected to be realized. The Companys
management has established a full valuation allowance against its deferred tax assets based on the
determination that it is not more likely than not that the Company will recognize the benefits of
those assets.
The Company adopted the guidance related to accounting for uncertainty in income taxes,
primarily codified in ASC 740, Income taxes (ASC 740). ASC 740 specifies the accounting for
uncertainty in income taxes recognized in a companys financial statements by prescribing a minimum
probability threshold a tax position is required to meet before being recognized in the financial
statements.
The Company records income tax benefits related to research and development tax credits, which
will be claimed from H. M. Revenue & Customs, the United Kingdoms taxation and customs authority,
with respect to qualifying research and development costs incurred in the same accounting period.
Stock-based Compensation
The Company grants stock options, restricted stock units and restricted stock to officers,
employees and directors under the 2006 Amended and Restated Equity Incentive Plan (2006 Plan),
which was approved on March 16, 2006 and subsequently amended and restated on April 14, 2008. The
Company also has outstanding options under various stock-based compensation plans for employees and
directors. These plans are described more fully in Note 6 Stock-Based Compensation. The
Company accounts for these plans under ASC 718, Compensation Stock Compensation (ASC 718).
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ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on
date of grant and recognition of compensation over the requisite service period for awards expected
to vest. The fair value of restricted stock and restricted stock units is determined based on the
number of shares granted and the quoted price of the Companys common stock on the date of grant.
The determination of grant-date fair value for stock option awards is estimated using the
Black-Scholes model, which includes variables such as the expected volatility of our share price,
the anticipated exercise behavior of our employees, interest rates, and dividend yields. These
variables are projected based on our historical data, experience, and other
factors. Changes in any of these variables could result in material adjustments to the expense
recognized for share-based payments. Such value is recognized as expense over the requisite service
period, net of estimated forfeitures, using the straight-line attribution method. The estimation of
stock awards that will ultimately vest requires judgment, and to the extent actual results or
updated estimates differ from current estimates, such amounts are recorded as a cumulative
adjustment in the period estimates are revised. The Company considers many factors when estimating
expected forfeitures, including type of awards granted employee class, and historical experience.
Actual results and future estimates may differ substantially from current estimates.
Segments
The Company has determined its reportable segments in accordance with ASC 280, Segment
Reporting (ASC 280) and related disclosures about products, services, geographic areas and major
customers. After considering its business activities and geographic reach, the Company has
concluded that it operates in just one operating segment being the discovery, development and
commercialization of novel, mechanism-targeted drugs to treat cancer and other serious disorders,
with development operations in two geographic areas, namely the United States and the United
Kingdom.
Net Loss per Common Share
The Company calculates net loss per common share in accordance with ASC 260, Earnings Per
Share (ASC 260). Basic and diluted net loss per common share were determined by dividing net
loss applicable to common stockholders by the weighted average number of common shares outstanding
during the period. The Companys potentially dilutive shares, which include outstanding common
stock options, restricted stock, restricted stock units, convertible preferred stock, and common
stock warrants, have not been included in the computation of diluted net loss per share for all
periods as the result would be anti-dilutive.
September 30, | September 30, | |||||||
2010 | 2011 | |||||||
Stock options |
3,129,177 | 3,538,302 | ||||||
Restricted stock and restricted stock units |
67,700 | 36,440 | ||||||
Convertible preferred stock |
516,228 | 516,228 | ||||||
Common stock warrants |
5,843,597 | 13,814,015 | ||||||
Total shares excluded from calculation |
9,556,702 | 17,904,985 | ||||||
See Note 6 Stock Based Compensation and Note 8 Stockholders Equity for additional
information.
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Comprehensive Income (Loss)
In accordance with ASC 220, Comprehensive Income (ASC 220) all components of comprehensive
income (loss), including net income (loss), are reported in the financial statements in the period
in which they are recognized. ASC 220 defines comprehensive income (loss) as the change in equity
during a period from transactions and other events and circumstances from nonowner sources. Net
income (loss) and other comprehensive income (loss), including foreign currency translation
adjustments, are reported, net of any related tax effect, to arrive at comprehensive income (loss).
No taxes were recorded on items of other comprehensive income.
Period from | ||||||||||||||||||||
August 13, 1996 | ||||||||||||||||||||
Three Months Ended | Nine Months Ended | (inception) to | ||||||||||||||||||
September 30, | September 30, | September 30, | ||||||||||||||||||
2010 | 2011 | 2010 | 2011 | 2011 | ||||||||||||||||
$000 | ||||||||||||||||||||
Net loss |
(3,807 | ) | (3,445 | ) | (12,849 | ) | (11,585 | ) | (249,891 | ) | ||||||||||
Translation adjustment |
(3,699 | ) | 2,368 | 302 | (458 | ) | 8,320 | |||||||||||||
Unrealized foreign exchange (loss) gain on intercompany loans |
3,627 | (2,358 | ) | (352 | ) | 476 | (8,271 | ) | ||||||||||||
Comprehensive loss |
(3,879 | ) | (3,435 | ) | (12,899 | ) | (11,567 | ) | (249,842 | ) | ||||||||||
Recent Accounting Pronouncements
In September 2011, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update (ASU) 2011-08, which amends the guidance in ASC 350-20, Intangibles-Goodwill and
Other-Goodwill (ASC 350-20). The guidance simplifies how companies test goodwill for impairment
by allowing companies to use a qualitative approach. The amendments in the ASU permit a company to
first assess qualitative factors to determine whether it is more likely than not that the fair
value of a reporting unit is less than its carrying amount as a basis for determining whether it is
necessary to perform the two-step goodwill impairment test described in ASC 350-20.The ASU is
effective for annual and interim goodwill impairment tests performed for fiscal years beginning
after December 15, 2011. Early adoption is permitted, including for annual and interim goodwill
tests performed as of a date before September 15, 2011, if a companys financial statements for the
most recent annual or interim period have not yet been issued. Adoption of the guidance is not
expected to have a material impact on the Companys consolidated financial statements.
In June 2011, the FASB issued Accounting Standards ASU 2011-05 to amend the guidance on the
presentation of comprehensive income in ASC 220 that would require companies to present a single
statement of comprehensive income or two separate but consecutive statements, a statement of
operations and a statement of comprehensive income. The proposed guidance would make the financial
statement presentation of comprehensive income more prominent by eliminating the alternative to
present comprehensive income within the statement of equity. The ASU will be effective for annual
periods beginning after December 15, 2011, although the FASB has recently issued a proposal to
defer the effective date of certain aspects of ASC 2011-5 indefinitely. Nonetheless, the adoption
of the guidance will not have a material impact on the Companys consolidated financial statements.
In May 2011, the FASB issued ASU 2011-04, which amends GAAP to conform to International
Financial Reporting Standards (IFRS) fair value measurement and disclosure requirements. The
amendments change the wording used to describe the requirements in GAAP for measuring fair value,
changes certain fair value measurement principles and enhances disclosure requirements. This
guidance is effective for annual periods beginning after December 15, 2011, applied prospectively.
Adoption of the guidance is not expected to have a material impact on the Companys consolidated
financial statements.
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3. FAIR VALUE MEASUREMENTS
As defined in ASC 820, fair value is based on the price that would be received to sell an
asset or paid to transfer a liability in an orderly transaction between market participants at the
measurement date. In order to increase consistency and comparability in fair value measurements,
ASC 820 establishes a fair value
hierarchy that prioritizes observable and unobservable inputs used to measure fair value into
three broad levels, which are described below:
| Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. | ||
| Level 2: Inputs other than quoted prices within Level 1 that are observable for the asset or liability, either directly or indirectly. | ||
| Level 3: Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. |
Financial assets and liabilities carried at fair value on a recurring basis as of December 31,
2010 are classified in the table below in one of the three categories described above:
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Cash equivalents |
29,066 | | | 29,066 | ||||||||||||
Warrants |
| | 680 | 680 | ||||||||||||
Total |
29,066 | | 680 | 29,746 | ||||||||||||
Financial assets and liabilities carried at fair value on a recurring basis as of September
30, 2011 are classified in the table below in one of the three categories described above:
Level 1 | Level 2 | Level 3 | Total | |||||||||||||
$000 | $000 | $000 | $000 | |||||||||||||
Cash equivalents |
24,014 | | | 24,014 | ||||||||||||
Warrants |
| | 37 | 37 | ||||||||||||
Total |
24,014 | | 37 | 24,051 | ||||||||||||
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Warrants Liability
The Company issued warrants to purchase shares of common stock under the registered direct
financing completed in February 2007. These warrants are classified as liabilities for accounting
purposes in accordance with ASC 815, Derivatives and Hedging (ASC 815). At the date of the
transaction, the fair value of the warrants of $6.8 million was determined utilizing the
Black-Scholes option pricing model utilizing the following assumptions: risk free interest rate
4.68%, expected volatility 85%, expected dividend yield 0%, and a contractual life of 7
years. The fair value of the warrant is being re-measured each reporting period, with a derivative
gain or loss recognized in the consolidated statement of operations. Such gains or losses will
continue to be reported until the warrants are exercised or expire. The Company used the
Black-Scholes option-pricing model with the following assumptions to value the warrants:
December 31, | September 30, | |||||||
2010 | 2011 | |||||||
Exercise price |
$ | 8.44 | $ | 8.44 | ||||
Expected term |
3.13 Yrs. | 2.38 Yrs. | ||||||
Risk free interest rate |
1.02 | % | 0.32 | % | ||||
Expected volatility |
121 | % | 106 | % | ||||
Expected dividend yield over expected term |
| |
During the three months ended September 30, 2010, the Company recognized the increase
in the value of warrants of approximately $0.1 million as a loss on the consolidated statement of
operations. During the three months ended September 30, 2011, the Company recognized the decrease
in the value of warrants of approximately $0.4 million as a gain on the consolidated statement of
operations. During the nine months ended September 30, 2010, the Company recognized the $0.4
million increase in the value of warrants as a loss on the consolidated statement of operations.
During the nine months ended September 30, 2011, the Company recognized the $0.6 million decrease
in the value of warrants as a gain on the consolidated statement of operations. The following table
reconciles the beginning and ending balance of Level 3 inputs for the nine months ended September
30, 2011:
Level 3 | ||||
$000 | ||||
Balance as of December 31, 2010 |
680 | |||
Gain from change in valuation of warrants liability reported in earnings |
(643 | ) | ||
Balance as of September 30, 2011 |
37 | |||
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4. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets consist of the following:
December 31, | September 30, | |||||||
2010 | 2011 | |||||||
($000s) | ||||||||
Research and development tax credit receivable |
660 | 429 | ||||||
Prepayments |
317 | 324 | ||||||
Accounts receivable |
104 | 102 | ||||||
Other current assets |
301 | 86 | ||||||
Total prepaid expenses and other current assets |
1,382 | 941 | ||||||
5. ACCRUED LIABILITIES AND OTHER CURRENT LIABILITIES
Accrued and other current liabilities consisted of the following:
December 31, | September 30, | |||||||
2010 | 2011 | |||||||
($000s) | ||||||||
Accrued research and development |
2,793 | 3,807 | ||||||
Other current liabilities |
1,339 | 990 | ||||||
4,132 | 4,797 | |||||||
6. STOCK BASED COMPENSATION
Stock based compensation has been reported within expense line items on the consolidated
statement of operations for the three and nine month periods ended September 30, 2010 and 2011 as
shown in the following table:
For the three months | For the nine months | |||||||||||||||
ended September 30, | ended September 30, | |||||||||||||||
2010 | 2011 | 2010 | 2011 | |||||||||||||
($000s) | ||||||||||||||||
Research and development |
116 | 39 | 281 | 130 | ||||||||||||
General and administrative |
488 | 182 | 1,109 | 547 | ||||||||||||
Stock-based compensation costs before income taxes |
604 | 221 | 1,390 | 677 | ||||||||||||
Under the 2006 Plan, 5,200,000 shares of the Companys common stock have been reserved. The
awards granted under the 2006 Plan have a maximum maturity of 10 years and generally vest over a
four-year period from the date of grant.
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A summary of activity for the options under the Companys 2006 Plan for the nine months ended
September 30, 2011 is as follows:
Weighted Average | ||||||||||||||||
Weighted | Remaining | Aggregate | ||||||||||||||
Average | Contractual | Intrinsic | ||||||||||||||
Options | Exercise Price | Term (years) | Value | |||||||||||||
(in $000s) | ||||||||||||||||
Options outstanding at December 31, 2010 |
3,489,932 | $ | 3.96 | 7.22 | 938 | |||||||||||
Granted |
199,500 | $ | 1.52 | |||||||||||||
Exercised |
(6,638 | ) | $ | 0.41 | ||||||||||||
Expired |
| |||||||||||||||
Cancelled / forfeited |
(144,492 | ) | $ | 6.23 | ||||||||||||
Options outstanding at September 30, 2011 |
3,538,302 | $ | 3.74 | 6.69 | 8 | |||||||||||
Unvested at September 30, 2011 |
788,405 | $ | 1.79 | 8.74 | 1 | |||||||||||
Vested and exercisable at September 30, 2011 |
2,749,897 | $ | 4.30 | 6.10 | 6 | |||||||||||
ASC 718 requires compensation expense associated with share-based awards to be recognized over
the requisite service period, which for the Company is the period between the grant date and the
date the award vests or becomes exercisable. Most of the awards granted by the Company (and still
outstanding), vest ratably over four years, with 1/4 of the award vesting one year from the date of
grant and 1/48 of the award vesting each month thereafter. However, certain awards made to
executive officers vest over three to five years, depending on the terms of their employment with
the Company. In addition, some recent awards made to other employees vest ratably over four years,
with 1/48 of the award vesting each month.
ASC 718 requires forfeitures to be estimated at the time of grant and revised, if necessary,
in subsequent periods if actual forfeitures differ from those estimates. This analysis is performed
quarterly and the forfeiture rate adjusted as necessary. Ultimately, the actual expense recognized
over the vesting period is based on only those shares that vest.
The Company used the Black-Scholes option-pricing model with the following assumptions for
stock option grants to employees and directors for the nine months ended September 30, 2010 and
2011:
For the nine months | ||||
ended September 30, | ||||
2010 | 2011 | |||
Expected term |
5 6Yrs | 5 6Yrs | ||
Risk free interest rate |
2.37 2.96% | 1.47 2.29% | ||
Expected volatility |
90 100% | 93 99% | ||
Expected dividend yield over expected term |
| | ||
Resulting weighted average grant fair
value |
$1.80 | $1.15 |
There were 199,500 options granted during the nine months ended September 30, 2011. For grants
made during the nine months ended September 30, 2010 and September 30, 2011, the expected term
assumption was estimated using past history of early exercise behavior and estimated expectations
of future exercise behavior. Starting with the December 2010 annual grants to the Companys
employees, the Company relied exclusively on its historical volatility as an input to the option
pricing model as the Companys management believes that this rate will be representative of future
volatility over the expected
term of the options. Prior to December 2010, because the Company had been publicly traded for
a limited period, the expected volatility assumption was based on the historical volatility of peer
companies over the expected term of the option awards.
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Estimates of pre-vesting option forfeitures are based on the Companys experience. For
outstanding options, the Company uses a forfeiture rate of 0 50% depending on when and to whom
the options are granted. The Company adjusts its estimate of forfeitures over the requisite service
period based on the extent to which actual forfeitures differ, or are expected to differ, from such
estimates. Changes in estimated forfeitures are recognized through a cumulative adjustment in the
period of change and may impact the amount of compensation expense to be recognized in future
periods.
The weighted average risk-free interest rate represents interest rate for treasury constant
maturities published by the Federal Reserve Board. If the term of available treasury constant
maturity instruments is not equal to the expected term of an employee option, Cyclacel uses the
weighted average of the two Federal Reserve securities closest to the expected term of the employee
option.
During the nine months ended September 30, 2011, 6,638 stock options were exercised resulting
in approximately $3,000 of cash proceeds to the Company. During the nine months ended September
30, 2010, there were 149,313 stock options exercised for proceeds of approximately $0.1 million. As
the Company presently has tax loss carry forwards from prior periods and expects to incur tax
losses in 2011, the Company is not able to benefit from the deduction for exercised stock options
in the current reporting period.
Restricted Stock
In November 2008, the Company issued restricted common stock to an employee subject to certain
forfeiture provisions. Specifically, one quarter of the award vested one year from the date of
grant and 1/48 of the award effectively vests each month thereafter. This restricted stock grant
is accounted for at fair value at the date of grant and an expense is recognized ratably over the
vesting term. Summarized information for the restricted stock grant for the nine months ended
September 30, 2011 is as follows:
Weighted Average Grant | ||||||||
Restricted Stock | Date Value Per Share | |||||||
Non-vested at December 31, 2010 |
23,954 | $ | 0.44 | |||||
Vested |
(9,378 | ) | $ | 0.44 | ||||
Non-vested at September 30, 2011 |
14,576 | $ | 0.44 |
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Restricted Stock Units
Restricted stock units were issued to senior executives of the Company in November 2008, which
entitle the holders to receive a specified number of shares of the Companys common stock over the
four year vesting term. A restricted stock unit grant is accounted for at fair value at the date
of grant which is equivalent to the market price of a share of the Companys common stock, and an
expense is recognized during the vesting term. There were no restricted stock unit grants prior to
November 2008. Summarized information for restricted stock grants for the nine months ended
September 30, 2011 is as follows:
Weighted Average Grant | ||||||||
Restricted Stock Units | Date Value Per Share | |||||||
Non-vested at December 31, 2010 |
35,931 | $ | 0.44 | |||||
Vested |
(14,067 | ) | $ | 0.44 | ||||
Non-vested at September 30, 2011 |
21,864 | $ | 0.44 |
7. COMMITMENTS AND CONTINGENCIES
Licensing Agreements
The Company has entered into licensing agreements with academic and research organizations.
Under the terms of these agreements, the Company has received licenses to technology and patent
applications. The Company is required to pay royalties on future sales of product employing the
technology or falling under claims of patent applications.
Pursuant to the Daiichi Sankyo license under which the Company licenses certain patent rights
for sapacitabine, its lead drug candidate, the Company is under an obligation to use reasonable
endeavors to develop a product and obtain regulatory approval to sell a product and has agreed to
pay Daiichi Sankyo an up-front fee, reimbursement for Daiichi Sankyos enumerated expenses,
milestone payments and royalties on a country-by-country basis. Under this agreement, aggregate
milestone payments totaling $11.7 million could be payable subject to achievement of all the
specific contractual milestones and the Companys decision to continue with these projects. The
up-front fee and certain past reimbursements have been paid and, as a result of the SEAMLESS trial
entering Phase 3 during the first quarter of 2011, $1.6 million was paid in July 2011. Following
these milestone payments, a further $10.0 million in aggregate milestone payments could be payable.
Royalties are payable in each country for the term of patent protection in the country or for ten
years following the first commercial sale of licensed products in the country, whichever is later.
Royalties are payable on net sales. Net sales are defined as the gross amount invoiced by the
Company or its affiliates or licensees, less discounts, credits, taxes, shipping and bad debt
losses. The agreement extends from its commencement date to the date on which no further amounts
are owed under it. If the Company wishes to appoint a third party to develop or commercialize a
sapacitabine-based product in Japan, within certain limitations, Daiichi Sankyo must be notified
and given a right of first refusal to develop and/or commercialize in Japan. In general, the
license may be terminated by the Company for technical, scientific, efficacy, safety, or commercial
reasons on six months notice, or twelve months, if after a launch of a sapacitabine-based product,
or by either party for material default. Effective July 11, 2011, the license agreement was amended
to irrevocably waive a termination right Daiichi Sankyo possessed under a provision of the
agreement that required the Company to obtain regulatory approval to sell sapacitabine in at least
one country by September 2011, and releases the Company from all claims and liability of any kind
arising under such provision. The amendment further provides that the royalty due from the Company
to Daiichi Sankyo on future net sales of sapacitabine be increased by a percentage between 1.25%
and 1.50% depending on the level of net sales of sapacitabine realized.
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Guarantee
On June 22, 2009, the Company amended the Agreement with Scottish Enterprise (SE) (the
Amendment), in order to allow the Company to implement a reduction of the Companys research
operations located in Scotland in exchange for the parties agreement to modify the payment terms
of the Agreement in the principal amount of £5 million (approximately $8.0 million at December 31,
2009), which SE had previously entered into with the Company. The Agreement provided for repayment
of up to £5 million in the event the Company significantly reduced its Scottish research
operations. Pursuant to the terms of the Amendment, in association with Cyclacels material
reduction in staff at its Scottish research facility, the parties agreed to a modified payment of
£1 million (approximately $1.7 million at June 22, 2009) payable in two equal tranches. On July 1,
2009, the first installment of £0.5 million (approximately $0.8 million) was paid and the remaining
amount of £0.5 million (approximately $0.8 million) was paid on January 6, 2010. In addition,
should a further reduction below current minimum staff levels be effectuated before July 2014
without SEs prior consent, the Company will guarantee approximately £4 million, the amount
potentially due to SE, which will be calculated as a maximum of £4 million less the market value of
the shares held by SE at the time of any further reduction in research facilities.
This arrangement is accounted for as a liability and is measured at fair value. Changes in
fair value are recognized in earnings. Due to the nature of the associated contingency and the
likelihood of occurrence, the Company has concluded the fair value of this liability was immaterial
as of December 31, 2010 and September 30, 2011.
Legal proceedings
On April 27, 2010, the Company was served with a complaint filed by Celgene Corporation in the
United States District Court for the District of Delaware seeking a declaratory judgment that four
of the Companys own patents, claiming the use of romidepsin injection in T-cell lymphomas, are
invalid and not infringed by Celgenes products, but directly involve the use and administration of
Celgenes ISTODAX® (romidepsin for injection) product. On June 17, 2010, the Company filed its
answer and counterclaims to the declaratory judgment complaint. The Company filed counterclaims
charging Celgene with infringement of each of the Companys four patents and seeking damages for
Celgenes infringement as well as injunctive relief. The four patents directly involve the use and
administration of Celgenes ISTODAX® (romidepsin for injection) product.
8. STOCKHOLDERS EQUITY
Preferred Stock
As of September 30, 2011, there were 1,213,142 shares of Preferred Stock issued and
outstanding at an issue price of $10.00 per share. Dividends on the Preferred Stock are cumulative
from the date of original issuance at the annual rate of 6% of the liquidation preference of the
Preferred Stock, payable quarterly on the first day of February, May, August and November,
commencing February 1, 2005. Any dividends must be declared by the Companys Board of Directors and
must come from funds that are legally available for dividend payments. The Preferred Stock has a
liquidation preference of $10 per share, plus accrued and unpaid dividends. Accrued and unpaid
dividends on Preferred Stock were $1.4 million, or $1.15 per each share of Preferred Stock, as of
September 30, 2011.
The Preferred Stock is convertible at the option of the holder at any time into the Companys
shares of common stock at a conversion rate of approximately 0.42553 shares of common stock for
each share of Preferred Stock based on a price of $23.50. During 2010, 833,671 shares of Preferred
Stock were converted into 1,655,599 shares of the Companys common stock, which is described in
more detail below. Since inception through September 30, 2011, holders have voluntarily converted
1,776,858 shares of Preferred Stock into common stock. The Company has reserved 516,228 shares of
common stock for issuance upon conversion of the remaining shares of Preferred Stock outstanding at
September 30, 2011. The converted shares of Preferred Stock have been retired and canceled and
shall upon cancellation be restored to the
status of authorized but unissued shares of preferred stock, subject to reissuance by the
Board of Directors as shares of Preferred Stock of one or more series.
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The Company may automatically convert the Preferred Stock into common stock if the closing
price of the Companys common stock has exceeded $35.25, which is 150% of the conversion price of
the Preferred Stock, for at least 20 trading days during any 30-day trading period, ending within
five trading days prior to notice of automatic conversion.
The Certificate of Designations governing the Preferred Stock provides that if the Company
fails to pay dividends on its Preferred Stock for six quarterly periods, holders of Preferred Stock
are entitled to nominate and elect two directors to the Companys Board of Directors. This right
accrued to the holders of Preferred Stock as of August 2, 2010 and two directors were nominated and
elected at the annual meeting held on May 24, 2011.
The Preferred Stock has no maturity date and no voting rights prior to conversion into common
stock, except under limited circumstances.
From November 6, 2007, the Company may, at its option, redeem the Preferred Stock in whole or
in part, out of funds legally available at the redemption prices per share stated below, plus an
amount equal to accrued and unpaid dividends up to the date of redemption:
Year from November 1, 2010 to October 31, 2011 |
$ | 10.24 | ||
Year from November 1, 2011 to October 31, 2012 |
$ | 10.18 | ||
Year from November 1, 2012 to October 31, 2013 |
$ | 10.12 | ||
Year from November 1, 2013 to October 31, 2014 |
$ | 10.06 | ||
November 1, 2014 and thereafter |
$ | 10.00 |
The Preferred Stock is exchangeable, in whole but not in part, at the option of the Company on
any dividend payment date beginning on November 1, 2005 (the Exchange Date) for the Companys 6%
Convertible Subordinated Debentures (Debentures) at the rate of $10 principal amount of
Debentures for each share of Preferred Stock. The Debentures, if issued, will mature 25 years after
the Exchange Date and have terms substantially similar to those of the Preferred Stock.
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Conversion of Convertible Preferred Stock
During the nine months ended September 30, 2010, Cyclacel entered into agreements to exchange
shares of the Companys Preferred Stock into shares of common stock. There were no such conversions
during the three months ended September 30, 2010 or during the nine months ended September 30,
2011. The table below provides details of the aggregate activities in 2010:
For the nine | ||||
months ended | ||||
September 30, | ||||
2010 | ||||
Preferred shares exchanged |
833,671 | |||
Common shares issued: |
||||
At stated convertible option |
354,752 | |||
Incremental shares issued under an inducement offer |
1,300,847 | |||
Total common shares issued |
1,655,599 | |||
ASC 260, EITF Topic D-42, The Effect of the Calculation of Earnings per Share for the
Redemption or Induced Conversion of Preferred Stock (ASC 260) requires that if convertible
preferred stock is converted to other securities pursuant to an inducement offer, the Company
should record the excess of (1) the fair value of all securities and other consideration
transferred to the holders of the convertible preferred stock and (2) the fair value of securities
issuable to the original conversion terms as an increase to net loss to arrive at a net loss
attributable to common shareholders. The stockholder received more shares of the Companys common
stock than would have been delivered pursuant to the original conversion terms of the Preferred
Stock, pursuant to a short term inducement offer. The excess of the fair value of the common stock
transferred to the stockholder over the carrying amount of the preferred stock in the Companys
balance sheet at the time of the transfer was considered to be an additional return to the holder
of the Preferred Stock. Specifically, the Company recorded deemed dividends related to the
additional shares issued under the exchange transactions of approximately $2.9 million for the nine
months ended September 30, 2010. There were no conversions during the three months ended September
30, 2011or during the nine months ended September 30, 2011.
Common Stock
July 2011 Underwritten Offering
On July 7, 2011, the Company closed an underwritten offering for an aggregate of 7,617,646
units, at an offering price of $1.36 per unit, for gross proceeds of approximately $10.4 million.
Each unit consists of (i) one share of common stock and (ii) a five-year warrant to purchase 0.5 of
a share of common stock at an exercise price of $1.36 per share, exercisable beginning six months
after the date of issuance. The shares of common stock and warrants were immediately separable and
were issued separately such that no additional units were issued. As of September 30, 2011, all
warrants issued to the investors were outstanding and have been classified as equity. The
transaction date fair value of the warrants was $3.5 million. Net proceeds of approximately $9.3
million, after underwriting discounts and commissions and other fees and expenses of approximately
$1.1 million, were allocated based on relative transaction date fair values in the following
manner: $6.8 million ($0.89 per share) and $2.5 million ($0.66 per warrant) to common shares and
warrants, respectively.
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October 2010 Private Placement
On October 7, 2010, the Company completed a private placement pursuant to which it sold
approximately $15.2 million of its units to several institutional investors, for net proceeds of
approximately $14.0 million. The units consist of one share of common stock and 0.5 of a warrant,
with each whole warrant representing the right to purchase one share of common stock at an exercise
price of $1.92 per share for a period of five years. As of September 30, 2011, all options and
warrants issued to the investors are outstanding and have been classified as equity. The investors
purchased a total of 8,323,190 units at a price of $1.82625 per unit. The investors also have the
right to acquire up to 4,161,595 additional units at a price of $1.67 per unit (for $6.9 million in
gross proceeds) at any time up to nine months after closing or by July 6, 2011. As of September 30,
2011, none of the additional units had been exercised and, as of July 6, 2011, the right to acquire
the additional units lapsed. The transaction date fair value of the warrants and additional
optional units was $5.1 million and $2.8 million, respectively. Net proceeds of approximately $14.0
million were allocated based on relative transaction date fair values in the following manner: $8.9
million ($1.07 per share), $3.3 million ($0.79 per warrant) and $1.8 million ($0.43 per optional
unit) to common shares, warrants and the additional optional units, respectively.
In connection with the October 2010 private placement, the Company granted to the investors
certain registration rights pursuant to a Registration Rights Agreement, dated October 7, 2010, in
which the Company agreed, among other things, to register all of the shares of common stock
acquired from the Company (including upon exercise of the warrants and/or the options) within
thirty calendar days after the Company becomes eligible to use a registration statement on Form
S-3, and use commercially reasonable efforts to have the registration statement declared effective
as promptly as practicable thereafter. Upon the Companys failure to comply with the terms of the
Registration Rights Agreement and certain other conditions, the Company will be required to make
pro rata payments to each investor, as liquidated damages, in an amount equal to 1.5% of the
aggregate purchase price paid by such investor. The Company also agreed to other customary
obligations regarding registration, including indemnification and maintenance of the effectiveness
of the registration statement. The Company is currently in compliance with the applicable terms of
the Registration Rights Agreement, and the securities that were registrable under the terms of the
Registration Rights Agreement are currently subject to an effective registration statement.
January 2010 Registered Direct Financings
On January 25, 2010, the Company completed the sale of 2,350,000 units in a registered
direct offering at a purchase price of $2.50 per unit to certain institutional investors of the
Company for gross proceeds of approximately $5.9 million. Each unit consisted of one share of the
Companys common stock and one warrant to purchase 0.30 of one share of its common stock. The
warrants have a five-year term from the date of issuance, are exercisable beginning six months from
the date of issuance at an exercise price of $2.85 per share of common stock. As of September 30,
2011, warrants issued to the investors have been classified as equity. The transaction date fair
value of the warrants of $1.0 million was determined utilizing the Black-Scholes option pricing
model utilizing the following assumptions: risk free interest rate 2.39%, expected volatility -
90%, expected dividend yield 0%, and a remaining contractual life of 5.00 years. As of September
30, 2011, all the warrants are outstanding. Net proceeds of approximately $5.4 million were
allocated based on relative transaction date fair values in the following manner: $4.5 million
($1.93 per share) to common shares and $0.9 million ($1.29 per warrant) to the warrants.
On January 13, 2010, the Company completed the sale of 2,850,000 units in a registered
direct offering to certain institutional investors. Each unit was sold at a purchase price of
$2.51 per unit and consists of one share of the Companys common stock and one warrant to purchase
0.25 of one share of its common stock for gross proceeds of approximately $7.2 million. The
warrants have a five-year term from the date of issuance, are exercisable beginning six months from
the date of issuance at an exercise price of $3.26 per share of common stock. As of September 30,
2011, warrants issued to the investors have been classified as equity. The transaction date fair
value of the warrants of $1.3 million was determined utilizing the Black-Scholes option pricing
model utilizing the following assumptions: risk free interest rate 2.55%,
expected volatility 90%, expected dividend yield 0%, and a remaining contractual life of
5.00 years. As of September 30, 2011, all the warrants are outstanding. Net proceeds of
approximately $6.5 million were allocated based on relative transaction date fair values in the
following manner: $5.6 million ($1.95 per share) to common shares and $0.9 million ($1.32 per
warrant) to the warrants.
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July 2009 Registered Direct Financing
On July 29, 2009, the Company sold its securities to select institutional investors consisting
of 4,000,000 units in a registered direct offering at a purchase price of $0.85 per unit. Each
unit consisted of (i) one share of the Companys common stock, (ii) one warrant to purchase 0.625
of one share of common stock (a Series I Warrant) and (iii) one warrant to purchase 0.1838805 of
one share of common stock (a Series II Warrant). The Series I Warrants had a seven-month term
from the date of issuance, were exercisable beginning six months from the date of issuance at an
exercise price of $1.00 per share of common stock. During the first quarter of 2010, all of the
Series I Warrants were exercised for $2.5 million. The Series II Warrants have a five-year term
from the date of issuance, are exercisable beginning six months from the date of issuance at an
exercise price of $1.00 per share of common stock. During the first quarter of 2010, 43,266 common
shares were issued upon exercise of Series II Warrants with proceeds of $43,266. There were no
exercises during the nine months ended September 30, 2011.
The net proceeds to the Company from the sale of the units, after deducting for the placement
agents fees and offering expenses, were approximately $2.9 million. As of September 30, 2011, the
remaining Series II Warrants outstanding and exercisable into 692,256 of the Companys shares of
common stock have been classified as equity. The transaction date fair value of the Series II
Warrants of $0.6 million was determined utilizing the Black-Scholes option pricing model utilizing
the following assumptions: risk free interest rate 2.69%, expected volatility 90%, expected
dividend yield 0%, and a remaining contractual life of 5.00 years.
December 2007 Committed Equity Financing Facility
On December 10, 2007 and as amended on November 24, 2009, Cyclacel entered into a Committed
Equity Financing Facility, or CEFF, with Kingsbridge, in which Kingsbridge committed to purchase
the lesser of 4,084,590 shares of common stock or $60 million of common stock from Cyclacel over a
three-year period. The CEFF lapsed on December 10, 2010.
During March 2010, the Company sold 1,563,208 shares of its common stock to Kingsbridge under
the CEFF, in consideration of aggregate proceeds of $3.1 million. During December 2009 and January
2010, the Company sold an aggregate of 1,583,626 shares of its common stock to Kingsbridge under
the terms of the CEFF in consideration of an aggregate of $1.3 million, of which approximately $1.0
million was received in 2009, with the balance of $0.3 million in respect of common shares
subscribed but unissued at December 31, 2009, received by the Company in January 2010.
Common Stock Warrants
In connection with the Companys February 16, 2007 registered direct offering the Company
issued to investors warrants to purchase 1,062,412 shares of common stock. The warrants issued to
the investors are being classified as liabilities for accounting purposes. At the date of the
transaction, the fair value of the warrants of $6.8 million was determined utilizing the
Black-Scholes option pricing model utilizing the following assumptions: risk free interest rate -
4.58%, expected volatility 85%, expected dividend yield 0%, and a remaining contractual life of
6.88 years. The value of the warrant is being remeasured each reporting period as a derivative gain
or loss on the consolidated statement of operations until exercised or expiration. See Note 3
Fair Value for further details.
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The following table summarizes information about warrants outstanding at September 30, 2011:
Weighted | ||||||||||||
Expiration | Common Shares | Average | ||||||||||
Issued in Connection With | Date | Issuable | Exercise Price | |||||||||
April 2006 stock issuance |
2013 | 2,571,429 | $ | 7.00 | ||||||||
February 2007 stock issuance |
2014 | 1,062,412 | $ | 8.44 | ||||||||
December 2007 CEFF |
2013 | 100,000 | $ | 1.40 | ||||||||
July 2009 Series II stock issuance |
2014 | 692,256 | $ | 1.00 | ||||||||
January 2010 stock issuance |
2015 | 712,500 | $ | 3.26 | ||||||||
January 2010 stock issuance |
2015 | 705,000 | $ | 2.85 | ||||||||
October 2010 stock issuance |
2015 | 4,161,595 | $ | 1.92 | ||||||||
July 2011 stock issuance |
2016 | 3,808,823 | $ | 1.36 | ||||||||
Total |
13,814,015 | $ | 3.28 | |||||||||
Exercise of Stock Options
During the nine months ended September 30, 2011, there were 6,638 stock option exercises
totaling approximately $3,000. There were no exercises of stock options during three months ended
September 30, 2011.
9. SUBSEQUENT EVENTS
Preferred Stock Dividend
On October 6, 2011, the Board of Directors decided not to declare the quarterly cash dividend
on the Preferred Stock with respect to the third quarter of 2011 that would have otherwise been
payable on November 1, 2011.
The Board also did not declare the quarterly cash dividend with respect to each of the four
quarters of fiscal year 2009, the first, second and third quarters of 2010, and the second quarter
of 2011. To the extent that any dividends payable on the Preferred Stock are not paid, such unpaid
dividends are added to the liquidity preference of the Preferred Stock. As the Company elected not
to pay in an aggregate amount equal to at least six quarterly dividends (whether or not
consecutive) on the Preferred Stock, the size of the Companys Board was increased by two members
and the holders of the Preferred Stock, voting separately as a class, voted on May 24, 2011 and
elected two directors to fill the vacancies created thereby, which directorships shall terminate
when the Company pays all accrued but unpaid dividends.
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Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations. |
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q, including, without limitation, Managements Discussion and
Analysis of Financial Condition and Results of Operations, contains forward-looking statements
within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange
Act of 1934, as amended (the Exchange Act). We intend that the forward-looking statements be
covered by the safe harbor for forward-looking statements in the Exchange Act. The forward-looking
information is based on various factors and was derived using numerous assumptions. All statements,
other than statements of historical fact, that address activities, events or developments that we
intend, expect, project, believe or anticipate will or may occur in the future are forward-looking
statements. Such statements are based upon certain assumptions and assessments made by our
management in light of their experience and their perception of historical trends, current
conditions, expected future developments and other factors they believe to be appropriate. These
forward-looking statements are usually accompanied by words such as believe, anticipate,
plan, seek, expect, intend and similar expressions.
Forward-looking statements necessarily involve risks and uncertainties, and our actual results
could differ materially from those anticipated in the forward looking statements due to a number of
factors, including those set forth in Part I, Item 1A, entitled Risk Factors, of our Annual
Report on Form 10-K for the year ended December 31, 2010, as updated and supplemented by Part II,
Item 1A, entitled Risk Factors, of our Quarterly Reports on Form 10-Q and other reports we
publicly file with the Securities and Exchange Commission, or the SEC. These factors as well as
other cautionary statements made in this Quarterly Report on Form 10-Q, should be read and
understood as being applicable to all related forward-looking statements wherever they appear
herein. The forward-looking statements contained in this Quarterly Report on Form 10-Q represent
our judgment as of the date hereof. We encourage you to read those descriptions carefully. We
caution you not to place undue reliance on the forward-looking statements contained in this report.
These statements, like all statements in this report, speak only as of the date of this report
(unless an earlier date is indicated) and we undertake no obligation to update or revise the
statements except as required by law. Such forward-looking statements are not guarantees of future
performance and actual results will likely differ, perhaps materially, from those suggested by such
forward-looking statements. In this report, Cyclacel, the Company, we, us, and our refer
to Cyclacel Pharmaceuticals, Inc.
Overview
We are a biopharmaceutical company dedicated to the development and commercialization of
novel, mechanism-targeted drugs to treat human cancers and other serious diseases. Our strategy is
to build a diversified biopharmaceutical business focused in hematology and oncology based on a
portfolio of commercial products and a development pipeline of novel drug candidates.
Our clinical development priorities are focused on sapacitabine in the following indications:
| Acute myeloid leukemia, or AML, in the elderly; | ||
| Myelodysplastic syndromes, or MDS; and | ||
| Non-small cell lung cancer, or NSCLC. |
On January 11, 2011, we opened enrollment of the SEAMLESS pivotal Phase 3 trial for
sapacitabine oral capsules 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. SEAMLESS is a
registration-directed clinical trial and is conducted under a Special Protocol Assessment, or SPA,
agreement with the U.S. Food and Drug Administration, or FDA. SEAMLESS is a randomized study
against an active control drug with the primary objective of demonstrating an improvement in
overall survival. In October 2011, the independent Data Safety Monitoring Board, or DSMB, of
SEAMLESS recommended that the study should enter the
randomized stage as planned and, following this recommendation, we have implemented an
improvement in the SEAMLESS trial design converting it into a 2-arm from the original 3-arm design.
We received written confirmation from the FDA that, following the modification in the trial design,
the previously agreed SPA agreement remains valid.
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We have advanced two additional product candidates, seliciclib in Phase 2 for NSCLC and
nasopharyngeal cancer or NPC, and CYC116 in Phase 1 clinical development. The combination of
sapacitabine with seliciclib is also being evaluated in a Phase 1 clinical trial. We will
determine the feasibility of pursuing further development and/or partnering these assets depending
on the availability of funding and further clinical data. In addition, we market directly in the
United States Xclair® Cream for radiation dermatitis and Numoisyn® Liquid and Numoisyn® Lozenges
for xerostomia.
Recent Developments
Clinical
On October 13, 2011, we announced that the DSMB of SEAMLESS recommended that the study should
enter the randomized stage as planned. The DSMB reviewed available data from a total of 46 patients
receiving oral sapacitabine capsules, the Companys lead product candidate, administered in
alternating cycles with decitabine. The DSMB noted that no safety or efficacy concerns were
identified. The DSMB review was mandated in the SPA agreement that Cyclacel entered into with the
FDA with regard to the SEAMLESS study protocol. Of the 46 patients reviewed by the DSMB, 21 were
enrolled in the lead-in phase of SEAMLESS and 25 in an earlier pilot Phase 1/2 study using an
identical treatment regimen.
The regimen of the lead-in phase is considered tolerable, as the rate of dose-limiting
toxicity was 9.5% and the 8-week mortality rate was 14.3%. The criteria, as specified in the SPA,
are a dose-limiting toxicity less than 33% and an 8-week mortality rate of less than 37%.
Interim data from the pilot Phase 1/2 study, which was presented at the American Society of
Clinical Oncology (ASCO) Annual Meeting in June 2011, showed thirty-day mortality from all causes
was 4.5%; 60-day mortality from all causes was 9.5%. The overall response rate was 34.8%. An
additional 26.1% of patients stayed on study for more than 4 cycles with a decrease in bone marrow
blast counts despite not meeting criteria of response. Approximately 60.9% of patients received 4
or more cycles of the regimen. As reported at ASCO, no dose-limiting toxicities were observed in 21
patients treated with the regimen who have had at least 60 days of follow-up. The median age in the
group is 76 years (range 72-88). Common adverse events regardless of cause included anemia,
anorexia, dehydration, diarrhea, dyspnea, edema, hypocalcemia, nausea, febrile neutropenia,
neutropenia, pneumonia, thrombocytopenia, and weakness, which were mostly moderate in intensity.
On October 13, 2011, we announced updated data from 25 patients treated with the regimen and at
least 60 days follow-up that showed no dose-limiting toxicities and an 8-week mortality rate of
12.0%.
Financial
On September 16, 2011, we received a NASDAQ Staff Deficiency Letter indicating that we were
not in compliance with the minimum bid price requirement for continued listing on the NASDAQ
exchange because the bid price for our common stock had closed under $1.00 for 30 consecutive
business days. We may achieve compliance if, at any time before March 14, 2012, the bid price of
our stock closes at $1.00 per share or more for a minimum of 10 consecutive business days. Failure
to achieve compliance may result in the removal of our common stock listing on the NASDAQ exchange.
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Our pipeline and expertise in cell cycle biology
Our core area of expertise is in cell cycle biology and we focus primarily on the development
of orally-available anticancer agents that target the cell cycle with the aim of slowing the
progression or shrinking the
size of tumors, and enhancing the quality of life and improving survival rates of cancer
patients. We are generating several families of anticancer drug candidates that act on the cell
cycle including nucleoside analogues, cyclin dependent kinase, or CDK inhibitors and Aurora
kinase/Vascular Endothelial Growth Factor Receptor 2, or AK/VEGFR2 inhibitors. Although a number of
pharmaceutical and biotechnology companies are currently attempting to develop nucleoside
analogues, CDK inhibitor and AK inhibitor drugs, we believe that our drug candidates are
differentiated in that they are orally-available and interact with unique target profiles and
mechanisms. For example we believe that our sapacitabine is the only orally-available nucleoside
analogue to be tested in a Phase 3 trial for AML and in a Phase 2 trial in MDS and seliciclib is
the most advanced orally-available CDK inhibitor in Phase 2 trials.
Although our resources are primarily directed towards advancing our anticancer drug candidate
sapacitabine through in-house development activities we are also progressing, but with minimal
investment, our other novel drug series which are at earlier stages. As a consequence of our
progress in sapacitabine clinical development, research and development expenditures for the nine
months ended September 30, 2011 increased by $2.0 million, or approximately 40%, to $7.0 million,
compared to $5.0 million for the nine months ended September 30, 2010.
We have retained rights to commercialize our clinical development candidates and our business
strategy is to enter into selective partnership arrangements with these programs.
Our corporate headquarters is located in Berkeley Heights, New Jersey, with a research
facility located in Dundee, Scotland.
From our inception in 1996 through September 30, 2011, we have devoted substantially all our
efforts and resources to our research and development activities. We have incurred significant net
losses since inception. As of September 30, 2011, our accumulated deficit during the development
stage was approximately $253.4 million. We expect to continue incurring substantial losses for the
next several years as we continue to develop our clinical and preclinical drug candidates. Our
operating expenses are comprised of research and development expenses and selling and general and
administrative expenses.
To date, we have not generated significant product revenue but have financed our operations
and internal growth through, among other things, public and private equity offerings, licensing
revenue, interest on investments, government grants and research and development tax credits. Prior
to October 2007, our revenue consisted of collaboration and grant revenue. Beginning in 2008, we
recognized revenue from sales of commercial products, for the first time, following the ALIGN
acquisition in October 2007. We have recognized revenues from inception through September 30, 2011
totaling approximately $9.6 million, of which approximately $2.8 million is derived from product
sales, approximately $3.1 million from fees under collaborative agreements and approximately $3.6
million of grant revenue from various United Kingdom government grant awards.
Subsequent Events
Preferred Stock Dividend
On October 6, 2011, our Board of Directors, or Board, decided not to declare the quarterly
cash dividend on our 6% Convertible Exchangeable Preferred Stock, or Preferred Stock, with respect
to the second quarter of 2011 that would have otherwise been payable on November 1, 2011.
The Board also did not declare the quarterly cash dividend with respect to each of the four
quarters of fiscal year 2009, the first, second and third quarters of 2010, and the second quarter
of 2011. To the extent that any dividends payable on the Preferred Stock are not paid, such unpaid
dividends are added to the liquidity preference of the Preferred Stock. As we elected not to pay in
an aggregate amount equal to at least six quarterly dividends (whether or not consecutive) on the
Preferred Stock, the size of the our Board was increased by two members and the holders of the
Preferred Stock, voting separately as a class, voted on May 24, 2011 and elected two directors to
fill the vacancies created thereby, which directorships shall terminate when we pay all accrued but
unpaid dividends.
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Results of Operations
Three Months Ended September 30, 2011 and 2010
Revenues
The following table summarizes our revenue for the three months ended September 30, 2010
and 2011:
Three Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Product revenue |
$ | 159 | $ | 164 | $ | 5 | 3 | % | ||||||||
Total revenue |
$ | 159 | $ | 164 | $ | 5 | 3 | % | ||||||||
Product revenue is derived from the sale of Xclair® Cream, Numoisyn® Liquid and Numoisyn®
Lozenges following the ALIGN asset acquisition on October 5, 2007. During each of the three months
ended September 30, 2010 and 2011, we recognized revenue of approximately $0.2 million.
We had no collaboration and research and development revenue or grant revenue for the three
months ended September 30, 2011.
The future
We expect to continue to maintain the sales of ALIGN products in 2011 through the support of a
small sales and marketing infrastructure. We do not expect to earn any grant revenue during the
remainder of year, as no awards are expected during the year ended December 31, 2011.
Cost of goods sold
The following table summarizes cost of goods sold for the three months ended September 30,
2010 and 2011:
Three Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Cost of goods sold |
$ | 76 | $ | 95 | $ | 19 | 25 | % | ||||||||
Total cost of sales represented 48% of product revenue for the three months ended September
30, 2010 and 58% of product revenue for the three months ended September 30, 2011.
Research and development expenses
We expense all research and development costs as they are incurred. Research and development
expenses primarily include:
| 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. |
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The following table provides information with respect to our research and development
expenditure for the three months ended September 30, 2010 and 2011:
Three Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Sapacitabine |
$ | 1,189 | $ | 1,848 | $ | 659 | 55 | % | ||||||||
Seliciclib |
(12 | ) | 47 | 59 | 492 | % | ||||||||||
Other research and development costs |
292 | 171 | (121 | ) | (41 | )% | ||||||||||
Total research and development costs |
$ | 1,469 | $ | 2,066 | $ | 597 | 41 | % | ||||||||
Total research and development expenses represented 35% and 49% of our operating expenses for
the three months ended September 30, 2010 and 2011, respectively.
Research and development expenditure increased by $0.6 million to $2.1 million for the three
month period ended September 30, 2011 from $1.5 million for the three month period ended September
30, 2010. The increase in costs of $0.6 million is mostly due to a $0.7 million increase in
sapacitabine-related expenses, primarily a $0.3 million increase in clinical trial expenses and a
$0.4 million increase in clinical trial supplies as a result of the SEAMLESS trial entering Phase
3. Seliciclib costs increased $59,000, from a net credit of $12,000 for the three months ended
September 30, 2010, to $47,000 for the three months ended September 30, 2011, because
accrued liabilities were released in 2010 as we reconciled certain final study costs. Other
research and development costs decreased $0.1 million from approximately $0.3 million for the three
months ended September 30, 2010 to approximately $0.2 million for three months ended September 30,
2011 as we have continued to concentrate financial resources on the development of sapacitabine and
only selectively invest in other compounds.
The future
We will continue to concentrate our resources on the development of sapacitabine. We
anticipate that overall research and development expenditures in 2011 will increase as we enroll
the SEAMLESS pivotal Phase 3 trial.
Selling, general and administrative expenses
Selling, general and administrative expenses include costs for sales and marketing and
administrative personnel, legal and other professional expenses and general corporate expenses. The
following table summarizes the selling, general and administrative expenses for the three months
ended September 30, 2010 and 2011:
Three Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Selling, general and administrative |
$ | 2,612 | $ | 2,051 | $ | (561 | ) | (21 | )% | |||||||
Total selling, general and administrative expenses represented 63% and 49% of our operating
expenses for the three months ended September 30, 2010 and 2011, respectively. Our selling, general
and administrative expenditure decreased by $0.6 million from $2.6 million for the three months
ended September 30, 2010 to $2.0 million for the three months ended September 30, 2011. The
decrease of $0.6 million in expenses was primarily attributable to a net decrease in professional
and consultancy costs of $0.2 million, a decrease in stock compensation of $0.3 million, a decrease
in rent expense of $0.1 million, and a decrease in patent costs of $0.1 million.
The future
We expect our selling, general and administrative expenditures in 2011 to remain at lower
levels than our expenditures in 2010.
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Other income (expense)
The following table summarizes other income (expense) for the three months ended September 30,
2010 and 2011:
Three Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Other income (expense): |
||||||||||||||||
Change in valuation of warrants |
$ | 73 | $ | 440 | $ | 367 | 503 | % | ||||||||
Foreign exchange (losses)/gains |
(25 | ) | 28 | 53 | 212 | % | ||||||||||
Interest income |
7 | 9 | 2 | 29 | % | |||||||||||
Interest expense |
(7 | ) | | 7 | (100 | )% | ||||||||||
Total other income (expense) |
$ | 48 | $ | 477 | $ | 429 | 894 | % | ||||||||
Total
other income and expense, net, increased by approximately $0.4 million, from $48,000 for
the three months ended September 30, 2010, to $0.5 million for the three months ended September 30,
2011. The most significant impact is the change in the valuation of the warrant liability
described below.
The change in valuation of warrants relates to the issue of warrants to purchase shares of our
common stock under the registered direct financing completed in February 2007. The warrants issued
to the investors meet the requirements of and are being accounted for as a liability in accordance
with ASC 815, Derivatives and Hedging. The fair value of the
warrants is re-measured each reporting period with a derivative gain or loss recognized in the
consolidated statement of operations. Such gains or losses will continue to be reported until the
warrants are exercised or expired. For the three months ended September 30, 2010 and 2011, we
recorded gains as a result of the change in the value of warrants of $73,000 and a $0.4 million,
respectively.
Foreign exchange gains (losses) increased by $53,000 to a gain of $28,000 for the three months
ended September 30, 2011 compared to a loss of $25,000 for the three months ended September 30,
2010. Foreign exchange gains/(losses) are reported in the consolidated statement of operations as a
separate line item within other income (expense).
Interest income increased by approximately $2,000 to $9,000 for the three months to September
30, 2010 from $7,000 for the three months ended September 30, 2010. This is mostly attributed to a
higher average daily balance of cash and cash equivalents during the three months ended September
30, 2011 compared to the same period in 2010.
Interest expense was $7,000 for the three months ended September 30, 2010. We did not record
interest expense for three months ended September 30, 2011. This reduction was due to the
elimination of the accretion expense associated with the restructured Bothell lease, which expired
in December 2010.
The future
The valuation of the warrant liability will continue to be re-measured at the end of each
reporting period. The valuation of the warrants is dependent upon many factors, including our stock
price, interest rates and the remaining term of the instrument and may fluctuate significantly,
which may have a significant impact on our statement of operations.
Income tax benefit
Credit is taken for research and development tax credits, which are claimed from the United
Kingdoms revenue and customs authority, or HMRC, in respect of qualifying research and development
costs incurred.
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The following table summarizes research and development tax credits for the three months ended
September 30, 2010 and 2011:
Three Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Income tax benefit |
$ | 143 | $ | 126 | $ | (17 | ) | (12 | )% | |||||||
Research and development tax credits recoverable decreased by $17,000 to $0.1 million for the
three months ended September 30, 2011 from $0.1 million for three months ended September 30, 2010.
The level of tax credits recoverable is linked directly to qualifying research and development
expenditure incurred in any one year, but restricted to payroll taxes paid by us in the United
Kingdom in that same year. The $17,000 decrease between the three months ended September 30, 2010
and 2011 is due to lower payroll taxes paid as a result of lower headcount in 2011.
The future
We expect to continue to be eligible to receive United Kingdom research and development tax
credits for the foreseeable future and will elect to do so.
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Nine Months Ended September 30, 2010 and 2011
Revenues
The following table summarizes the components of our revenues for the nine months ended
September 30, 2010 and 2011:
Nine Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Collaboration and
research and development
revenue |
$ | 100 | $ | | $ | (100 | ) | (100 | )% | |||||||
Product revenue |
432 | 524 | 92 | 21 | % | |||||||||||
Grant revenue |
16 | | (16 | ) | (100 | )% | ||||||||||
Total revenue |
$ | 548 | $ | 524 | $ | (24 | ) | (4 | )% | |||||||
We recognized $0.1 million of collaboration and research and development revenue for the nine
months ended September 30, 2010 derived from an agreement with a pharmaceutical company under which
we provided one of our compounds for evaluation in the field of eye care. We had no collaboration
and research and development revenue for the nine months ended September 30, 2011.
Product revenue is derived from the sale of Xclair® Cream, Numoisyn® Liquid and Numoisyn®
Lozenges. During the nine months ended September 30, 2010 and 2011, we recognized product revenue
of approximately $0.4 and $0.5 million, respectively, in accordance with our revenue recognition
policy. Product revenue was lower by $0.1 million for the nine months ended September 30, 2010
compared to the same period in 2011 due to $0.2 million in product returns during nine month ended
September 30, 2010.
Grant revenue is recognized as we incur and pay for qualifying costs and services under the
applicable grant. Grant revenue is primarily derived from various European Union and United Kingdom
government grant awards. We recognized $16,000 in grant revenue for the nine months ended
September 30, 2010. We did not recognize any grant revenue for the nine months ended September 30,
2011 as our last grant was finalized in the first quarter of 2010.
Cost of goods sold
The following table summarizes cost of goods sold for the nine months ended September 30,
2010 and 2011:
Nine Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Cost of goods sold |
$ | 310 | $ | 273 | $ | (37 | ) | (12 | )% | |||||||
Total cost of
sales represented 72% and 52% of product revenue for the nine months ended
September 30, 2010 and 2011, respectively. The high percentage for the nine months ended September
30, 2010 is the result of lower product revenue driven by $0.2 million of product returns as
described in Revenues above.
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Research and development expenses
We expense all research and development costs as they are incurred. Research and development
expenses primarily include:
| 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. |
The following table provides information with respect to our research and development
expenditure for the nine months ended September 30, 2010 and 2011:
Nine Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Sapacitabine |
$ | 3,992 | $ | 6,579 | $ | 2,587 | 65 | % | ||||||||
Seliciclib |
121 | 72 | (49 | ) | (40 | )% | ||||||||||
Other research and development costs |
855 | 354 | (501 | ) | (59 | )% | ||||||||||
Total research and development
expenses |
$ | 4,968 | $ | 7,005 | $ | 2,037 | 41 | % | ||||||||
Total research and development expenses represented 37% and 53% of our operating expenses for
the nine months ended September 30, 2010 and 2011, respectively.
Research and development expenditure increased by $2.0 million to $7.0 million for the nine
month period ended September 30, 2011 from $5.0 million for the nine month period ended September
30, 2010. The increase in costs of $2.0 million is primarily due to a $2.6 million increase in
sapacitabine related costs and a $0.6 million decrease in other research and development costs,
respectively, as we continue to focus on the development of sapacitabine. The $2.6 million increase
in sapacitabine expenditures was primarily due to $1.6 million of contractual expenses, resulting
from an achievement of a milestone triggered by the opening of enrollment in our SEAMLESS trial,
pursuant to the Daiichi Sankyo license under which we license certain patent rights for
sapacitabine, a $0.8 million increase related to clinical trial supplies, and a $0.4 million
increase in clinical trial expenses. Seliciclib costs decreased by $49,000 from $121,000 for the
nine months ended September 30, 2010 to $72,000 for nine months ended September 30, 2011 primarily
due to the completion of clinical trials. Other research and development costs decreased $0.5
million to $0.4 million for the nine months ended September 30, 2011 from $0.9 million for the nine
months ended September 30, 2010, as we have concentrated financial resources on the development of
sapacitabine and reduced investment in other compounds.
Selling, general and administrative expenses
Selling, general and administrative expenses include costs for sales and marketing and
administrative personnel, legal and other professional expenses and general corporate expenses. The
following table summarizes the selling, general and administrative expenses for the nine months
ended September 30, 2010 and 2011:
Nine Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Selling, general and administrative |
$ | 8,103 | $ | 5,891 | $ | (2,212 | ) | (27 | )% | |||||||
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Total selling, general and administrative expenses represented 61% and 45% of our operating
expenses for the nine months ended September 30, 2010 and 2011, respectively. Our selling, general
and administrative expenditure decreased by $2.2 million from $8.1 million for the nine months
ended September 30, 2010 to $5.9 million for the nine months ended September 30, 2011. The decrease
of $2.2 million in expenses was primarily attributable to a net decrease in professional and
consultancy costs of $1.3 million, a decrease in salaries of $0.3 million, a decrease in rent of
$0.3 million as a result of the expiration our lease on a facility in Bothell, Washington in
December 2010, and a decrease in stock compensation of $0.6 million. These amounts were partially
offset by a $0.2 million increase in patent-related costs.
Other income (expense)
The following table summarizes other income (expense) for the three months ended September 30,
2010 and 2011:
Nine Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Other income (expense): |
||||||||||||||||
Change in valuation of warrants |
$ | (443 | ) | $ | 643 | $ | 1,086 | (245 | )% | |||||||
Foreign exchange (losses)/gains |
(63 | ) | (59 | ) | 4 | 6 | % | |||||||||
Interest income |
24 | 33 | 9 | 38 | % | |||||||||||
Interest expense |
(40 | ) | | 40 | (100 | )% | ||||||||||
Total other income (expense) |
$ | (522 | ) | $ | 617 | $ | 1,139 | (218 | )% | |||||||
Total other income and expense, net, increased by approximately $1.1 million, from an expense
of $0.5 million for the nine months ended September 30, 2010, to income of $0.6 million for the
nine months ended September 30, 2011. The most significant impact is the $1.1 million increase in
the change in the valuation of the warrant liability, mostly due to the decrease in our common
share price.
The change in valuation of warrants relates to the issue of warrants to purchase shares of our
common stock under the registered direct financing completed in February 2007. The warrants issued
to the investors are classified as liabilities in accordance with ASC 815, Derivatives and Hedging. The fair value of the warrants is re-measured each reporting
period with a derivative gain or loss recognized in the consolidated statement of operations. Such
gains or losses will continue to be reported until the warrants are exercised or expired. For the
nine months ended September 30, 2010 and 2011, the change in the valuation of warrants was a $0.5
million decrease and a $0.6 million increase, respectively.
Foreign
exchange gains (losses) increased by $4,000 to a loss of $59,000 for the nine months
ended September 30, 2011 compared to a loss of $63,000 for the nine months ended September 30,
2010. Foreign exchange gains/(losses) are reported in the consolidated statement of operations as a
separate line item within other income (expense).
Interest income increased by approximately $9,000 to $33,000 for the nine months ended
September 30, 2010 from $24,000 for the nine months ended September 30, 2010. This is mostly
attributed to a higher average daily balance of cash and cash equivalents during the three months
ended September 30, 2011 compared to the same period in 2010.
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Interest expense was $40,000 for the nine months ended September 30, 2010. We did not record
any interest expense for the nine months ended September 30, 2011. This reduction was due to the
elimination of the accretion expense associated with the restructured Bothell lease, which
expired in December 2010.
The future
The valuation of the warrant liability will continue to be re-measured at the end of each
reporting period. The valuation of the warrants is dependent upon many factors, including our stock
price, interest rates and the remaining term of the instrument and may fluctuate significantly,
which may have a significant impact on our statement of operations.
Income tax benefit
Credit is taken for research and development tax credits, which are claimed from the United
Kingdoms revenue and customs authority, or HMRC, in respect of qualifying research and development
costs incurred.
The following table summarizes research and development tax credits for the nine months ended
September 30, 2010 and 2011:
Nine Months Ended | ||||||||||||||||
September 30, | Increase (Decrease) | |||||||||||||||
2010 | 2011 | $ | % | |||||||||||||
($000s) | ||||||||||||||||
Income tax benefit |
$ | 506 | $ | 443 | $ | (63 | ) | (12 | )% | |||||||
Research and development tax credits recoverable decreased $0.1 million, from $0.5 million for
the nine months ended September 30, 2010, to $0.4 million for the nine months ended September 30,
2011. The level of tax credits recoverable is linked directly to qualifying research and
development expenditure incurred in any one year, but restricted to payroll taxes paid by us in the
United Kingdom in that same year. The $0.1 million decrease between the nine months ended September
30, 2010 and 2011 is due to lower payroll taxes paid as a result of lower headcount in 2011.
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Liquidity and Capital Resources
The following is a summary of our key liquidity measures at December 31, 2010 and September 30,
2011:
December 31, | September 30, | % | ||||||||||||||
2010 | 2011 | $ Difference | Difference | |||||||||||||
($000s) | ||||||||||||||||
Cash and cash equivalents |
$ | 29,495 | $ | 27,675 | $ | (1,820 | ) | (6 | )% | |||||||
Working capital: |
||||||||||||||||
Current assets |
$ | 31,051 | $ | 28,781 | $ | (2,270 | ) | (7 | )% | |||||||
Current liabilities |
(6,535 | ) | (5,935 | ) | 600 | (9 | )% | |||||||||
Working capital |
$ | 24,516 | $ | 22,846 | $ | (1,670 | ) | (7 | )% | |||||||
The objectives of our cash management policy are to safeguard and preserve funds, to maintain
liquidity sufficient to meet our cash flow requirements and to attain a market rate of return. At
September 30, 2011, we had cash and cash equivalents of $27.7 million as compared to $29.5 million
at December 31, 2010. The decrease in balance was primarily due to normal
cash outflows required to operate our business, offset by net proceeds of $9.3 million from the
July 2011 underwritten offering. Since our inception, we have not generated any significant revenue
and have relied primarily on the proceeds from sales of equity and preferred securities to finance
our operations and internal growth. Additional funding has come through interest on investments,
licensing revenue, government grants and research and development tax credits. We have incurred
significant losses since our inception. As of September 30, 2011, we had an accumulated deficit
during the development stage of $253.4 million. We believe that existing funds together with cash
generated from operations and recent financing activities are sufficient to satisfy our planned
working capital, capital expenditures, debt service and other financial commitments for at least
the next twelve months. Current business and capital market risks could have a detrimental effect
on the availability of sources of funding and our ability to access them in the future which may
delay or impede our progress of advancing our drugs currently in the clinic to approval by the FDA
for commercialization.
Cash provided by (used in) operating, investing and financing activities
Cash provided by (used in) operating, investing and financing activities for the nine months
ended September 30, 2010 and 2011, is summarized as follows:
Nine months ended September 30, | ||||||||
2010 | 2011 | |||||||
($000s) | ||||||||
Net cash used in operating activities |
(12,302 | ) | (10,718 | ) | ||||
Net cash provided by (used in) investing activities |
27 | (6 | ) | |||||
Net cash provided by (used in) financing activities |
19,282 | 8,897 |
Operating activities
Net cash used in operating activities decreased $1.6 million, from $12.3 million for the nine
months ended September 30, 2010 to $10.7 million for the nine months ended September 30, 2011. The
decrease in cash outflow is primarily the result of better management of selling, general and
administrative expenses as the result of our continued focus on sapacitabine.
Investing activities
Net cash provided by investing activities decreased $33,000, from an inflow of $27,000 for the
nine months ended September 30, 2010, as a result of the sale of laboratory equipment, to an
outflow of $6,000 during the nine months ended September 30, 2011 as a result of equipment
purchases.
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Financing activities
Net cash used in financing activities for the nine months ended September 30, 2011 was $8.9
million. Net cash provided by financing activities was $19.3 million for the nine months ended
September 30, 2010. During the nine months ended September 30, 2010, we completed two registered
direct offerings in January 2010 for gross proceeds of approximately $13.0 million, drew down the
Kingsbridge CEFF totaling approximately $2.8 million and had investors exercising warrants totaling
$2.7 million. During the nine months ended September 30, 2011, we received $9.3 million in net
financing proceeds and paid a cash dividend to our holders of the Preferred Stock of approximately
$0.4 million.
Operating Capital and Capital Expenditure Requirements
We expect to continue to incur substantial operating losses in the future. While we have
generated modest product revenues from ALIGN product sales from October 2007 through September 30,
2011, we do not expect to generate any significant product revenues until a product candidate has
been approved by the FDA or similar regulatory agencies in other countries and successfully
commercialized.
We currently anticipate that our cash and cash equivalents will be sufficient to fund our
operations for at least the next 12 months. We cannot be certain that any of our programs will be
successful or that we will be able to raise sufficient funds to complete the development and
commercialize any of our product candidates currently in development, should they succeed.
Additionally, we plan to continue to evaluate in-licensing and acquisition opportunities to gain
access to new drugs or drug targets that would fit with our strategy. Any such transaction would
likely increase our funding needs in the future.
Our future funding requirements will depend on many factors, including but not limited to:
| 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. |
Until we can generate a sufficient amount of product revenue to finance our cash requirements,
which we may never do, we expect to finance future cash needs primarily through public or private
equity offerings, debt financings or strategic collaborations. Although we are not reliant on
institutional credit finance and therefore not subject to debt covenant compliance requirements or
potential withdrawal of credit by banks, the current economic climate has also impacted the
availability of funds and activity in equity markets. We do not know whether additional funding
will be available on acceptable terms, or at all. If we are not able to secure additional funding
when needed, we may have to delay, reduce the scope of or eliminate one or more of our clinical
trials or research and development programs or make changes to our operating plan. In addition, we
may have to partner one or more of our product candidate programs at an earlier stage of
development, which would lower the economic value of those programs to us.
Off-Balance Sheet Arrangements
As of September 30, 2011, we have no off-balance sheet arrangements.
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Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations is based on
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United States. The preparation of these financial statements requires us
to make estimates and judgments that affect the reported amounts of assets, liabilities and
expenses and related disclosure of contingent assets and liabilities. We review our estimates on an
ongoing basis. We base our estimates on historical experience and on various other assumptions that
we believe to be reasonable under the circumstances. Actual results may differ from these estimates
under different assumptions or conditions. We believe the judgments and estimates required by the
following accounting policies to be critical in the preparation of our consolidated financial
statements.
Revenue Recognition
Product sales
We have adopted the following revenue recognition policy related to the sales of Xclair®
Cream, Numoisyn® Liquid and Numoisyn® Lozenges. We recognize revenue from these product sales when
persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered;
the selling price is fixed and determinable; and collectability is reasonably assured.
As we offer a general right of return on these product sales, we must consider the guidance in
ASC Topic 605. Under these guidelines, we account for all product sales using the sell-through
method. Under the sell-through method, revenue is not recognized upon shipment of product to
distributors. Instead, we record deferred revenue at gross invoice sales price and deferred cost of
sales at the cost at which those goods were held in inventory. We recognize revenue when such
inventory is sold through to pharmacies. To estimate products sold through to pharmacies, we rely
on third-party information, including information obtained from significant distributors with
respect to their inventory levels and sell-through to pharmacies. We estimate product returns based
on historical returns experience and other factors that affect the demand for our products as well
as the amount of product subject to return.
Stock-based Compensation
The Company grants stock options, restricted stock units and restricted stock to officers,
employees, directors and consultants under the Companys 2006 Amended and Restated Equity Incentive
Plan, which was amended and restated as of April 14, 2008. We also have outstanding options under
various stock-based compensation plans for employees and directors.
ASC 718 requires measurement of compensation cost for all stock-based awards at fair value on
date of grant and recognition of compensation over the requisite service period for awards expected
to vest. The fair value of restricted stock and restricted stock units is determined based on the
number of shares granted and the quoted price of our common stock on the date of grant. The
determination of grant-date fair value for stock option awards is estimated using an option-pricing
model, which includes variables such as the expected volatility of our share price, the anticipated
exercise behavior of our employees, interest rates, and dividend yields. These variables are
projected based on our historical data, experience, and other factors.
Such value is recognized as an expense over the requisite service period, net of estimated
forfeitures, using the straight-line attribution method. The estimation of stock awards that will
ultimately vest requires judgment, and to the extent actual results or updated estimates differ
from our current estimates, such amounts will be recorded as a cumulative adjustment in the period
estimates are revised. We consider many factors when estimating expected forfeitures, including
types of awards, employee class, and historical experience. If our actual forfeiture rate is
materially different from our estimate, the stock-based compensation expense could be significantly
different from what we have recorded in the current period.
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Warrants Liability
With respect to warrants issued in February 2007 as part of a financing and pursuant to ASC
815, since we are unable to control all the events or actions necessary to settle the warrants in
registered shares the warrants have been recorded as a current liability at fair value. The fair
value of the outstanding warrants is evaluated at each reporting period with any resulting change
in the fair value being reflected in the consolidated statements of operations. During the three
months ended September 30, 2010 and 2011, the Company recognized gains from the change in the value
of warrants of approximately $73,000 and $0.4 million, respectively. During the nine months ended
September 30, 2010, the Company recognized the change in the value of warrants as a loss of
approximately $0.4 million. During the nine months ended September 30, 2011, the Company recognized
the change in the value of warrants as a gain of approximately $0.6 million. Fair value is
estimated using an option-pricing model, which includes variables such as the expected volatility
of our share price, interest rates, and dividend yields. These variables are projected based on our
historical data, experience, and other factors. Changes in any of these variables could result in
material adjustments to the expense recognized for changes in the valuation of the warrants
liability.
Recently Issued Accounting Pronouncements
In September 2011, the Financial Accounting Standards Board (FASB) issued Accounting
Standards Update (ASU) 2011-08, which amends the guidance in ASC 350-20, Intangibles-Goodwill and
Other-Goodwill (ASC 350-20). The guidance simplifies how companies test goodwill for impairment
by allowing companies to use a qualitative approach. The amendments in the ASU permit a company to
first assess qualitative factors to determine whether it is more likely than not that the fair
value of a reporting unit is less than its carrying amount as a basis for determining whether it is
necessary to perform the two-step goodwill impairment test described in ASC 350-20.The ASU is
effective for annual and interim goodwill impairment tests performed for fiscal years beginning
after December 15, 2011. Early adoption is permitted, including for annual and interim goodwill
tests performed as of a date before September 15, 2011, if a companys financial statements for the
most recent annual or interim period have not yet been issued. Adoption of the guidance is not
expected to have a material impact on our consolidated financial statements.
In June 2011, the FASB issued Accounting Standards ASU 2011-05 to amend the guidance on the
presentation of comprehensive income in ASC 220 that would require companies to present a single
statement of comprehensive income or two separate but consecutive statements, a statement of
operations and a statement of comprehensive income. The proposed guidance would make the financial
statement presentation of comprehensive income more prominent by eliminating the alternative to
present comprehensive income within the statement of equity. The ASU will be effective for annual
periods beginning after December 15, 2011, although the FASB has recently issued a proposal to
defer the effective date of certain aspects of ASC 2011-5 indefinitely. Nonetheless, the adoption
of the guidance will not have a material impact on our consolidated financial statements.
In May 2011, the FASB issued ASU 2011-04, which amends GAAP to conform to International
Financial Reporting Standards (IFRS) fair value measurement and disclosure requirements. The
amendments change the wording used to describe the requirements in GAAP for measuring fair value,
changes certain fair value measurement principles and enhances disclosure requirements. This
guidance is effective for annual periods beginning after December 15, 2011, applied prospectively.
Adoption of the guidance is not expected to have a material impact on our consolidated financial
statements.
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk. |
We are exposed to market risk related to fluctuations in foreign currency exchange rates.
Foreign Currency Risk
We are exposed to foreign currency rate fluctuations related to the operation of our
subsidiary in the United Kingdom. At the end of each reporting period, income and expenses of the
subsidiary are translated
into U.S. dollars using the average currency rate in effect for the period and assets and
liabilities are translated into U.S. dollars using either historical rates or the exchange rate in
effect at the end of the period. Intercompany loans with this subsidiary are denominated in U.S.
dollars and unrealized foreign exchange gains and losses arising on these loans have been recorded
in the consolidated statement of operations within the separate line item foreign exchange
gains/(losses) within other income (expense) up to September 30, 2008.
We currently do not engage in foreign currency hedging. We enter into certain transactions
denominated in foreign currencies in respect of underlying operations and, therefore, we are
subject to currency exchange risks. We realized losses of $25,000 and
gains of $28,000 for the
three months ended September 30, 2010 and 2011, respectively. During the nine months ended
September 30, 2010 and 2011, we realized losses of $63,000 and
$59,000, respectively.
Common Stock Price Risk
In February 2007, we issued common stock and warrants. Pursuant to ASC 815, we recorded the
fair value of the warrants as a current liability. The fair value of the outstanding warrants is
remeasured at each reporting period with any resulting change in the fair value being reflected in
the condensed consolidated statements of operations. We recognized gains of $73,000 and $0.4
million on the consolidated statement of operations for the three months ended September 30, 2010
and 2011, respectively, related to the change in the value of warrants. We recognized a loss of
$0.4 million and a gain of $0.6 million on the consolidated statement of operations for the nine
months ended September 30, 2010 and 2011, respectively, related to the change in the value of
warrants. Fair value of the warrants will be affected by estimates of various factors that may
affect the respective instrument, including our stock price, the risk free rate of return and
expected volatility in the fair value of our stock price. As the fair value of this derivative may
fluctuate significantly from period to period, the resulting change in valuation may have a
significant impact on our results of operations.
Item 4. | Controls and Procedures |
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our management, including our principal
executive officer and principal financial and accounting officer, we conducted an evaluation of the
effectiveness, as of September 30, 2011, of our disclosure controls and procedures, as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the
Exchange Act. The purpose of this evaluation was to determine whether as of the evaluation date our
disclosure controls and procedures were effective to provide reasonable assurance that the
information we are required to disclose in our filings with the SEC under the Exchange Act (i) is
recorded, processed, summarized and reported within the time periods specified in the SECs rules
and forms and (ii) accumulated and communicated to our management, including our principal
executive officer and principal financial and accounting officer, as appropriate to allow timely
decisions regarding required disclosure. Based on that evaluation, management has concluded that as
of September 30, 2011, our disclosure controls and procedures were not effective at the reasonable
assurance level due to the material weaknesses in our internal controls described in the amendment
to our Annual Report on Form 10-K for the year ended December 31, 2010 in the section captioned
Item 9A Controls and Procedures Managements Annual Report on Internal Control Over
Financial Reporting that remain present.
Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting during the quarter
ended September 30, 2011 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting other than those described below.
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In response to the material weaknesses in our internal controls noted in our Annual Report on
Form 10-K for the year ended December 31, 2010, filed on March 31, 2011, management presented a
proposed remediation plan to our audit committee concerning our internal controls over financial
reporting, and the audit committee adopted managements remediation plan. We have implemented the
plan by hiring qualified finance professionals and retaining outside consultants. Remediation of
the material weaknesses will require management time and attention over the coming quarters and
will likely result in additional incremental expenses. Any failure on our part to remedy our
identified weaknesses or any additional errors or delays in our financial reporting would have a
material adverse effect on our business and results of operations and could have a substantial
adverse impact on the trading price of our common stock.
Subject to oversight by our board of directors, our chief executive officer will be
responsible for implementing managements internal control remediation plan, adopted by our audit
committee and approved by our board of directors.
Specifically, the remediation plan consists of strengthening the financial reporting function
through the hiring of qualified finance personnel, with experience in the interpretation and
application of accounting principles generally accepted in the United States, or GAAP, and
designing and placing into operation appropriate controls to prevent or detect on a timely basis
any potential material misstatements in the accounting, presentation and disclosure of cumulative
preferred dividends. It is anticipated that the remediation plan, once implemented, will
materially affect our internal control over financial reporting.
We anticipate that the actions described above will remediate the material weakness described
in our Annual Report on Form 10-K for the year ended December 31, 2010.
Inherent Limitation on the Effectiveness of Internal Controls
The effectiveness of any system of internal control over financial reporting, including ours,
is subject to inherent limitations, including the exercise of judgment in designing, implementing,
operating, and evaluating the controls and procedures, and the inability to eliminate misconduct
completely. Accordingly, any system of internal control over financial reporting, including ours,
no matter how well designed and operated, can only provide reasonable, not absolute assurances. In
addition, projections of any evaluation of effectiveness to future periods are subject to the risk
that controls may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate. We intend to continue to monitor and
upgrade our internal controls as necessary or appropriate for our business, but cannot assure you
that such improvements will be sufficient to provide us with effective internal control over
financial reporting.
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PART II. OTHER INFORMATION
Item 1. | Legal proceedings. |
From time to time, we may be involved in routine litigation incidental to the conduct of our
business. On April 27, 2010, we were served with a complaint filed by Celgene Corporation in the
United States District Court for the District of Delaware seeking a declaratory judgment that four
of our own patents, claiming the use of romidepsin injection in T-cell lymphomas, are invalid and
not infringed by Celgenes products, but directly involve the use and administration of Celgenes
ISTODAX® (romidepsin for injection) product. On June 17, 2010, we filed our answer and
counterclaims to the declaratory judgment complaint. We have filed counterclaims charging Celgene
with infringement of each of our four patents and seeking damages for Celgenes infringement as
well as injunctive relief. The four patents directly involve the use and administration of
Celgenes ISTODAX® (romidepsin for injection) product.
Item 1A. | Risk Factors. |
In analyzing our company, you should consider carefully the following risk factors, together
with all of the other information included in Part I, Item 1A. Risk Factors in our Annual Report
on Form 10-K for the year ended December 31, 2010. Factors that could cause or contribute to
differences in our actual results include those discussed in the following subsection, as well as
those discussed above in Managements Discussion and Analysis of Financial Condition and Results
of Operations and elsewhere throughout this Quarterly Report on Form 10-Q. Each of the following
risk factors, either alone or taken together, could adversely affect our business, operating
results and financial condition, as well as adversely affect the value of an investment in our
common stock.
Risks Associated with Development and Commercialization of Our Drug Candidates
Clinical trial designs that were discussed with the authorities prior to their commencement may
subsequently be considered insufficient for approval at the time of application for regulatory
approval. Thus, our SPA regarding our SEAMLESS trial does not guarantee marketing approval or
approval of our sapacitabine oral capsules for the treatment of acute myeloid leukemia.
On September 13, 2010, we reached agreement with the FDA regarding an SPA on the design of a
pivotal Phase 3 trial for our sapacitabine oral capsules as a front-line treatment in elderly
patients aged 70 years or older with newly diagnosed acute myeloid leukemia, or AML, who are not
candidates for intensive induction chemotherapy, or the SEAMLESS trial. An SPA provides trial
sponsors with an agreement from the FDA that the design and analysis of the trial adequately
address objectives in support of a submission for a marketing application if the trial is performed
according to the SPA. The SPA may only be changed through a written agreement between the sponsor
and the FDA or if the FDA becomes aware of a substantial scientific issue essential to product
efficacy or safety. On January 11, 2011, we opened enrollment of the SEAMLESS trial.
An SPA, however, neither guarantees approval nor provides any assurance that a marketing
application would be approved by the FDA. There are companies that have been granted SPAs but have
ultimately failed to obtain final approval to market their drugs. The FDA may revise previous
guidance or decide to ignore previous guidance at any time during the course of clinical activities
or after the completion of clinical trials. The FDA may raise issues relating to, among other
things, safety, study conduct, bias, deviation from the protocol, statistical power, patient
completion rates, changes in scientific or medical parameters or internal inconsistencies in the
data prior to making its final decision. The FDA may also seek the guidance of an outside advisory
committee prior to making its final decision. Even with successful clinical safety and efficacy
data, including such data from a clinical trial conducted pursuant to an SPA, we may be required to
conduct additional, expensive clinical trials to obtain regulatory approval.
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The development program for our lead drug candidate sapacitabine is based, in part, on intellectual
property rights we license from others and any termination of this license could seriously harm our
business.
Effective July 11, 2011, the Daiichi Sankyo license under which we license certain patent
rights for sapacitabine, our lead drug candidate, was amended to irrevocably waive a termination
right Daiichi Sankyo possessed under a provision of the agreement that required the Company to
obtain regulatory approval to sell sapacitabine in at least one country by September 2011, and
releases the Company from all claims and liability of any kind arising under such provision. The
amendment further provides that the royalty due from the Company to Daiichi Sankyo on future net
sales of sapacitabine be increased by a percentage between 1.25% and 1.50% depending on the level
of net sales of sapacitabine realized.
In general, the license may be terminated by us for technical, scientific, efficacy, safety,
or commercial reasons on six months notice, or twelve months if after a launch of a
sapacitabine-based product, or by either party for material default.
Although we are currently in compliance with all of our material obligations under this
license, if we were to breach any such obligations, our counterparty may be entitled to terminate
the license. This would restrict or delay or eliminate our ability to develop and commercialize
these drug candidates, which could adversely affect our business.
If we fail to enter into and maintain successful strategic alliances for our drug candidates, we
may have to reduce or delay our drug candidate development or increase our expenditures.
An important element of our strategy for developing, manufacturing and commercializing our
drug candidates is entering into strategic alliances with pharmaceutical companies or other
industry participants to advance our programs and enable us to maintain our financial and
operational capacity.
We face significant competition in seeking appropriate alliances. We may not be able to
negotiate alliances on acceptable terms, if at all. In addition, these alliances may be
unsuccessful. If we fail to create and maintain suitable alliances, we may have to limit the size
or scope of, or delay, one or more of our drug development or research programs. If we elect to
fund drug development or research programs on our own, we will have to increase our expenditures
and will need to obtain additional funding, which may be unavailable or available only on
unfavorable terms.
Clinical trials are expensive, time consuming, subject to delay and may be required to continue
beyond our available funding.
Clinical trials are expensive, complex, can take many years to conduct and may have uncertain
outcomes. We estimate that clinical trials of our most advanced drug candidates may be required to
continue beyond our available funding and may take several years more to complete. The designs used
in some of our trials have not been used widely by other pharmaceutical companies. Failure can
occur at any stage of the testing and we may experience numerous unforeseen events during, or as a
result of, the clinical trial process that could delay or prevent commercialization of our current
or future drug candidates, including but not limited to:
| 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; |
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| 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; | ||
| 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. |
If we suffer any significant delays, setbacks or negative results in, or termination of, our
clinical trials, we may be unable to continue development of our drug candidates or generate
revenue and our development costs could increase significantly. Adverse events have been observed
in our clinical trials and may force us to stop development of our product candidates or prevent
regulatory approval of our product candidates.
Adverse or inconclusive results from our clinical trials may substantially delay, or halt
entirely, any further development of our drug candidates. Many companies have failed to demonstrate
the safety or effectiveness of drug candidates in later stage clinical trials notwithstanding
favorable results in early stage clinical trials. Previously unforeseen and unacceptable side
effects could interrupt, delay or halt clinical trials of our drug candidates and could result in
the FDA or other regulatory authorities denying approval of our drug candidates. We will need to
demonstrate safety and efficacy for specific indications of use, and monitor safety and compliance
with clinical trial protocols throughout the development process. To date, long-term safety and
efficacy has not been demonstrated in clinical trials for any of our drug candidates. Toxicity and
serious adverse events as defined in trial protocols have been noted in preclinical and clinical
trials involving certain of our drug candidates. For example, neutropenia and gastro-intestinal
toxicity were observed in patients receiving sapacitabine and elevations of liver enzymes and
decrease in potassium levels have been observed in patients receiving seliciclib.
In addition, we may pursue clinical trials for sapacitabine and seliciclib in more than one
indication. There is a risk that severe toxicity observed in a trial for one indication could
result in the delay or suspension of all trials involving the same drug candidate. Even if we
believe the data collected from clinical trials of our drug candidates are promising with respect
to safety and efficacy, such data may not be deemed sufficient by regulatory authorities to warrant
product approval. Clinical data can be interpreted in different ways. Regulatory officials could
interpret such data in different ways than we do which could delay, limit or prevent regulatory
approval. The FDA, other regulatory authorities or we may suspend or terminate clinical trials at
any time. Any failure or significant delay in completing clinical trials for our drug candidates,
or in receiving regulatory approval for the commercialization of our drug candidates, may severely
harm our business and reputation.
If our understanding of the role played by CDKs or AKs in regulating the cell cycle is incorrect,
this may hinder pursuit of our clinical and regulatory strategy.
Our development of small molecule inhibitors of CDK and AK is based on our understanding of
the mechanisms of action of CDK and AK inhibitors and their interaction with other cellular
mechanisms. One of our drug candidates, seliciclib, is a CDK inhibitor, and CYC116 is an AK and
VEGFR2 inhibitor. Although a number of pharmaceutical and biotechnology companies are attempting to develop CDK
or AK inhibitor drugs for the treatment of cancer, no CDK or AK inhibitor has yet reached the
market. If our understanding of the role played by CDK or AK inhibitors in regulating the cell
cycle is incorrect, seliciclib and/or CYC116 may fail to produce therapeutically relevant results
hindering our ability to pursue our clinical and regulatory strategy.
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We are making use of biomarkers, which are not scientifically validated, and our reliance on
biomarker data may thus lead us to direct our resources inefficiently.
We are making use of biomarkers in an effort to facilitate our drug development and to
optimize our clinical trials. Biomarkers are proteins or other substances whose presence in the
blood can serve as an indicator of specific cell processes. We believe that these biological
markers serve a useful purpose in helping us to evaluate whether our drug candidates are having
their intended effects through their assumed mechanisms, and thus enable us to identify more
promising drug candidates at an early stage and to direct our resources efficiently. We also
believe that biomarkers may eventually allow us to improve patient selection in connection with
clinical trials and monitor patient compliance with trial protocols.
For most purposes, however, biomarkers have not been scientifically validated. If our
understanding and use of biomarkers is inaccurate or flawed, or if our reliance on them is
otherwise misplaced, then we will not only fail to realize any benefits from using biomarkers, but
may also be led to invest time and financial resources inefficiently in attempting to develop
inappropriate drug candidates. Moreover, although the FDA has issued for comment a draft guidance
document on the potential use of biomarker data in clinical development, such data are not
currently accepted by the FDA or other regulatory agencies in the United States, the European Union
or elsewhere in applications for regulatory approval of drug candidates and there is no guarantee
that such data will ever be accepted by the relevant authorities in this connection. Our biomarker
data should not be interpreted as evidence of efficacy.
Due to our reliance on contract research organizations or other third parties to conduct clinical
trials, we may be unable to directly control the timing, conduct and expense of our clinical
trials.
We do not have the ability to independently conduct clinical trials required to obtain
regulatory approvals for our drug candidates. We must rely on third parties, such as contract
research organizations, data management companies, contract clinical research associates, medical
institutions, clinical investigators and contract laboratories to conduct our clinical trials. In
addition, we rely on third parties to assist with our preclinical development of drug candidates.
If these third parties do not successfully carry out their contractual duties or regulatory
obligations or meet expected deadlines, if the third parties need to be replaced or if the quality
or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical
protocols or regulatory requirements or for other reasons, our preclinical development activities
or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to
obtain regulatory approval for or successfully commercialize our drug candidates.
To the extent we are able to enter into collaborative arrangements or strategic alliances, we will
be exposed to risks related to those collaborations and alliances.
Although we are not currently party to any collaboration arrangement or strategic alliance
that is material to our business, in the future we expect to be dependent upon collaborative
arrangements or strategic alliances to complete the development and commercialization of some of
our drug candidates particularly after the Phase 2 stage of clinical testing. These arrangements
may place the development of our drug candidates outside our control, may require us to relinquish
important rights or may otherwise be on terms unfavorable to us.
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We may be unable to locate and enter into favorable agreements with third parties, which could
delay or impair our ability to develop and commercialize our drug candidates and could increase our
costs of development and commercialization. Dependence on collaborative arrangements or strategic
alliances will subject us to a number of risks, including the risk that:
| 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; | ||
| 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. |
We have no manufacturing capacity and will rely on third party manufacturers for the late stage
development and commercialization of any drugs or devices we may develop or sell.
We do not currently operate manufacturing facilities for clinical or commercial production of
our drug candidates under development or our currently marketed ALIGN products. We currently lack
the resources or the capacity to manufacture any of our products on a clinical or commercial scale.
We depend upon a third party, Sinclair, to manufacture the commercial products sold by our ALIGN
subsidiary and we cannot rely upon Sinclair to continue to supply the products. We anticipate
future reliance on a limited number of third party manufacturers until we are able, or decide to,
expand our operations to include manufacturing capacities. Any performance failure on the part of
manufacturers could delay late stage clinical development or regulatory approval of our drug, the
commercialization of our drugs or our ability to sell our commercial products, producing additional
losses and depriving us of potential product revenues.
If the FDA or other regulatory agencies approve any of our drug candidates for commercial
sale, or if we significantly expand our clinical trials, we will need to manufacture them in larger
quantities and will be required to secure alternative third-party suppliers to our current
suppliers. To date, our drug candidates have been manufactured in small quantities for preclinical
testing and clinical trials and we may not be able to successfully increase the manufacturing
capacity, whether in collaboration with our current or future third-party manufacturers or on our
own, for any of our drug candidates in a timely or economic manner, or at all. Significant scale-up
of manufacturing may require additional validation studies, which the FDA and other regulatory
bodies must review and approve. If we are unable to successfully increase the manufacturing
capacity for a drug candidate whether for late stage clinical trials or for commercial sale or are
unable to secure alternative third-party suppliers to our current suppliers, the drug development,
regulatory approval or commercial launch of any related drugs may be delayed or blocked or there
may be a shortage in supply. Even if any third party manufacturer makes improvements in the
manufacturing process for our drug candidates, we may not own, or may have to share, the
intellectual property rights to such innovation.
As we evolve from a company primarily involved in discovery and development to one also involved in
the commercialization of drugs and devices, we may encounter difficulties in managing our growth
and expanding our operations successfully.
In order to execute our business strategy, we will need to expand our development, control and
regulatory capabilities and develop financial, manufacturing, marketing and sales capabilities or
contract with third parties to provide these capabilities for us. If our operations expand, we
expect that we will need to manage additional relationships with various collaborative partners,
suppliers and other third parties. Our
ability to manage our operations and any growth will require us to make appropriate changes
and upgrades, as necessary, to our operational, financial and management controls, reporting
systems and procedures wherever we may operate. Any inability to manage growth could delay the
execution of our business plan or disrupt our operations.
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The failure to attract and retain skilled personnel and key relationships could impair our drug
development and commercialization efforts.
We are highly dependent on our senior management and key scientific, technical and sales and
marketing personnel. Competition for these types of personnel is intense. The loss of the services
of any member of our senior management, scientific, technical or sales or marketing staff may
significantly delay or prevent the achievement of drug development and other business objectives
and could have a material adverse effect on our business, operating results and financial
condition. We also rely on consultants and advisors to assist us in formulating our strategy. All
of our consultants and advisors are either self-employed or employed by other organizations, and
they may have conflicts of interest or other commitments, such as consulting or advisory contracts
with other organizations, that may affect their ability to contribute to us. The success of the
commercialization of the ALIGN products depends, in large part, on our continued ability to develop
and maintain important relationships with distributors and research and medical institutions.
Failure to do that could have a material adverse effect on our ability to commercialize the ALIGN
products.
We intend to expand and develop new drug candidates. We will need to hire additional employees
in order to continue our clinical trials and market our drug candidates and medical devices. This
strategy will require us to recruit additional executive management and scientific and technical
personnel. There is currently intense competition for skilled executives and employees with
relevant scientific and technical expertise, and this competition is likely to continue. The
inability to attract and retain sufficient scientific, technical and managerial personnel could
limit or delay our product development efforts, which would adversely affect the development of our
drug candidates and commercialization of our potential drugs and growth of our business.
Our drug candidates are subject to extensive regulation, which can be costly and time-consuming,
and we may not obtain approvals for the commercialization of any of our drug candidates.
The clinical development, manufacturing, selling and marketing of our drug candidates are
subject to extensive regulation by the FDA and other regulatory authorities in the United States,
the European Union and elsewhere. These regulations also vary in important, meaningful ways from
country to country. We are not permitted to market a potential drug in the United States until we
receive approval of an NDA from the FDA. We have not received an NDA approval from the FDA for any
of our drug candidates.
Obtaining an NDA approval is expensive and is a complex, lengthy and uncertain process. The
FDA approval process for a new drug involves completion of preclinical studies and the submission
of the results of these studies to the FDA, together with proposed clinical protocols,
manufacturing information, analytical data and other information in an Investigational New Drug, or
IND, which must become effective before human clinical trials may begin. Clinical development
typically involves three phases of study: Phase 1, 2 and 3. The most significant costs associated
with clinical development are the pivotal or suitable for registration late Phase 2 or Phase 3
clinical trials as they tend to be the longest and largest studies conducted during the drug
development process. After completion of clinical trials, an NDA may be submitted to the FDA. In
responding to an NDA, the FDA may refuse to file the application, or if accepted for filing, the
FDA may grant marketing approval, request additional information or deny the application if it
determines that the application does not provide an adequate basis for approval. In addition,
failure to comply with the FDA and other applicable foreign and U.S. regulatory requirements may
subject us to administrative or judicially imposed sanctions. These include warning letters, civil
and criminal penalties, injunctions, product seizure or detention, product recalls, total or
partial suspension of production and refusal to approve either pending NDAs, or supplements to
approved NDAs.
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Despite the substantial time and expense invested in preparation and submission of an NDA or
equivalents in other jurisdictions, regulatory approval is never guaranteed. The FDA and other
regulatory authorities in the United States, the European Union and elsewhere exercise substantial
discretion in the drug approval process. The number, size and design of preclinical studies and
clinical trials that will be required for FDA or other regulatory approval will vary depending on
the drug candidate, the disease or condition for which the drug candidate is intended to be used
and the regulations and guidance documents applicable to any particular drug candidate. The FDA or
other regulators can delay, limit or deny approval of a drug candidate for many reasons, including,
but not limited to:
| 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. |
With regard to the ALIGN products, and following regulatory approval of any of our drug candidates,
we are subject to ongoing regulatory obligations and restrictions, which may result in significant
expense and limit our ability to commercialize our potential products.
With regard to our ALIGN products and our drug candidates, if any, approved by the FDA or by
another regulatory authority, we are held to extensive regulatory requirements over product
manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion and
record keeping. Regulatory approvals may also be subject to significant limitations on the
indicated uses or marketing of the drug candidates. Potentially costly follow-up or post-marketing
clinical studies may be required as a condition of approval to further substantiate safety or
efficacy, or to investigate specific issues of interest to the regulatory authority. Previously
unknown problems with the product or drug candidate, including adverse events of unanticipated
severity or frequency, may result in restrictions on the marketing of the drug or device, and could
include withdrawal of the drug or device from the market.
In addition, the law or regulatory policies governing pharmaceuticals may change. New
statutory requirements may be enacted or additional regulations may be enacted that could prevent
or delay regulatory approval of our drug candidates. We cannot predict the likelihood, nature or
extent of adverse government regulation that may arise from future legislation or administrative
action, either in the United States or elsewhere. If we are not able to maintain regulatory
compliance, we might not be permitted to market our drugs and our business could suffer.
Our applications for regulatory approval could be delayed or denied due to problems with studies
conducted before we in-licensed the rights to some of our product candidates.
We currently license some of the compounds and drug candidates used in our research programs
from third parties. These include sapacitabine which was licensed from Daiichi Sankyo. Our present
research involving these compounds relies upon previous research conducted by third parties over
whom we had no control and before we in-licensed the drug candidates. In order to receive
regulatory approval of a drug candidate, we must present all relevant data and information obtained
during our research and development, including research conducted prior to our licensure of the
drug candidate. Although we are not currently aware of any such problems, any problems that emerge
with preclinical research and testing conducted prior to our in-licensing may affect future results
or our ability to document prior research and to conduct clinical trials, which could delay, limit
or prevent regulatory approval for our drug candidates.
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We face intense competition and our competitors may develop drugs that are less expensive, safer,
or more effective than our drug candidates.
A large number of drug candidates are in development for the treatment of leukemia, lung
cancer, lymphomas and nasopharyngeal cancer. Several pharmaceutical and biotechnology companies
have nucleoside analogs or other products on the market or in clinical trials which may be
competitive to sapacitabine in both hematological and oncology indications. These include Celgene,
Cephalon, Eisai, Johnson & Johnson, Eli Lilly, Genzyme, GlaxoSmithKline, Hospira, Onconova,
Pfizer, Seattle Genetics and Sunesis. There are two other orally available CDK inhibitors in
Phase 2 clinical trials. PD-0332991 (Pfizer/Onyx) and PHA-848125 (Nerviano Medical Sciences) target
different subsets of kinase enzymes and have a different mechanism of action from seliciclib. We
believe that seliciclib is currently the most advanced orally available CDK-specific agent in Phase
2 clinical trials but that there are a number of companies, including AstraZeneca, Astex
Pharmaceuticals, Bayer-Schering, Eisai, Merck, Nerviano Medical Sciences, Pfizer, Piramal Life
Sciences, and Roche that are developing CDK inhibitors in early stage clinical trials in cancer
patients. Although Aventis, a predecessor of Sanofi-Aventis, had previously announced that it has
ceased Phase 2 development of alvocidib or flavopiridol, a CDK inhibitor, we believe that the
National Cancer Institutes Cancer Therapy Evaluation Program, or CTEP, is continuing to enroll
patients in a CTEP sponsored trial in patients with chronic leukemia. A number of companies are
pursuing discovery and research activities in each of the other areas that are the subject of our
research and drug development programs. We believe that Amgen, Astex Pharmaceuticals, AstraZeneca,
Entremed, Merck, jointly with Vertex, Nerviano Medical Sciences, Pfizer, Rigel, Sunesis and
Takeda-Millennium have commenced Phase 1, Phase 2, or Phase 3 clinical trials of Aurora kinase
inhibitors in patients with advanced cancers. Several companies have reported selection of Aurora
kinase inhibitor candidates for development and may have started or are expected to start clinical
trials within the next twelve months. We believe that Boehringer Ingelheim, GlaxoSmithKline, Merck,
Nerviano Medical Sciences, Takeda-Millennium and Tekmira Pharmaceuticals Corporation have commenced
Phase 1 or Phase 2 clinical trials with Plk inhibitor candidates for oncology indications. For our
ALIGN products, we believe that Beiersdorf, Daiichi Sankyo, Eisai, Johnson & Johnson, MPM Medical
and other companies market products for radiation dermatitis and xerostomia.
Our competitors, either alone or together with collaborators, may have substantially greater
financial resources and research and development staff. Our competitors may also have more
experience:
| developing drug candidates; | ||
| conducting preclinical and clinical trials; | ||
| obtaining regulatory approvals; and | ||
| commercializing product candidates. |
Our competitors may succeed in obtaining patent protection and regulatory approval and may
market drugs before we do. If our competitors market drugs that are less expensive, safer, more
effective or more convenient to administer than our potential drugs, or that reach the market
sooner than our potential drugs, we may not achieve commercial success. Scientific, clinical or
technical developments by our competitors may render our drug candidates obsolete or
noncompetitive. We anticipate that we will face increased competition in the future as new
companies enter the markets and as scientific developments progress. If our drug candidates obtain
regulatory approvals, but do not compete effectively in the marketplace, our business will suffer.
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The commercial success of the ALIGN products and our drug candidates depends upon their market
acceptance among physicians, patients, healthcare providers and payors and the medical community.
It is necessary that our and our distribution partners products, including Xclair® Cream,
Numoisyn® Liquid and Numoisyn® Lozenges achieve and maintain market acceptance. If our drug
candidates are
approved by the FDA or by another regulatory authority, the resulting drugs, if any, may not
gain market acceptance among physicians, healthcare providers and payors, patients and the medical
community. The degree of market acceptance of any of our approved drugs or devices will depend on a
variety of factors, including:
| 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. |
If our drugs fail to achieve market acceptance, we may not be able to generate significant
revenue and our business would suffer.
If we are unable to compete successfully in our market place, it will harm our business.
There are existing products in the marketplace that compete with our products. Companies may
develop new products that compete with our products. Certain of these competitors and potential
competitors have longer operating histories, substantially greater product development capabilities
and financial, scientific, marketing and sales resources. Competitors and potential competitors may
also develop products that are safer, more effective or have other potential advantages compared to
our products. In addition, research, development and commercialization efforts by others could
render our products obsolete or non-competitive. Certain of our competitors and potential
competitors have broader product offerings and extensive customer bases allowing them to adopt
aggressive pricing policies that would enable them to gain market share. Competitive pressures
could result in price reductions, reduced margins and loss of market share. We could encounter
potential customers that, due to existing relationships with our competitors, are committed to
products offered by those competitors. As a result, those potential customers may not consider
purchasing our products.
There is uncertainty related to coverage, reimbursement and payment by healthcare providers and
payors for the ALIGN products and newly approved drugs, if any. The inability or failure to obtain
or maintain coverage could affect our ability to market the ALIGN products and our future drugs and
decrease our ability to generate revenue.
The availability and levels of coverage and reimbursement of newly approved drugs by
healthcare providers and payors is subject to significant uncertainty. The commercial success of
the ALIGN products and our drug candidates in both the United States and international markets is
substantially dependent on whether third party coverage and reimbursement is available. The United
States Centers for Medicare and Medicaid Services, health maintenance organizations and other third
party payors in the United States, the European Union and other jurisdictions are increasingly
attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of
new drugs and, as a result, they may not cover or provide adequate payment for our potential drugs.
The ALIGN products and our drug candidates may not be considered cost-effective and reimbursement
may not be available to consumers or may not be sufficient to allow the ALIGN products or our drug
candidates to be marketed on a competitive basis.
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In some countries, pricing of prescription drugs is subject to government control. In such
countries, pricing negotiations with governmental authorities can take three to 12 months or longer
following
application to the competent authorities. To obtain reimbursement or pricing approval in such
countries may require conducting an additional clinical trial comparing the cost-effectiveness of
the drug to other alternatives. In the United States, the Medicare Part D drug benefit implemented
in 2006 will limit drug coverage through formularies and other cost and utilization management
programs, while Medicare Part B limits drug payments to a certain percentage of average price or
through restrictive payment policies of least costly alternatives and inherent reasonableness
Our business could be materially harmed if coverage, reimbursement or pricing is unavailable or set
at unsatisfactory levels.
Intellectual property rights and distribution rights for our drug candidate seliciclib and ALIGN
products are licensed from others, and any termination of these licenses could harm our business.
We have in-licensed certain patent rights in connection with the development program of our
drug candidate seliciclib. Pursuant to the CNRS and Institut Curie license under which we license
seliciclib, we are obligated to pay license fees, milestone payments and royalties and provide
regular progress reports. We are also obligated to use reasonable efforts to develop and
commercialize products based on the licensed patents.
We have in-licensed from Sinclair the distribution rights to the ALIGN products. This license
agreement imposes obligations on us and expires in 2015. Although we are currently in compliance
with all of our material obligations under this license, if we were to breach any such obligations,
Sinclair would be permitted to terminate the license. In addition, if we are unable to extend the
term of the license agreement, it would prevent us from distributing the ALIGN products.
Although we are currently in compliance with all of our material obligations under these
licenses, if we were to breach any such obligations our counterparties may be entitled to terminate
the licenses. This would restrict or delay or eliminate our ability to develop and commercialize
the seliciclib or sell the ALIGN products, which could adversely affect our business.
We may be exposed to product liability claims that may damage our reputation and we may not be able
to obtain adequate insurance.
Because we conduct clinical trials in humans, we face the risk that the use of our drug
candidates will result in adverse effects. We believe that we have obtained reasonably adequate
product liability insurance coverage for our trials. We cannot predict, however, the possible harm
or side effects that may result from our clinical trials. Such claims may damage our reputation and
we may not have sufficient resources to pay for any liabilities resulting from a claim excluded
from, or beyond the limit of, our insurance coverage.
As we market commercialized products through our ALIGN subsidiary we are exposed to additional
risks of product liability claims. These risks exist even with respect to drugs and devices that
are approved for commercial sale by the FDA or other regulatory authorities in the United States,
the European Union or elsewhere and manufactured in facilities licensed and regulated by the FDA or
other such regulatory authorities. We have secured limited product liability insurance coverage,
but may not be able to maintain such insurance on acceptable terms with adequate coverage, or at a
reasonable cost. There is also a risk that third parties that we have agreed to indemnify could
incur liability. Even if we were ultimately successful in product liability litigation, the
litigation would consume substantial amounts of our financial and managerial resources and may
exceed insurance coverage creating adverse publicity, all of which would impair our ability to
generate sales of the litigated product as well as our other potential drugs.
We may be required to defend lawsuits or pay damages in connection with the alleged or actual
violation of healthcare statutes such as fraud and abuse laws, and our corporate compliance
programs can never guarantee that we are in compliance with all relevant laws and regulations.
Our commercialization efforts in the United States are subject to various federal and state
laws pertaining to promotion and healthcare fraud and abuse, including federal and state
anti-kickback, fraud and false claims laws. Anti-kickback laws make it illegal for a manufacturer
to offer or pay any remuneration in exchange for, or to induce, the referral of business, including
the purchase of a product. The federal
government has published many regulations relating to the anti-kickback statutes, including
numerous safe harbors or exemptions for certain arrangements. False claims laws prohibit anyone
from knowingly and willingly presenting, or causing to be presented for payment to third-party
payers including Medicare and Medicaid, claims for reimbursed products or services that are false
or fraudulent, claims for items or services not provided as claimed, or claims for medically
unnecessary items or services.
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Our activities relating to the sale and marketing of our products will be subject to scrutiny
under these laws and regulations. It may be difficult to determine whether or not our activities,
comply with these complex legal requirements. Violations are punishable by significant criminal
and/or civil fines and other penalties, as well as the possibility of exclusion of the product from
coverage under governmental healthcare programs, including Medicare and Medicaid. If the government
were to investigate or make allegations against us or any of our employees, or sanction or convict
us or any of our employees, for violations of any of these legal requirements, this could have a
material adverse effect on our business, including our stock price. Our activities could be subject
to challenge for many reasons, including the broad scope and complexity of these laws and
regulations, the difficulties in interpreting and applying these legal requirements, and the high
degree of prosecutorial resources and attention being devoted to the biopharmaceutical industry and
health care fraud by law enforcement authorities. During the last few years, numerous
biopharmaceutical companies have paid multi-million dollar fines and entered into burdensome
settlement agreements for alleged violation of these requirements, and other companies are under
active investigation. Although we have developed and implemented corporate and field compliance
programs as part of our commercialization efforts, we cannot assure you that we or our employees,
directors or agents were, are or will be in compliance with all laws and regulations or that we
will not come under investigation, allegation or sanction.
In addition, we may be required to prepare and report product pricing-related information to
federal and state governmental authorities, such as the Department of Veterans Affairs and under
the Medicaid program. The calculations used to generate the pricing-related information are complex
and require the exercise of judgment. If we fail to accurately and timely report product
pricing-related information or to comply with any of these or any other laws or regulations,
various negative consequences could result, including criminal and/or civil prosecution,
substantial criminal and/or civil penalties, exclusion of the approved product from coverage under
governmental healthcare programs including Medicare and Medicaid, costly litigation and restatement
of our financial statements. In addition, our efforts to comply with this wide range of laws and
regulations are, and will continue to be, time-consuming and expensive.
If our supplier upon whom we rely fails to produce on a timely basis the finished goods in the
volumes that we require or fails to meet quality standards and maintain necessary licensure from
regulatory authorities, we may be unable to meet demand for our products, potentially resulting in
lost revenues.
Our licensor and supplier Sinclair contracts with third party manufacturers to supply the
finished goods to us to meet our needs. If any of Sinclairs third party manufacturers service
providers do not meet our or our licensors requirements for quality, quantity or timeliness, or do
not achieve and maintain compliance with all applicable regulations, demand for our products or our
ability to continue supplying such products could substantially decline. As the third party
manufacturers are the sole supplier of the products any delays may impact our sales.
In all the countries where we sell or may sell our products, governmental regulations exist to
define standards for manufacturing, packaging, labeling and storing. All of our suppliers of raw
materials and contract manufacturers must comply with these regulations. Failure to do so could
result in supply interruptions. In the United States, the FDA requires that all suppliers of
pharmaceutical bulk material and all manufacturers of pharmaceuticals for sale in or from the
United States achieve and maintain compliance with the FDAs Current Good Manufacturing Practice or
cGMP regulations and guidelines. Failure of our third-party manufacturers to comply with applicable
regulations could result in sanctions being imposed on them or us, including fines, injunctions,
civil penalties, disgorgement, suspension or withdrawal of approvals, license revocation, seizures
or recalls of products, operating restrictions and criminal
prosecutions, any of which could significantly and adversely affect supplies of our products.
In addition, before any product batch produced by our manufacturers can be shipped, it must conform
to release specifications pre-approved by regulators for the content of the pharmaceutical product.
If the operations of one or more of our manufacturers were to become unavailable for any reason,
any required FDA review and approval of the operations of an alternative supplier could cause a
delay in the manufacture of our products.
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Our customer base is highly concentrated.
Our principal customers are a small number of wholesale drug distributors. These customers
comprise a significant part of the distribution network for pharmaceutical products in the United
States. Three large wholesale distributors, AmerisourceBergen Corporation, Cardinal Health, Inc.
and McKesson Corporation, control a significant share of the market in the United States. Our
ability to distribute any product, including Xclair® Cream, Numoisyn® Liquid and Numoisyn® Lozenges
and to recognize revenues on a timely basis is substantially dependent on our ability to maintain
commercially reasonable agreements with each of these wholesale distributors and the extent to
which these distributors, over whom we have no control, comply with such agreements. Our agreements
with wholesaler distributors may contain terms that are not favorable, given our relative lack of
market leverage as a company with only three approved products or other factors, which could
adversely affect our commercialization of Xclair® Cream, Numoisyn® Liquid and Numoisyn® Lozenges.
The loss of any of these customers could materially and adversely affect our ability to distribute
our products, resulting in a negative impact on our operations and financial condition.
We may be unable to accurately estimate demand and monitor wholesaler inventory of Xclair® Cream,
Numoisyn® Liquid or Numoisyn® Lozenges. Although we attempt to monitor wholesaler inventory of
Xclair® Cream, Numoisyn® Liquid or Numoisyn® Lozenges, we also rely on third party information,
which is inherently uncertain and may not be accurate, to assist us in monitoring estimated
inventory levels and prescription trends. Inaccurate estimates of the demand and inventory levels
of the product may cause our revenues to fluctuate significantly from quarter to quarter and may
cause our operating results for a particular quarter to be below expectations.
Inventory levels of Xclair® Cream, Numoisyn® Liquid or Numoisyn® Lozenges held by wholesalers
can also cause our operating results to fluctuate unexpectedly. For the three months ended
September 30, 2010 and 2011, approximately 92% and 87%, respectively, of our product sales in the
United States were to three wholesalers, Cardinal Health, Inc., McKesson Corporation and
AmerisourceBergen. For the nine months ended September 30, 2010 and 2011, approximately 88% and
89%, respectively, of our product sales were to the three wholesalers. Inventory levels held by
those wholesalers can cause our operating results to fluctuate unexpectedly if our sales to
wholesalers do not match customer demand. We have entered into inventory management agreements with
these U.S. wholesalers under which they provide us with data regarding inventory levels at these
wholesalers. However, these wholesalers may not be completely effective in matching inventory
levels to customer demand, as they make estimates to determine customer demand. In addition,
inventory is held at retail pharmacies and other non-wholesaler locations, for which we have no
inventory management agreements and have no control in respect to their buying patterns. Also, the
non-retail sector in the United States, which includes government institutions and large health
maintenance organizations, tends to be less consistent in terms of buying patterns, and often
causes quarter-over-quarter fluctuations in inventory and ordering patterns. We attempt to monitor
inventory of Xclair®, Numoisyn® Liquid or Numoisyn® Lozenges in the United States through the use
of internal sales forecasts and the expiration dates of product shipped, among other factors.
The commercialization of our products is substantially dependent on our ability to develop
effective sales and marketing capabilities.
Our successful commercialization of Xclair® Cream, Numoisyn® Liquid and Numoisyn® Lozenges in
the United States will depend on our ability to establish and maintain effective sales and
marketing initiatives in the United States. Although we launched the ALIGN products with a small
specialty oncology sales force, we now sell and market our products via unique sales and marketing
strategies in order to reduce costs. We contracted, trained and deployed additional telemarketing
personnel to call on specialists
who prescribe ALIGN products. We also utilize mailings, print advertising, sampling, trade
show attendance and other unique marketing programs to reach our customer base. We may increase
or decrease the size of our telemarketing sales force in the future, depending on many factors,
including the effectiveness of the sales force, the level of market acceptance of Xclair® Cream,
Numoisyn® Liquid and Numoisyn® Lozenges and the results of our clinical trials. Prior to our
launches of these products, we had never sold or marketed any products.
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For our product candidates currently under development, our strategy is to develop compounds
through the Phase 2 stage of clinical testing and market or co-promote certain of our drugs on our
own. We have limited sales, marketing or distribution capabilities. We will depend primarily on
strategic alliances with third parties, which have established distribution systems and sales
forces, to commercialize our drugs. To the extent that we are unsuccessful in commercializing any
drugs or devices ourselves or through a strategic alliance, product revenues will suffer, we will
incur significant additional losses and our share price will be negatively affected.
Defending against claims relating to improper handling, storage or disposal of hazardous chemical,
radioactive or biological materials could be time consuming and expensive.
Our research and development involves the controlled use of hazardous materials, including
chemicals, radioactive and biological materials such as chemical solvents, phosphorus and bacteria.
Our operations produce hazardous waste products. We cannot eliminate the risk of accidental
contamination or discharge and any resultant injury from those materials. Various laws and
regulations govern the use, manufacture, storage, handling and disposal of hazardous materials. We
may be sued for any injury or contamination that results from our use or the use by third parties
of these materials. Compliance with environmental laws and regulations may be expensive, and
current or future environmental regulations may impair our research, development and production
efforts.
Risks Related to Our Business and Financial Condition
The current economic conditions and financial market turmoil could adversely affect our business
and results of operations.
Economic conditions remain difficult with the continuing uncertainty in the global credit
markets, the European Union, the financial services industry and the United States capital markets
and with the United States economy as a whole experiencing a period of substantial turmoil and
uncertainty characterized by unprecedented intervention by the United States federal government and
the failure, bankruptcy, or sale of various financial and other institutions. We believe the
current economic conditions and financial market turmoil could adversely affect our operations,
business and prospects, as well as our ability to obtain funds. If these circumstances persist or
continue to worsen, our future operating results could be adversely affected, particularly relative
to our current expectations.
We are at an early stage of development as a company and we do not have, and may never have, any
products that generate significant revenues.
We are at an early stage of development as a company and have a limited operating history on
which to evaluate our business and prospects. While we have earned modest product revenues from the
ALIGN business acquired in October 2007, since beginning operations in 1996, we have not generated
any product revenues from our product candidates currently in development. We cannot guarantee that
any of our product candidates currently in development will ever become marketable products and we
do not anticipate material revenues from the ALIGN products in the foreseeable future. We must
demonstrate that our drug candidates satisfy rigorous standards of safety and efficacy for their
intended uses before the FDA, and other regulatory authorities in the United States, the European
Union and elsewhere. Significant additional research, preclinical testing and clinical testing is
required before we can file applications with the FDA or other regulatory authorities for premarket
approval of our drug candidates. In addition, to compete effectively, our drugs must be easy to
administer, cost-effective and economical to manufacture on a commercial scale. We may not achieve
any of these objectives. Sapacitabine, our most advanced drug
candidates for the treatment of cancer, is currently in Phase 3 for AML and Phase 2 for MDS.
Seliciclib is currently in Phase 2 clinical trials. A combination trial of sapacitabine and
seliciclib is currently in a Phase 1 clinical trial. We cannot be certain that the clinical
development of these or any other drug candidates in preclinical testing or clinical development
will be successful, that we will receive the regulatory approvals required to commercialize them or
that any of our other research and drug discovery programs will yield a drug candidate suitable for
investigation through clinical trials. Our commercial revenues from our product candidates
currently in development, if any, will be derived from sales of drugs that will not become
marketable for several years, if at all.
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We have a history of operating losses and we may never become profitable. Our stock is a highly
speculative investment.
We have incurred operating losses in each year since beginning operations in 1996 due to costs
incurred in connection with our research and development activities and selling, general and
administrative costs associated with our operations, and we may never achieve profitability. As of
December 31, 2010 and September 30, 2011, our accumulated deficit was $241.8 million and $253.4
million, respectively. Our net loss for the nine months ended September 30, 2010 and 2011 was
$12.8 million and $11.6 million, respectively. Our net loss applicable to common stockholders from
inception through September 30, 2011 was $294.9 million. Our drug candidates are in the mid-stages
of clinical testing and we must conduct significant additional clinical trials before we can seek
the regulatory approvals necessary to begin commercial sales of our drugs. We expect to incur
continued losses for several years, as we continue our research and development of our drug
candidates, seek regulatory approvals, commercialize any approved drugs and market and promote the
ALIGN products: Xclair® Cream, Numoisyn® Liquid and Numoisyn® Lozenges. If our drug candidates are
unsuccessful in clinical trials or we are unable to obtain regulatory approvals, or if our drugs
are unsuccessful in the market, we will not be profitable. If we fail to become and remain
profitable, or if we are unable to fund our continuing losses, particularly in light of the current
economic conditions, you could lose all or part of your investment.
Capital markets are currently experiencing a period of disruption and instability, which has had
and could continue to have a negative impact on the availability and cost of capital.
The general disruption in the United States capital markets has impacted the broader worldwide
financial and credit markets and reduced the availability of debt and equity capital for the market
as a whole. These global conditions could persist for a prolonged period of time or worsen in the
future. Our ability to access the capital markets may be restricted at a time when we would like,
or need, to access those markets, which could have an impact on our flexibility to react to
changing economic and business conditions. The resulting lack of available credit, lack of
confidence in the financial sector, increased volatility in the financial markets could materially
and adversely affect the cost of debt financing and the proceeds of equity financing may be
materially adversely impacted by these market conditions.
If we fail to comply with the continued listing requirements of the NASDAQ Global Market our common
stock price may be delisted and the price of our common stock and our ability to access the capital
markets could be negatively impacted.
Our common stock is currently listed for trading on the NASDAQ Global Market. We must satisfy
NASDAQs continued listing requirements, including among other things, a minimum stockholders
equity of $10.0 million and a minimum bid price for our common stock of $1.00 per share, or risk
delisting, which would have a material adverse effect on our business. A delisting of our common
stock from the NASDAQ Global Market could materially reduce the liquidity of our common stock and
result in a corresponding material reduction in the price of our common stock. In addition,
delisting could harm our ability to raise capital through alternative financing sources on terms
acceptable to us, or at all, and may result in the potential loss of confidence by investors,
suppliers, customers and employees and fewer business development opportunities. During 2009,
Cyclacel received notification from the NASDAQ Stock Market that the Company was not in
compliance with the minimum $10 million stockholders equity requirement for continued listing set
forth in NASDAQ Marketplace Rule 5450(b)(1)(A). On January 27, 2010,
NASDAQ notified the Company that it regained compliance with the minimum $50 million market value
of listed securities requirement and that it currently complies with all other applicable standards
for continued listing on The NASDAQ Global Market. Accordingly, the Companys shares of common and
preferred stock will continue to trade on The NASDAQ Global Market. In September 2011, Cyclacel
received a NASDAQ Staff Deficiency Letter indicating that it was not in compliance with the minimum
bid price requirement for continued listing on the NASDAQ exchange because the bid price for the
common stock had closed under $1.00 for 30 consecutive business days. We may achieve compliance if,
at any time before March 14, 2012, the bid price of our stock closes at $1.00 per share or more for
a minimum of 10 consecutive business days. If we are not able to comply with the bid price
requirement by March 14, 2012, or in subsequent 180 day period as allowed by NASDAQ, the NASDAQ
staff may begin the process to have our securities delisted.
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Raising additional capital in the future may not be available to us on reasonable terms, if at all,
when or as we require additional funding. If we issue additional shares of our common stock or
other securities that may be convertible into, or exercisable or exchangeable for, our common
stock, our existing stockholders would experience further dilution. If we fail to obtain additional
funding, we may be unable to complete the development and commercialization of our lead drug
candidate, sapacitabine, or continue to fund our research and development programs.
We have funded all of our operations and capital expenditures with proceeds from the issuance
of public equity securities, private placements of our securities, interest on investments,
licensing revenue, government grants, research and development tax credits and product revenue. In
order to conduct the lengthy and expensive research, preclinical testing and clinical trials
necessary to complete the development and marketing of our drug candidates, we will require
substantial additional funds. Based on our current operating plans of focusing on the advancement
of sapacitabine, we expect our existing resources to be sufficient to fund our planned operations
for at least the next twelve months. To meet our long-term financing requirements, we may raise
funds through public or private equity offerings, debt financings or strategic alliances. Raising
additional funds by issuing equity or convertible debt securities may cause our stockholders to
experience substantial dilution in their ownership interests and new investors may have rights
superior to the rights of our other stockholders. Raising additional funds through debt financing,
if available, may involve covenants that restrict our business activities and options. To the
extent that we raise additional funds through collaborations and licensing arrangements, we may
have to relinquish valuable rights to our drug discovery and other technologies, research programs
or drug candidates, or grant licenses on terms that may not be favorable to us. Additional funding
may not be available to us on favorable terms, or at all, particularly in light of the current
economic conditions. If we are unable to obtain additional funds, we may be forced to delay or
terminate our current clinical trials and the development and marketing of our drug candidates
including sapacitabine.
To the extent we elect to fund the development of a drug candidate or the commercialization of a
drug at our expense, we will need substantial additional funding.
We plan to market drugs on our own, with or without a partner, that can be effectively
commercialized and sold in concentrated markets that do not require a large sales force to be
competitive. To achieve this goal, we will need to establish our own specialized sales force,
marketing organization and supporting distribution capabilities. The development and
commercialization of our drug candidates is very expensive, including our Phase 3 clinical trials
for sapacitabine. To the extent we elect to fund the full development of a drug candidate or the
commercialization of a drug at our expense, we will need to raise substantial additional funding
to:
| 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. |
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Our future funding requirements will depend on many factors, including:
| 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. |
If we are not able to secure additional funding when needed, especially in light of the
current economic conditions and financial market turmoil, we may have to delay, reduce the scope of
or eliminate one or more of our clinical trials or research and development programs or future
commercialization efforts.
Any future workforce and expense reductions may have an adverse impact on our internal programs,
strategic plans, and our ability to hire and retain key personnel, and may also be distracting to
our management.
Further workforce and expense reductions in addition to those carried out in September 2008
and June 2009 could result in significant delays in implementing our strategic plans. In addition,
employees, whether or not directly affected by such reduction, may seek future employment with our
business partners or competitors. Although our employees are required to sign a confidentiality
agreement at the time of hire, the confidential nature of certain proprietary information may not
be maintained in the course of any such future employment. In addition, any additional workforce
reductions or restructurings would be expected to involve significant expense as a result of
contractual terms in certain of our existing agreements, including potential severance obligations
as well as any payments that may, under certain circumstances, be required under our agreement with
the Scottish Enterprise. Further, we believe that our future success will depend in large part upon
our ability to attract and retain highly skilled personnel. We may have difficulty retaining and
attracting such personnel as a result of a perceived risk of future workforce and expense
reductions. Finally, the implementation of expense reduction programs may result in the diversion
of the time and attention of our executive management team and other key employees, which could
adversely affect our business.
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Budget constraints resulting from our restructuring plan may negatively impact our research and
development, forcing us to delay our efforts to develop certain product candidates in favor of
developing others, which may prevent us from commercializing our product candidates as quickly as
possible.
Research and development is an expensive process. As part of our restructuring plan, we have
decided to focus our clinical development priorities on sapacitabine, while still possibly
continuing to progress additional programs pending the availability of clinical data and the
availability of funds, at which time we will determine the feasibility of pursuing, if at all,
further advanced development of seliciclib, CYC116 or additional programs. Because we have had to
prioritize our development candidates as a result of budget constraints, we may not be able to
fully realize the value of our product candidates in a timely manner, if at all.
We are exposed to risks related to foreign currency exchange rates.
Some of our costs and expenses are denominated in foreign currencies. Most of our foreign
expenses are associated with our research and development operations of our United Kingdom-based
wholly-owned subsidiary. When the United States dollar weakens against the British pound or other
foreign currency, the United States dollar value of the foreign currency denominated expense
increases, and when the United States dollar strengthens against the British pound or other foreign
currency, the United States dollar value of the foreign currency denominated expense decreases.
Consequently, changes in exchange rates, and in particular a weakening of the United States dollar,
may adversely affect our results of operations
Risks Related to our Intellectual Property
We may be subject to damages resulting from claims that our employees or we have wrongfully used or
disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at universities or other biotechnology or
pharmaceutical companies, including our competitors or potential competitors. Although no claims
against us are currently pending, we may be subject to claims that these employees or we have
inadvertently or otherwise used or disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend against these claims. If we fail in
defending such claims, in addition to paying monetary damages, we may lose valuable intellectual
property rights or personnel. A loss of key research personnel or their work product could hamper
or prevent our ability to commercialize certain potential drugs, which could severely harm our
business. Even if we are successful in defending against these claims, litigation could result in
substantial costs and be a distraction to management.
If we fail to enforce adequately or defend our intellectual property rights our business may be
harmed.
Our commercial success depends in large part on obtaining and maintaining patent and trade
secret protection for our drug candidates, the methods used to manufacture those drug candidates
and the methods for treating patients using those drug candidates.
Specifically, sapacitabine is covered in granted, composition of matter patents that expire in
2014 in the United States and 2012 outside the United States. Sapacitabine is further protected by
additional granted, composition of matter patents claiming certain, stable crystalline forms of
sapacitabine and their pharmaceutical compositions and therapeutic uses that expire in 2022 and
also patent applications claiming the combination of sapacitabine with decitabine which is being
tested as one of the arms of the SEAMLESS Phase 3 trial . In early development, amorphous
sapacitabine was used. We have used one of the stable, crystalline forms of sapacitabine in nearly
all our Phase 1 and in all of our Phase 2 clinical studies. We have also chosen this form for
commercialization. Additional patents claim certain medical uses and formulations of sapacitabine
which have emerged in our clinical trials. Seliciclib is protected by granted, composition of
matter patents that expire in 2016. Additional patents claim certain medical uses which have
emerged from our research programs.
Failure to obtain, maintain or extend the patents could adversely affect our business. We will
only be able to protect our drug candidates and our technologies from unauthorized use by third
parties to the extent that valid and enforceable patents or trade secrets cover them.
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Our ability to obtain patents is uncertain because legal means afford only limited protections
and may not adequately protect our rights or permit it to gain or keep any competitive advantage.
Some legal principles remain unresolved and the breadth or interpretation of claims allowed in
patents in the United States, the European Union or elsewhere can still be difficult to ascertain
or predict. In addition, the specific content of patents and patent applications that are necessary
to support and interpret patent claims is highly uncertain due to the complex nature of the
relevant legal, scientific and factual issues. Changes in either patent laws or in interpretations
of patent laws in the United States, the European Union or elsewhere may diminish the value of our
intellectual property or narrow the scope of our patent protection. Our existing patents and any
future patents we obtain may not be sufficiently broad to prevent others from practicing our
technologies or from developing competing products and technologies. In addition, we generally do
not control the patent prosecution of subject matter that we license from others and have not
controlled the earlier stages of the patent prosecution. Accordingly, we are unable to exercise the
same degree of control over this intellectual property as we would over our own.
Even if patents are issued regarding our drug candidates or methods of using them, those
patents can be challenged by our competitors who may argue such patents are invalid and/or
unenforceable. Patents also will not protect our drug candidates if competitors devise ways of
making or using these product candidates without legally infringing our patents. The U.S. Federal
Food, Drug and Cosmetic, or FD&C, Act and FDA regulations and policies and equivalents in other
jurisdictions provide incentives to manufacturers to challenge patent validity or create modified,
noninfringing versions of a drug in order to facilitate the approval of abbreviated new drug
applications for generic substitutes. These same types of incentives encourage manufacturers to
submit new drug applications that rely on literature and clinical data not prepared for or by the
drug sponsor.
Proprietary trade secrets and unpatented know-how are also very important to our business. We
rely on trade secrets to protect our technology, especially where we do not believe that patent
protection is appropriate or obtainable. However, trade secrets are difficult to protect. Our
employees, consultants, contractors, outside scientific collaborators and other advisors may
unintentionally or willfully disclose our confidential information to competitors, and
confidentiality agreements may not provide an adequate remedy in the event of unauthorized
disclosure of confidential information. Enforcing a claim that a third party obtained illegally and
is using trade secrets is expensive and time consuming, and the outcome is unpredictable. Moreover,
our competitors may independently develop equivalent knowledge, methods and know-how. Failure to
obtain or maintain trade secret protection could adversely affect our competitive business
position.
Intellectual property rights of third parties may increase our costs or delay or prevent us from
being able to commercialize our drug candidates and/or the ALIGN products.
There is a risk that we are infringing or will infringe the proprietary rights of third
parties because patents and pending applications belonging to third parties exist in the United
States, the European Union and elsewhere in the world in the areas of our research and/or the ALIGN
products. Others might have been the first to make the inventions covered by each of our or our
licensors pending patent applications and issued patents and might have been the first to file
patent applications for these inventions. We are aware of several published patent applications,
and understand that others may exist, that could support claims that, if granted, could cover
various aspects of our developmental programs, including in some cases particular uses of our lead
drug candidate sapacitabine, seliciclib or other therapeutic candidates, or gene sequences and
techniques that we use in the course of our research and development. In addition, we understand
that other applications and patents exist relating to potential uses of sapacitabine and seliciclib
that are not part of our current clinical programs for these compounds. Numerous third-party United
States and foreign issued patents and pending applications exist in the area of kinases, including
CDK, AK and Plk for which
we have research programs. For example, some pending patent applications contain broad claims
that could represent freedom to operate limitations for some of our kinase programs should they be
issued unchanged. Although we intend to continue to monitor these applications, we cannot predict
what claims will ultimately be allowed and if allowed what their scope would be. In addition,
because the patent application process can take several years to complete, there may be currently
pending applications, unknown to us, which may later result in issued patents that cover the
production, manufacture, commercialization or use of our drug candidates. If we wish to use the
technology or compound claimed in issued and unexpired patents owned by others, we will need to
obtain a license from the owner, enter into litigation to challenge the validity of the patents or
incur the risk of litigation in the event that the owner asserts that we infringe its patents. In
one case we have opposed a European patent relating to human aurora kinase and the patent has been
finally revoked (no appeal was filed). We are also aware of a corresponding U.S. patent containing
method of treatment claims for specific cancers using aurora kinase modulators which, if held
valid, could potentially restrict the use of our aurora kinase inhibitors once clinical trials are
completed.
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There has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the pharmaceutical and biotechnology industries. Defending against
third party claims, including litigation in particular, would be costly and time consuming and
would divert managements attention from our business, which could lead to delays in our
development or commercialization efforts. If third parties are successful in their claims, we might
have to pay substantial damages or take other actions that are adverse to our business. As a result
of intellectual property infringement claims, or to avoid potential claims, we might:
| 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. |
Risks Related to Securities Regulations and Investment in Our Securities
Failure to achieve and maintain internal controls is accordance with Sections 302 and 404 of the
Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price.
During March 2011, we identified a deficiency in respect of our internal controls over
financial reporting, specifically our controls over the accounting for cumulative preferred stock
dividends, that constitutes a material weakness as described in the SECs guidance regarding
Managements Report on Internal Control Over Financial Reporting as of December 31, 2010. As a
result of this deficiency, the financial statements included in our Form 10-K for the year ended
December 31, 2009, filed on March 29, 2010, as amended by Amendment No. 1 to our Annual Report on
Form 10-K/A for the year ended December 31, 2009 filed on May 17, 2010 and, as further amended by
Amendment No. 2 to our Annual Report on Form 10-K/A for the year ended December 31, 2009 filed on
May 19, 2010, included errors related to the presentation and disclosure of undeclared cumulative
preferred stock dividends in the consolidated balance sheet and in the statement of stockholders
equity. Unaudited balance sheets for the each of the first three quarters of 2009 and 2010 also
contained errors. In addition, in May 2010, we filed an amendment to our Annual Report on Form 10-K
for the year ended December 31, 2009, to report a restatement of our financial statements and
report a material weakness in our internal control over financial
reporting as of December 31, 2009, specifically related to the operational failure of the
controls in place to ensure the correct computation of net loss per share and presentation of
preferred stock dividends in the consolidated statement of cash flows. In March 2011, our auditors
identified a further error in respect of the accounting, presentation and disclosure of cumulative
undeclared preferred stock dividends, specifically the inclusion of undeclared cumulative preferred
stock dividends as a current liability in its consolidated financial statements, which resulted
from the same material weakness as described above. This has resulted in the restatement of our
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 consolidated statement of
stockholders equity for the year ended December 31, 2009 and selected financial data as of and for
the year ended December 31, 2009.
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If we fail to maintain our internal controls or fail to implement required new or improved
controls, as such control standards are modified, supplemented or amended from time to time, we may
not be able to conclude on an ongoing basis that we have effective internal controls over financial
reporting. Effective internal controls are necessary for us to produce reliable financial reports
and are important in the prevention of financial fraud. If we cannot produce reliable financial
reports or prevent fraud, our business and operating results could be harmed.
We incur increased costs and management resources as a result of being a public company, and we
still may fail to comply with public company obligations.
As a public company, we face and will continue to face increased legal, accounting,
administrative and other costs and expenses as a public company that we would not incur as a
private company. Compliance with the Sarbanes Oxley Act of 2002, as well as other rules of the SEC,
the Public Company Accounting Oversight Board and the NASDAQ Global Market resulted in a
significant initial cost to us as well as an ongoing compliance costs. As a public company, we are
subject to Section 404 of the Sarbanes Oxley Act relating to internal control over financial
reporting. We have completed a formal process to evaluate our internal controls for purposes of
Section 404, and we concluded that as of December 31, 2010, our internal control over financial
reporting was ineffective. As our business grows and changes, there can be no assurances that we
can maintain the effectiveness of our internal controls over financial reporting.
Effective internal controls over financial reporting are necessary for us to provide reliable
financial reports and, together with adequate disclosure controls and procedures, are designed to
prevent fraud. If we cannot provide reliable financial reports or prevent fraud, our operating
results could be harmed. We have completed a formal process to evaluate our internal control over
financial reporting. However, guidance from regulatory authorities in the area of internal controls
continues to evolve and substantial uncertainty exists regarding our on-going ability to comply by
applicable deadlines. Any failure to implement required new or improved controls, or difficulties
encountered in their implementation, could harm our operating results or cause us to fail to meet
our reporting obligations. Ineffective internal controls could also cause investors to lose
confidence in our reported financial information, which could have a negative effect on the trading
price of our common stock.
Our common stock may have a volatile public trading price.
An active public market for our common stock has not developed. Our stock can trade in small
volumes which may make the price of our stock highly volatile. The last reported price of our stock
may not represent the price at which you would be able to buy or sell the stock. The market prices
for securities of companies comparable to us have been highly volatile. Often, these stocks have
experienced significant price and volume fluctuations for reasons that are both related and
unrelated to the operating performance of the individual companies. In addition, the stock market
as a whole and biotechnology and other life science stocks in particular have experienced
significant recent volatility. Like our common stock, these stocks have experienced significant
price and volume fluctuations for reasons unrelated to the operating performance of the individual
companies. In addition, due to our existing stock price, we may not continue to qualify for
continued listing on the NASDAQ Global Market. To maintain listing, we are required to maintain a
minimum closing bid price of $1.00 per share and, among other requirements, to maintain a
minimum stockholders equity value of $10 million. Factors giving rise to this volatility may
include:
| disclosure of actual or potential clinical results with respect to product candidates we are developing; | ||
| regulatory developments in both the United States and abroad; | ||
| developments concerning proprietary rights, including patents and litigation matters; |
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| 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. |
Fluctuations in our operating losses could adversely affect the price of our common stock.
Our operating losses may fluctuate significantly on a quarterly basis. Some of the factors
that may cause our operating losses to fluctuate on a period-to-period basis include the status of
our preclinical and clinical development programs, level of expenses incurred in connection with
our preclinical and clinical development programs, implementation or termination of collaboration,
licensing, manufacturing or other material agreements with third parties, non-recurring revenue or
expenses under any such agreement, and compliance with regulatory requirements. Period-to-period
comparisons of our historical and future financial results may not be meaningful, and investors
should not rely on them as an indication of future performance. Our fluctuating losses may fail to
meet the expectations of securities analysts or investors. Our failure to meet these expectations
may cause the price of our common stock to decline.
If securities or industry analysts do not publish research or reports about us, if they change
their recommendations regarding our stock adversely or if our operating results do not meet their
expectations, our stock price and trading volume could decline.
The trading market for our common stock is influenced by the research and reports that
industry or securities analysts publish about us. If one or more of these analysts cease coverage
of us or fail to regularly publish reports on us, we could lose visibility in the financial
markets, which in turn could cause our stock price or trading volume to decline. Moreover, if one
or more of the analysts who cover us downgrade our stock or if our operating results do not meet
their expectations, our stock price could decline.
Anti-takeover provisions in our charter documents and provisions of Delaware law may make an
acquisition more difficult and could result in the entrenchment of management.
We are incorporated in Delaware. Anti-takeover provisions of Delaware law and our amended and
restated certificate of incorporation and amended and restated bylaws may make a change in control
or efforts to remove management more difficult. Also, under Delaware law, our Board of Directors
may adopt additional anti-takeover measures.
We have the authority to issue up to 5 million shares of preferred stock and to determine the
terms of those shares of stock without any further action by our stockholders. If the Board of
Directors exercises this power to issue preferred stock, it could be more difficult for a third
party to acquire a majority of our outstanding voting stock and vote the stock they acquire to
remove management or directors.
Our amended and restated certificate of incorporation and amended and restated bylaws also
provides staggered terms for the members of our Board of Directors. Under Section 141 of the
Delaware General
Corporation Law, our directors may be removed by stockholders only for cause and only by vote
of the holders of a majority of voting shares then outstanding. These provisions may prevent
stockholders from replacing the entire board in a single proxy contest, making it more difficult
for a third party to acquire control of us without the consent of our Board of Directors. These
provisions could also delay the removal of management by the Board of Directors with or without
cause. In addition, our directors may only be removed for cause and amended and restated bylaws
limit the ability our stockholders to call special meetings of stockholders.
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Under Section 203 of the Delaware General Corporation Law, a corporation may not engage in a
business combination with any holder of 15% or more of its capital stock until the holder has held
the stock for three years unless, among other possibilities, the Board of Directors approves the
transaction. Our Board of Directors could use this provision to prevent changes in management. The
existence of the foregoing provisions could limit the price that investors might be willing to pay
in the future for shares of our common stock.
We have the authority to issue up to 5 million shares of preferred stock and to determine the terms
of those shares of stock without any further action by our stockholders. If the Board of Directors
exercises this power to issue preferred stock, it could be more difficult for a third party to
acquire a majority of our outstanding voting stock and vote the stock they acquire to remove
management or directors.
Our amended and restated certificate of incorporation and amended and restated bylaws also
provides staggered terms for the members of our Board of Directors. Under Section 141 of the
Delaware General Corporation Law, our directors may be removed by stockholders only for cause and
only by vote of the holders of a majority of voting shares then outstanding. These provisions may
prevent stockholders from replacing the entire board in a single proxy contest, making it more
difficult for a third party to acquire control of us without the consent of our Board of Directors.
These provisions could also delay the removal of management by the Board of Directors with or
without cause. In addition, our directors may only be removed for cause and amended and restated
bylaws limit the ability our stockholders to call special meetings of stockholders.
Under Section 203 of the Delaware General Corporation Law, a corporation may not engage in a
business combination with any holder of 15% or more of its capital stock until the holder has held
the stock for three years unless, among other possibilities, the Board of Directors approves the
transaction. Our Board of Directors could use this provision to prevent changes in management. The
existence of the foregoing provisions could limit the price that investors might be willing to pay
in the future for shares of our common stock.
Certain severance-related agreements in our executive employment agreements may make an acquisition
more difficult and could result in the entrenchment of management.
In March 2008 (as subsequently amended, most recently as of January 1, 2011), we entered into
employment agreements with our President and Chief Executive Officer and our Executive Vice
President, Finance, Chief Financial Officer and Chief Operating Officer, which contain severance
arrangements in the event that such executives employment is terminated without cause or as a
result of a change of control (as each such term is defined in each agreement). The financial
obligations triggered by these provisions may prevent a business combination or acquisition that
would be attractive to stockholders and could limit the price that investors would be willing to
pay in the future for our stock.
In the event of an acquisition of our common stock, we cannot assure our common stockholders that
we will be able to negotiate terms that would provide for a price equivalent to, or more favorable
than, the price at which our shares of common stock may be trading at such time.
We may not effect a consolidation or merger with another entity without the vote or consent of
the holders of at least a majority of the shares of our preferred stock (in addition to the
approval of our common stockholders), unless the preferred stock that remains outstanding and its
rights, privileges and preferences
are unaffected or are converted into or exchanged for preferred stock of the surviving entity
having rights, preferences and limitations substantially similar, but no less favorable, to our
convertible preferred stock.
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In addition, in the event a third party seeks to acquire our company or acquire control of our
company by way of a merger, but the terms of such offer do not provide for our preferred stock to
remain outstanding or be converted into or exchanged for preferred stock of the surviving entity
having rights, preferences and limitations substantially similar, but no less favorable, to our
preferred stock, the terms of the Certificate of Designation of our preferred stock provide for an
adjustment to the conversion ratio of our preferred stock such that, depending on the terms of any
such transaction, preferred stockholders may be entitled, by their terms, to receive up to $10.00
per share in common stock, causing our common stockholders not to receive as favorable a price as
the price at which such shares may be trading at the time of any such transaction. As of September
30, 2011, there were 1,213,142 shares of our preferred stock issued and outstanding. If the
transaction were one in which proceeds were received by the Company for distribution to
stockholders, and the terms of the Certificate of Designation governing the preferred stock were
strictly complied with, approximately $13,344,563 would be paid to the preferred holders before any
distribution to the common stockholders, although the form of transaction could affect how the
holders of preferred stock are treated. In such an event, although such a transaction would be
subject to the approval of our holders of common stock, we cannot assure our common stockholders
that we will be able to negotiate terms that would provide for a price equivalent to, or more
favorable than, the price at which our shares of common stock may be trading at such time. Thus,
the terms of our preferred stock might hamper a third partys acquisition of our company.
Our certificate of incorporation and bylaws and certain provisions of Delaware law may delay or
prevent a change in our management and make it more difficult for a third party to acquire us.
Our amended and restated certificate of incorporation and bylaws contain provisions that could
delay or prevent a change in our Board of Directors and management teams. Some of these provisions:
| 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. |
In addition, because we are incorporated in Delaware, we are governed by the provisions of
Section 203 of the Delaware General Corporation Law, which limits the ability of large stockholders
to complete a business combination with, or acquisition of, us. These provisions may prevent a
business combination or acquisition that would be attractive to stockholders and could limit the
price that investors would be willing to pay in the future for our stock.
These provisions also make it more difficult for our stockholders to replace members of our
Board of Directors. Because our Board of Directors is responsible for appointing the members of our
management team, these provisions could in turn affect any attempt to replace our current
management team. Additionally, these provisions may prevent an acquisition that would be attractive
to stockholders and could limit the price that investors would be willing to pay in the future for
our common stock.
We may have limited ability to pay cash dividends on our preferred stock, and there is no assurance
that future quarterly dividends will be declared.
Delaware law may limit our ability to pay cash dividends on our preferred stock. Under
Delaware law, cash dividends on our preferred stock may only be paid from surplus or, if there is
no surplus, from the corporations net profits for the current or preceding fiscal year. Delaware
law defines surplus as the
amount by which the total assets of a corporation, after subtracting its total liabilities,
exceed the corporations capital, as determined by its Board of Directors.
Since we are not profitable, our ability to pay cash dividends will require the availability
of adequate surplus. Even if adequate surplus is available to pay cash dividends on our preferred
stock, we may not have sufficient cash to pay dividends on the preferred stock or we may choose not
to declare the dividends.
On July 8, 2011, the Board of Directors decided not to declare the quarterly cash dividend on
the preferred stock with respect to the second quarter of 2011 that would have otherwise been
payable on August 1, 2011. In addition, the Board of Directors also did not declare the quarterly
cash dividend with respect to each of the four quarters of fiscal year 2009 and the first, second
and third quarters of 2010.
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We have granted additional rights to our holders of preferred stock with respect to the management
of the Company as a result of having not declared quarterly dividends on our preferred stock for a
total of six quarterly dividend periods.
As a result of having not declared quarterly dividends on our preferred stock for a total of
six quarters, the size of the Companys Board was increased by two members and the holders of the
preferred stock, voting separately as a class, voted on May 24, 2011 and elected two directors to
fill the vacancies created thereby. The directors elected by the holders of the preferred stock
will have the ability to participate in the management of the Company until all accrued but unpaid
dividends have been paid in full.
Our common and convertible preferred stock may experience extreme price and volume fluctuations,
which could lead to costly litigation for the Company and make an investment in the Company less
appealing.
The market price of our common and convertible preferred stock may fluctuate substantially due
to a variety of factors, including:
| 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. |
The market prices of the securities of biotechnology companies, particularly companies like us
without product revenues and earnings, have been highly volatile and are likely to remain highly
volatile in the future. This volatility has often been unrelated to the performance of particular
companies. In the past, companies that experience volatility in the market price of their
securities have often faced securities class action litigation. Moreover, market prices for stocks
of biotechnology-related and technology companies frequently reach levels that bear no relationship
to the performance of these companies. These market prices generally are not sustainable and are
highly volatile. Whether or not meritorious, litigation brought against
us could result in substantial costs, divert our managements attention and resources and harm
our financial condition and results of operations. In addition, due to our stock price from time to
time, we may not continue to qualify for continued listing on the NASDAQ Global Market. Please see
Risk Factor: Our common stock may have a volatile public trading price.
The future sale of our common and preferred stock and future issuances of our common stock upon
conversion of our preferred stock could negatively affect our stock price and cause dilution to
existing holders of our common stock.
If our common or preferred stockholders sell substantial amounts of our stock in the public
market, or the market perceives that such sales may occur, the market price of our common and
preferred stock could fall. For example, we were approached by a preferred stockholder that elected
to convert 123,400 of its shares of preferred stock, which shares were converted into 239,396
shares of common stock in the first quarter of 2010. In addition, 710,271 shares of preferred stock
were converted to 1,416,203 shares of common stock during the second quarter of 2010. If
additional holders of preferred stock elect to convert their shares to shares of common stock at
renegotiated prices, such conversion as well as the sale of substantial amounts of our common or
preferred stock, could cause dilution to existing holders of our common stock, thereby also
negatively affecting the price of our common stock.
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If we exchange the convertible preferred stock for debentures, the exchange will be taxable but we
will not provide any cash to pay any tax liability that any convertible preferred stockholder may
incur.
An exchange of convertible preferred stock for debentures, as well as any dividend make-whole
or interest make-whole payments paid in our common stock, will be taxable events for United States
federal income tax purposes, which may result in tax liability for the holder of convertible
preferred stock without any corresponding receipt of cash by the holder. In addition, the
debentures may be treated as having original issue discount, a portion of which would generally be
required to be included in the holders gross income even though the cash to which such income is
attributable would not be received until maturity or redemption of the debenture. We will not
distribute any cash to the holders of the securities to pay these potential tax liabilities.
If we automatically convert the convertible preferred stock, there is a substantial risk of
fluctuation in the price of our common stock from the date we elect to automatically convert to the
conversion date.
We may automatically convert the convertible preferred stock into common stock if the closing
price of our common stock has exceeded $35.30. There is a risk of fluctuation in the price of our
common stock between the time when we may first elect to automatically convert the preferred and
the automatic conversion date.
We do not intend to pay cash dividends on our common stock in the foreseeable future.
We do not anticipate paying cash dividends on our common stock in the foreseeable future. Any
payment of cash dividends will depend on our financial condition, results of operations, capital
requirements, the outcome of the review of our strategic alternatives and other factors and will be
at the discretion of our Board of Directors. Accordingly, investors will have to rely on capital
appreciation, if any, to earn a return on their investment in our common stock. Furthermore, we may
in the future become subject to contractual restrictions on, or prohibitions against, the payment
of dividends.
The number of shares of common stock which are registered, including the shares to be issued upon
exercise of our outstanding warrants, is significant in relation to our currently outstanding
common stock and could cause downward pressure on the market price for our common stock.
The number of shares of common stock registered for resale, including those shares which are
to be issued upon exercise of our outstanding warrants, is significant in relation to the number of
shares of common stock currently outstanding. If the security holder determines to sell a
substantial number of shares into the market at any given time, there may not be sufficient demand
in the market to purchase the shares without a decline in the market price for our common stock.
Moreover, continuous sales into the market of a
number of shares in excess of the typical trading volume for our common stock, or even the
availability of such a large number of shares, could depress the trading market for our common
stock over an extended period of time.
If persons engage in short sales of our common stock, including sales of shares to be issued upon
exercise of our outstanding warrants, the price of our common stock may decline.
Selling short is a technique used by a stockholder to take advantage of an anticipated decline
in the price of a security. In addition, holders of options and warrants will sometimes sell short
knowing they can, in effect, cover through the exercise of an option or warrant, thus locking in a
profit. A significant number of short sales or a large volume of other sales within a relatively
short period of time can create downward pressure on the market price of a security. Further sales
of common stock issued upon exercise of our outstanding warrants could cause even greater declines
in the price of our common stock due to the number of additional shares available in the market
upon such exercise, which could encourage short sales that could further undermine the value of our
common stock. You could, therefore, experience a decline in the value of your investment as a
result of short sales of our common stock.
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We are exposed to risk related to the marketable securities we may purchase.
We may invest cash not required to meet short term obligations in short term marketable
securities. We may purchase securities in United States government, government-sponsored agencies
and highly rated corporate and asset-backed securities subject to an approved investment policy.
Historically, investment in these securities has been highly liquid and has experienced only very
limited defaults. However, recent volatility in the financial markets has created additional
uncertainty regarding the liquidity and safety of these investments. Although we believe our
marketable securities investments are safe and highly liquid, we cannot guarantee that our
investment portfolio will not be negatively impacted by recent or future market volatility or
credit restrictions.
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds. |
None.
Item 3. | Defaults upon Senior Securities. |
None.
Item 4. | (Removed and Reserved). |
Item 5. | Other Information. |
None.
Item 6. | Exhibits. |
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31.1 | * | Certification of Principal Executive Officer Pursuant to Securities
Exchange Act Rule 13a-14(a) As Adopted Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. |
||
31.2 | * | Certification of Principal Financial Officer Pursuant to Securities
Exchange Act Rule 13a-14(a) As Adopted Pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002. |
||
32.1 | ** | Certification of Principal Executive Officer pursuant to Section
906 of the Sarbanes-Oxley Act of 2002. |
||
32.2 | ** | Certification of Principal Financial Officer pursuant to Section
906 of the Sarbanes-Oxley Act of 2002. |
||
101 | *** | The following materials from Cyclacel Pharmaceuticals, Inc.s
Quarterly Report on Form 10-Q for the quarter ended September 30, 2011,
formatted in XBRL (Extensible Business Reporting Language): (i) the
Condensed Consolidated Statements of Income, (ii) the Condensed
Consolidated Balance Sheets, (iii) the Condensed Consolidated
Statements of Cash Flows, and (iv) Notes to Condensed Consolidated
Financial Statements. |
* | Filed herein. | |
** | Furnished herewith. | |
*** | XBRL (Extensible Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise is not subject to liability under these sections. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned.
CYCLACEL PHARMACEUTICALS, INC. |
||||
Date: November 14, 2011 | By: | /s/ Paul McBarron | ||
Paul McBarron | ||||
Chief Operating Officer, Chief Financial Officer and Executive Vice President, Finance |
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