UNITED
STATES
SECURITIES AND EXCHANGE
COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2006
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-50626
CYCLACEL PHARMACEUTICALS, INC.
(Exact name of Registrant as Specified in Its Charter)
DELAWARE | 91-1707622 | ||
(State
or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
||
150 JOHN F. KENNEDY PARKWAY, SHORT HILLS, NJ | 07078 | ||
(Address of principal executive offices) | (Zip Code) | ||
Registrant’s telephone number, including area code: (973) 847-5955
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 No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition of ‘‘accelerated filer and large accelerated filer’’ as defined in Rule 12b-2 of the Exchange Act (Check one):
Large accelerated filer Accelerated filer Non-accelerated filer
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No
As of November 10, 2006 there were 16,157,953 shares of the registrant’s common stock outstanding.
CYCLACEL PHARMACEUTICALS, INC.
INDEX
Page | ||||||||||||
PART I | FINANCIAL INFORMATION |
|
||||||||||
Item 1. | Financial Statements | 3 |
|
|||||||||
Condensed Consolidated Balance Sheets as of September 30, 2006 (unaudited) and December 31, 2005 | 3 |
|
||||||||||
Condensed Consolidated Statements of Operations for the three months and nine months ended September 30, 2006 and 2005 (unaudited) and the period from August 13, 1996 (inception) to September 30, 2006 (unaudited) | 4 |
|
||||||||||
Condensed Consolidated Statements of Comprehensive Loss for the three months and nine months ended September 30, 2006 and 2005 (unaudited) and the period from August 13, 1996 (inception) to September 30, 2006 (unaudited) | 5 |
|
||||||||||
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2006 and 2005 (unaudited) and the period from August 13, 1996 (inception) to September 30, 2006 (unaudited) | 6 |
|
||||||||||
Notes to Condensed Consolidated Financial Statements (unaudited) | 8 |
|
||||||||||
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 19 |
|
|||||||||
Item 3. | Quantitative and Qualitative Disclosures about Market Risk | 30 |
|
|||||||||
Item 4. | Controls and Procedures | 31 |
|
|||||||||
PART II | OTHER INFORMATION |
|
||||||||||
Item 1. | Legal Proceedings | 32 |
|
|||||||||
Item 1A. | Risk Factors | 32 |
|
|||||||||
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 45 |
|
|||||||||
Item 3. | Defaults Upon Senior Securities | 45 |
|
|||||||||
Item 4. | Submission of Matters to a Vote of Security Holders | 46 |
|
|||||||||
Item 5. | Other Information | 46 |
|
|||||||||
Item 6. | Exhibits | 47 |
|
|||||||||
Signature | 48 |
|
||||||||||
2
PART I. FINANCIAL INFORMATION
CYCLACEL PHARMACEUTICALS,
INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED
BALANCE
SHEETS
As
of September 30, 2006 |
As of December 31, 2005 |
|||||||||||
(Unaudited) $000 |
(Note
1) $000 |
|||||||||||
ASSETS | ||||||||||||
Current assets: |
|
|
||||||||||
Cash and cash equivalents | 49,787 |
|
3,117 |
|
||||||||
Short-term investments | 9,951 |
|
10,690 |
|
||||||||
Prepaid expenses and other current assets | 3,219 |
|
3,219 |
|
||||||||
Total current assets | 62,957 |
|
17,026 |
|
||||||||
Property, plant and equipment (net) | 1,555 |
|
2,045 |
|
||||||||
Deposits and other assets | 259 |
|
— |
|
||||||||
Goodwill | 2,749 |
|
— |
|
||||||||
Total assets | 67,520 |
|
19,071 |
|
||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
||||||||||
Current liabilities: |
|
|
||||||||||
Accounts payable | 1,505 |
|
2,159 |
|
||||||||
Amounts due to Cyclacel Group plc | — |
|
10,467 |
|
||||||||
Accrued liabilities | 2,304 |
|
1,869 |
|
||||||||
Other current liabilities | 278 |
|
128 |
|
||||||||
Derivative liability | 1,389 |
|
— |
|
||||||||
Current portion of other accrued restructuring charges | 879 |
|
— |
|
||||||||
Current portion of equipment financing | 156 |
|
251 |
|
||||||||
Total current liabilities | 6,511 |
|
14,874 |
|
||||||||
Other accrued restructuring charges, net of current | 1,673 |
|
— |
|
||||||||
Equipment financing, net of current | — |
|
78 |
|
||||||||
Total liabilities | 8,184 |
|
14,952 |
|
||||||||
Stockholders’ equity: |
|
|
||||||||||
Preferred Ordinary shares, 0.1p par value; Nil and 21,000,000 shares authorized at September 30, 2006 and December 31, 2005, respectively; Nil and 17,965,835 shares issued and outstanding at September 30, 2006 and December 31, 2005, respectively. Aggregate liquidation preference of $Nil and $210,954,000 ($11.74 per share) at September 30, 2006 and December 31, 2005, respectively | — |
|
30 |
|
||||||||
Ordinary shares, 0.1p par value; Nil and 5,748,428 shares authorized at September 30, 2006 and December 31, 2005, respectively; Nil and 1,871,210 shares issued and outstanding at September 30, 2006 and December 31, 2005, respectively | — |
|
2 |
|
||||||||
Preferred stock, $0.001 par value; 5,000,000 and Nil shares authorized at September 30, 2006 and December 31, 2005, respectively; 2,046,813 and Nil shares issued and outstanding at September 30, 2006 and December 31, 2005, respectively. Aggregate preference in liquidation of $20,673,000 and $Nil at September 30, 2006 and December 31, 2005, respectively | 2 |
|
— |
|
||||||||
Common stock, $0.001 par value; 100,000,000 and Nil shares authorized at September 30, 2006 and December 31, 2005, respectively; 16,157,991 and Nil shares issued and outstanding at September 30, 2006 and December 31, 2005, respectively | 16 |
|
— |
|
||||||||
Additional paid-in capital | 194,426 |
|
116,063 |
|
||||||||
Accumulated other comprehensive loss | (2,367 |
)
|
(2,958 |
)
|
||||||||
Deficit accumulated during the development stage | (132,741 |
)
|
(109,018 |
)
|
||||||||
Total stockholders’ equity | 59,336 |
|
4,119 |
|
||||||||
Total liabilities and stockholders’ equity | 67,520 |
|
19,071 |
|
||||||||
SEE NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
3
CYCLACEL PHARMACEUTICALS, INC.
(A
Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(Unaudited)
For
the three months ended September 30, |
For the
nine months ended September 30, |
Period from August 13, 1996 (inception) to September 30, |
||||||||||||||||||||||||||||
2006 | 2005 | 2006 | 2005 | 2006 | ||||||||||||||||||||||||||
$000, except per share and share amounts | ||||||||||||||||||||||||||||||
Revenues: |
|
|
|
|
|
|||||||||||||||||||||||||
Collaboration and research and development revenue | 27 |
|
102 |
|
152 |
|
168 |
|
2,911 |
|
||||||||||||||||||||
Grant revenue | 56 |
|
57 |
|
118 |
|
118 |
|
3,438 |
|
||||||||||||||||||||
83 |
|
159 |
|
270 |
|
286 |
|
6,349 |
|
|||||||||||||||||||||
Operating expenses:(1) |
|
|
|
|
|
|||||||||||||||||||||||||
Research and development | (4,059 |
)
|
(2,932 |
)
|
(17,196 |
)
|
(12,095 |
)
|
(117,966 |
)
|
||||||||||||||||||||
General and administrative | (2,511 |
)
|
(985 |
)
|
(9,456 |
)
|
(3,656 |
)
|
(33,089 |
)
|
||||||||||||||||||||
Other restructuring costs | (225 |
)
|
— |
|
(225 |
)
|
— |
|
(225 |
)
|
||||||||||||||||||||
Total operating expenses | (6,795 |
)
|
(3,917 |
)
|
(26,877 |
)
|
(15,751 |
)
|
(151,280 |
)
|
||||||||||||||||||||
Operating loss | (6,712 |
)
|
(3,758 |
)
|
(26,607 |
)
|
(15,465 |
)
|
(144,931 |
)
|
||||||||||||||||||||
Other income (expense): |
|
|
|
|
|
|||||||||||||||||||||||||
Costs associated with aborted 2004 IPO | — |
|
— |
|
— |
|
— |
|
(3,550 |
)
|
||||||||||||||||||||
Change in valuation of derivative | (64 |
)
|
— |
|
(162 |
)
|
— |
|
(162 |
)
|
||||||||||||||||||||
Interest income | 793 |
|
196 |
|
1,565 |
|
604 |
|
7,844 |
|
||||||||||||||||||||
Interest expense | (52 |
)
|
(15 |
)
|
(178 |
)
|
(54 |
)
|
(3,840 |
)
|
||||||||||||||||||||
Total other income (expense) | 677 |
|
181 |
|
1,225 |
|
550 |
|
292 |
|
||||||||||||||||||||
Loss before taxes | (6,035 |
)
|
(3,577 |
)
|
(25,382 |
)
|
(14,915 |
)
|
(144,639 |
)
|
||||||||||||||||||||
Income tax benefit | (603 |
)
|
(601 |
)
|
(1,659 |
)
|
(1,506 |
)
|
(11,898 |
)
|
||||||||||||||||||||
Net loss | (5,432 |
)
|
(2,976 |
)
|
(23,723 |
)
|
(13,409 |
)
|
(132,741 |
)
|
||||||||||||||||||||
Dividends on Preferred Ordinary shares | — |
|
(2,967 |
)
|
(2,827 |
)
|
(8,910 |
)
|
(38,122 |
)
|
||||||||||||||||||||
Net loss applicable to ordinary shareholders | (5,432 |
)
|
(5,943 |
)
|
(26,550 |
)
|
(22,319 |
)
|
(170,863 |
)
|
||||||||||||||||||||
Net loss per share – basic and diluted | $ | (0.34 |
)
|
$ | (0.77 |
)
|
$ | (2.07 |
)
|
$ | (2.88 |
)
|
|
|||||||||||||||||
Weighted average shares | 16,157,991 |
|
7,761,453 |
|
12,806,491 |
|
7,761,453 |
|
|
|||||||||||||||||||||
(1) Amounts include stock-based compensation, consisting of stock-based compensation expense under SFAS 123R, the amortization of deferred stock-based compensation and the value of options issued to non-employees for services rendered, allocated as follows: |
For
the three months ended September 30, |
For the
nine months ended September 30, |
Period
from August 13, 1996 (inception) to September 30, |
||||||||||||||||||||||||||||
2006 | 2005 | 2006 | 2005 | 2006 | ||||||||||||||||||||||||||
$000 | $000 | $000 | $000 | $000 | ||||||||||||||||||||||||||
Research and development | 164 |
|
(668 |
)
|
6,052 |
|
103 |
|
7,918 |
|
||||||||||||||||||||
General and administrative | 93 |
|
(129 |
)
|
3,262 |
|
76 |
|
3,950 |
|
||||||||||||||||||||
257 |
|
(797 |
)
|
9,314 |
|
179 |
|
11,868 |
|
|||||||||||||||||||||
SEE NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
4
CYCLACEL PHARMACEUTICALS, INC.
(A
Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE
LOSS
(Unaudited)
For
the three months ended September 30, |
For the
nine months ended September 30, |
Period from August 13, 1996 (inception) to September 30, |
||||||||||||||||||||||||||||
2006 | 2005 | 2006 | 2005 | 2006 | ||||||||||||||||||||||||||
$000 | $000 | $000 | $000 | $000 | ||||||||||||||||||||||||||
Net loss | (5,432 |
)
|
(2,976 |
)
|
(23,723 |
)
|
(13,409 |
)
|
(132,741 |
)
|
||||||||||||||||||||
Currency translation | 91 |
|
54 |
|
591 |
|
(1,636 |
)
|
(2,367 |
)
|
||||||||||||||||||||
Comprehensive loss | (5,341 |
)
|
(2,922 |
)
|
(23,132 |
)
|
(15,045 |
)
|
(135,108 |
)
|
||||||||||||||||||||
SEE NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
5
CYCLACEL PHARMACEUTICALS, INC.
(A
Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF
CASH
FLOWS
(Unaudited)
For
the nine months ended September 30, |
Period
from August 13, 1996 (inception) to September 30, |
|||||||||||||||||
2006 | 2005 | 2006 | ||||||||||||||||
$000 | $000 | $000 | ||||||||||||||||
Cash flows from operating activities: |
|
|
|
|||||||||||||||
Net loss | (23,723 |
)
|
(13,409 |
)
|
(132,741 |
)
|
||||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|||||||||||||||
Amortization of investment premiums, net | (11 |
)
|
— |
|
(11 |
)
|
||||||||||||
Change in valuation of derivative | 162 |
|
— |
|
162 |
|
||||||||||||
Depreciation and amortization | 869 |
|
1,037 |
|
8,834 |
|
||||||||||||
Deferred revenue | — |
|
— |
|
(98 |
)
|
||||||||||||
Compensation for warrants issued to non employees | — |
|
— |
|
1,215 |
|
||||||||||||
Shares issued for IP rights | — |
|
— |
|
446 |
|
||||||||||||
Loss on disposal of property, plant and equipment | (1 |
)
|
— |
|
24 |
|
||||||||||||
Stock based compensation | 9,314 |
|
179 |
|
11,868 |
|
||||||||||||
Provision for restructuring | 225 |
|
— |
|
225 |
|
||||||||||||
Amortization of issuance costs of Preferred Ordinary ‘‘C’’ shares | — |
|
— |
|
2,517 |
|
||||||||||||
Changes in operating assets and liabilities: |
|
|
|
|||||||||||||||
Prepaid expenses and other current assets | (496 |
)
|
1,740 |
|
(3,216 |
)
|
||||||||||||
Accounts payable and other current liabilities | (3,120 |
)
|
(408 |
)
|
1,144 |
|
||||||||||||
Net cash used in operating activities | (16,781 |
)
|
(10,861 |
)
|
(109,631 |
)
|
||||||||||||
Investing activities: |
|
|
|
|||||||||||||||
Purchase of property, plant and equipment | (133 |
)
|
(72 |
)
|
(6,136 |
)
|
||||||||||||
Proceeds from sale of property, plant and equipment | 23 |
|
— |
|
23 |
|
||||||||||||
Short-term investments on deposit, net of maturities | 1,110 |
|
281 |
|
(9,400 |
)
|
||||||||||||
Net cash provided by (used in) investing activities | 1,000 |
|
209 |
|
(15,513 |
)
|
||||||||||||
Financing activities: |
|
|
|
|||||||||||||||
Payment of capital lease obligations | (197 |
)
|
(235 |
)
|
(3,547 |
)
|
||||||||||||
Proceeds from issuance of ordinary and preferred ordinary shares, net of issuance costs | — |
|
— |
|
90,858 |
|
||||||||||||
Proceeds from issuance of common stock and warrants, net of issuance costs | 42,626 |
|
— |
|
42,626 |
|
||||||||||||
Payment of preferred stock dividend | (614 |
)
|
|
(614 |
)
|
|||||||||||||
Repayment of government loan | — |
|
— |
|
(455 |
)
|
||||||||||||
Government loan received | — |
|
— |
|
414 |
|
||||||||||||
Loan received from parent company | — |
|
9,224 |
|
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 |
|
— |
|
17,915 |
|
||||||||||||
Short-term investments assumed on stock purchase | 3,239 |
|
— |
|
3,239 |
|
||||||||||||
Costs associated with stock purchase | (1,951 |
)
|
— |
|
(1,951 |
)
|
||||||||||||
Net cash provided by (used in) financing activities | 61,018 |
|
8,989 |
|
168,116 |
|
||||||||||||
Effect of exchange rate changes on cash and cash equivalents | 1,433 |
|
(839 |
)
|
6,815 |
|
||||||||||||
Net increase (decrease) in cash and cash equivalents | 45,237 |
|
(1,663 |
)
|
42,972 |
|
||||||||||||
Cash and cash equivalents at beginning of period | 3,117 |
|
7,766 |
|
— |
|
||||||||||||
Cash and cash equivalents at end of period | 49,787 |
|
5,264 |
|
49,787 |
|
||||||||||||
6
For
the nine months ended September 30, |
Period
from August 13, 1996 (inception) to September 30, |
|||||||||||||||||
2006 | 2005 | 2006 | ||||||||||||||||
$000 | $000 | $000 | ||||||||||||||||
Supplemental disclosure of cash flows information: |
|
|
|
|||||||||||||||
Cash received during the period for: |
|
|
|
|||||||||||||||
Interest | 1,625 |
|
618 |
|
7,733 |
|
||||||||||||
Taxes | 1,906 |
|
2,473 |
|
10,739 |
|
||||||||||||
Cash paid during the period for: |
|
|
|
|||||||||||||||
Interest | (78 |
)
|
(51 |
)
|
(821 |
)
|
||||||||||||
Schedule of non-cash transactions: |
|
|
|
|||||||||||||||
Acquisitions of equipment purchased through capital leases | — |
|
— |
|
3,470 |
|
||||||||||||
Issuance of Ordinary 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 |
|
||||||||||||
Deferred stock-based compensation | 9,314 |
|
179 |
|
11,868 |
|
||||||||||||
SEE NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
7
CYCLACEL
PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
SEPTEMBER 30,
2006
(Unaudited)
1. ORGANIZATION OF THE COMPANY
Cyclacel Pharmaceuticals, Inc. (‘‘Cyclacel’’, or the ‘‘Company’’) was incorporated in the state of Delaware in 1996 and is headquartered in Short Hills, New Jersey with research facilities located in Dundee, Scotland and Cambridge, England. Cyclacel is a development-stage biopharmaceutical company dedicated to the discovery, development and eventual commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. 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 properties, raising capital and recruiting and training personnel.
Recent Corporate History
On March 27, 2006, Xcyte Therapies Inc. (‘‘Xcyte’’) completed a Stock Purchase Agreement (the ‘‘Stock Purchase Agreement’’) with Cyclacel Group plc (‘‘Group’’), a public company organized under the laws of England and Wales in which Xcyte agreed to purchase from Group all of the capital stock of Cyclacel Limited (‘‘Limited’’), a private limited company organized under the laws of England and Wales and a wholly-owned subsidiary of Group (the ‘‘Stock Purchase’’). Under the terms of the Stock Purchase Agreement, Xcyte issued 7,761,453 shares of common stock to Group which, after giving effect to the transaction, represented 79.7% of the outstanding shares of Xcyte’s common stock. Limited became Xcyte’s wholly owned subsidiary. Xcyte changed its name to Cyclacel Pharmaceuticals, Inc. On March 27, 2006, Group effected a members’ voluntary liquidation in accordance with its certificate of incorporation, memorandum and articles of association and the applicable laws of England and Wales, which has resulted in the distribution of its assets, including the Xcyte common stock it received in the Stock Purchase, to its shareholders and creditors. The transaction has been accounted for as a reverse acquisition under the purchase method of accounting for business combinations in accordance with accounting principles generally accepted in the United States and Limited is considered the acquiring company for accounting purposes. Accordingly, the purchase price has been allocated among the fair values of the assets and liabilities of Xcyte, while the historical results of Limited are reflected in the results of the Company.
Prior to the Stock purchase, on March 24, 2006 Xcyte completed an Asset Purchase Agreement (the ‘‘Asset Purchase Agreement’’) with Invitrogen Corporation, a Delaware corporation (‘‘Invitrogen’’), in which Invitrogen agreed to purchase Xcyte’s T cell expansion technology known as the ‘‘Xcellerate Process’’ in exchange for $5 million (the ‘‘Asset Sale’’). The purchase price is subject to a post-closing adjustment pursuant to which Xcyte can be required to refund up to $1 million to Invitrogen. The assets subject to the agreement included intellectual property, the clinical data generated by Xcyte in the course of six clinical trials of the lead product, Xcellerated T Cells, as well as raw materials and equipment.
On March 16, 2006, Xcyte stockholders approved a one-for-ten reverse stock split of its common stock. The reverse stock split occurred immediately prior to the completion of the Stock Purchase. All information in this report relating to the number of shares, price per share, and per share amounts of common stock are presented on a post-split basis.
On April 26, 2006, Cyclacel raised gross proceeds of $45.3 million through a private placement of common stock and common stock purchase warrants. 6.43 million shares of its common stock were issued at a price of $7.00 per share. In addition, 2.57 million seven year common stock purchase warrants were issued to the investors granting them the right to purchase Cyclacel's common stock at a price of $7.00 per share.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements as of September 30, 2006 and for the three and nine month periods ended September 30, 2006 and 2005 have been prepared in
8
accordance with accounting principles generally accepted in the United States for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. The unaudited condensed interim financial statements have been prepared on the same basis as the annual financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the financial position and results of operations of Cyclacel Pharmaceuticals, Inc. have been included. Operating results for the three month and nine month periods ended September 30, 2006 are not necessarily indicative of the results that may be expected for the year ending December 31, 2006. These unaudited condensed financial statements should be read in conjunction with the Company's audited financial statements as of December 31, 2005 and 2004 and for the years ended December 31, 2005 and 2004, the nine months ended December 31, 2003 and the period from August 13, 1996 (inception) to December 31, 2005 included in the Company's Current Report on Form 8-K filed on May 16, 2006. Financial information as of December 31, 2005 has been derived from these audited consolidated financial statements.
2. STOCK BASED COMPENSATION
On January 1, 2006, the Company adopted Financial Accounting Standards Board Statement (‘‘FASB’’), Statement No. 123R, ‘‘Share-Based Payment’’ (‘‘SFAS 123R’’). SFAS 123R requires the Company to measure all share-based payment awards, including those with employees, granted, modified, repurchased or cancelled after, or that were unvested as of, January 1, 2006 at fair value. Under SFAS 123R, the fair value of stock options and other equity-based compensation must be recognized as expense in the statements of operations over the requisite service period of each award.
The Company adopted SFAS 123R using the modified prospective method of transition. Accordingly, the Company has recognized stock-based compensation expense of $9,314,000 for the nine-month period ended September 30, 2006, comprising a stock-based compensation charge of $6,971,000 for the three-month period ended March 31, 2006 in respect of outstanding share-based awards previously granted under Cyclacel Group plc’s: Cyclacel Limited Share Option Plan (‘‘1997 Plan’’), the Cyclacel Limited 2000 Employees’ Share Option Scheme under the Enterprise Management Incentive Scheme (‘‘2000 Plan’’) and the Cyclacel Group Plc Discretionary Share Option Plan (‘‘Discretionary Plan’’) and restricted stock issued to certain directors, officers and former director, and a stock-based compensation expense of $2,343,000 for the six-month period ended September 30, 2006, in respect of outstanding share-based awards granted under Cyclacel’s 2006 Stock Option and Award Plan and 2006 Stock Option and Award Plan (UK Approved SubPlan), together ‘‘2006 Plans’’.
Prior to January 1, 2006, the Company applied the intrinsic value-based method of accounting for share-based payment transactions with our employees, as prescribed by Accounting Principles Board (‘‘APB’’) Opinion No. 25, ‘‘Accounting for Stock Issued to Employees’’ (‘‘APB No. 25’’) and related interpretations including Financial Accounting Standards Board Statement Interpretation (‘‘FIN’’) No. 44, ‘‘Accounting for Certain Transactions Involving Stock Compensation-An Interpretation of APB Opinion No. 25’’ Under the intrinsic value method, compensation expense was recognized only if the current market price of the underlying stock exceeded the exercise price of the share-based payment award as of the measurement date (typically the date of grant). Statement of Financial Accounting Standards No. 123, ‘‘Accounting for Stock-Based Compensation,’’ (‘‘SFAS 123’’) established accounting and disclosure requirements using a fair value-based method of accounting for stock-based employee compensation plans. The Company also followed the disclosure requirements of SFAS 123 and Statement of Financial Accounting Standards No. 148, ‘‘Accounting for Stock-Based Compensation — Transition and Disclosure’’.
SFAS 123(R) 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 award's stated vesting term. The Company has elected to use the straight-line attribution method to recognize expense for all awards with graded or cliff vesting. The Company used the tranche specific attribution method for stock option and nonvested share awards with graded vesting issued prior to the adoption of SFAS 123(R). All share-based awards issued after the adoption of SFAS 123(R) will
9
be expensed under the straight-line attribution method. The amount of share-based compensation recognized during a period is based on the value of the portion of the awards that are expected to vest. SFAS 123(R) 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 will be evaluated quarterly and the forfeiture rate will be adjusted as necessary. Ultimately, the actual expense recognized over the vesting period will be based on only those shares that vest.
Had compensation expense been recognized for stock-based compensation plans in accordance with SFAS No. 123, the Company would have recorded the following net loss and net loss per share amounts for the three and nine month periods ended September 30, 2005 (in thousands):
3
months ended September 30, 2005 |
9 months ended September 30, 2005 |
|||||||||||
Net loss: |
|
|
||||||||||
As reported | $ | (5,943 |
)
|
$ | (22,319 |
)
|
||||||
Add: Employee stock based compensation expense included in reported net loss, net of related tax effects | (797 |
)
|
179 |
|
||||||||
Deduct: total employee stock based compensation expense determined under the fair value method for all awards, net of related tax effects | (425 |
)
|
(1,652 |
)
|
||||||||
Pro forma | $ | (7,165 |
)
|
$ | (23,792 |
)
|
||||||
Basic and diluted loss per common share: |
|
|
||||||||||
As reported | $ | (0.77 |
)
|
$ | (2.88 |
)
|
||||||
Pro forma | $ | (0.92 |
)
|
$ | (3.07 |
)
|
||||||
As a result of adopting SFAS No. 123R on January 1, 2006, the Company’s net loss for the three and nine-month periods ended September 30, 2006 are $257 higher and $2,548 lower, respectively, than if it had continued to account for share-based compensation under APB No. 25. Basic and diluted net loss per share for the three and nine-month periods ended September 30, 2006 are $0.02 higher and $0.20 lower, respectively, than if the Company had continued to account for share-based compensation under APB No. 25.
Stock-Based Compensation Arrangements
Prior to the Stock Purchase, Group operated a number of share option plans, which provided the opportunity to all eligible individuals, including employees of Cyclacel, to participate in the potential growth and success of Group. These were the 1997 Plan, the 2000 Plan, the SEIP, the Discretionary Plan, the Cyclacel Group Plc Savings Related Share Option Plan and the Cyclacel Group Plc Restricted Share and Co- Investment Plan collectively referred to as the ‘‘Cyclacel Plans’’. Options had only been issued under the 1997 Plan, the 2000 Plan, the Discretionary Plan and the SEIP.
Similarly Xcyte operated a number of share option plans, the Amended and Restated 2003 Directors’ Stock Option Plan (‘‘2003 Directors’ Plan’’), the Amended and Restated 1996 Stock Option Plan (‘‘1996 Plan’’) and the 2003 Stock Plan (‘‘2003 Plan’’), collectively referred to as the ‘‘Xcyte Plans’’.
The completion of the Stock Purchase, the asset sale to Invitrogen and the members’ voluntary liquidation of Group variously caused an acceleration of vesting of options according to the terms of each of the Plans as described below.
Acceleration of Options
Cyclacel Plans
The vesting of all options granted pursuant to the 1997 Plan, 2000 Plan and Discretionary Plan were accelerated on the members’ voluntary liquidation of Cyclacel Group plc. As a result of this
10
acceleration, any holder of options granted pursuant to these Plans had the right to exercise one hundred percent (100%) of the options held by such holder pursuant to such plan. However, prior to the completion of the Stock Purchase and liquidation of Cyclacel Group plc all Cyclacel employees waived their rights to exercise any options held by them. The number of options of common stock that would have become fully vested as a result of the accelerated vesting provisions of the Plans was 1,369,757. However, as the liquidation of Cyclacel Group plc was probable at the time the options were waived and the liquidation caused the acceleration of the vesting of the options, the previously unrecognized compensation cost associated with these awards has been charged as employee compensation immediately prior to the consummation of the Stock Purchase on March 27, 2006. Options granted pursuant to the Senior Executive Incentive Plan only became vested on occurrence of certain trigger events and the passage of time thereafter; moreover, there were no provisions for an acceleration of vesting on liquidation. Directors benefiting from this plan waived their rights to any options held by them and concurrently the directors were issued with restricted stock as detailed below. Accordingly, as the options had never vested and were improbable of vesting even absent the liquidation, no compensation charge associated with these awards has been charged as employee expense in this period. There were no Cyclacel common stock options outstanding on completion of the Stock Purchase or liquidation of Group.
Xcyte Plans
The vesting of all options granted pursuant to the 2003 Directors’ Plan accelerated immediately upon the closing of the Stock Purchase and the asset sale to Invitrogen. As a result of this acceleration, any holder of options granted pursuant to the 2003 Directors Plan had the right to exercise one hundred percent (100%) of the options held by such holder pursuant to such plan. The number of options of common stock that became fully vested as a result of the accelerated vesting provisions of the Plan was 5,281.
The vesting of 25% of the unvested options granted pursuant to the 1996 Plan accelerated immediately upon the closing of the Stock Purchase and the asset sale to Invitrogen pursuant to the terms of the 1996 Plan. As a result of this acceleration, any holder of options granted pursuant to the 1996 Plan had the right to exercise 25% of all unvested options held by such holder under the plan. The number of options of common stock that became fully vested as a result of the accelerated vesting provisions of the Plan was 17,431.
The vesting of up to 25% of the total options granted under any award pursuant to the 2003 Plan accelerated immediately upon the closing of the Stock Purchase and the asset sale to Invitrogen pursuant to the terms of the 2003 Plan. As a result of this acceleration, any holder of options under the 2003 Stock Plan had the right to exercise the lesser of 25% of the options granted to such holder under the 2003 Stock Plan award or all remaining unvested options granted to the holder under the award pursuant to such plan. In addition, any holder of such options who is involuntarily terminated within 12 months of the closing of the transaction will have the right to exercise the lesser of an additional 25% of the options granted to such holder under the 2003 Plan award or all remaining unvested options granted to the holder under the award pursuant to such plan, for a total of 50% of the options granted to such holder under the 2003 Stock Plan award or all remaining unvested options granted to the holder under the award pursuant to such plan. The number of shares of the common stock that became fully vested as a result of the accelerated vesting provisions of the Plan was 21,779.
New Plans
On March 16, 2006, Xcyte stockholders approved the adoption of 2006 Plans, under which Cyclacel, following the acquisition in March 2006, is now able to make equity incentive grants to its officers, employees, directors and consultants. There are 1,615,795 shares of Cyclacel common stock reserved for issue under the equity incentive plan. As of the date of this report, a total of 845,746 options have been granted pursuant to the 2006 Plans. In the second quarter of 2006, we granted 829,079 stock options under the 2006 Plans In the second quarter of 2006, we granted 829,079 stock options under the 2006 Plans, of which two-thirds of the options vested immediately on grant. The remaining unvested options become fully vested 12 months following the date of grant of the options, June 13, 2007. In the third quarter of 2006 we granted 16,667 stock options under the 2006 Plans
11
which vest ratably over the three years to August 1, 2009. The total fair value of all options granted under the 2006 Plans is $3,180,000. In respect of these options, $765,000 of compensation expense has not been recognized at September 30, 2006. A further 48,333 options over common stock have been approved for grant to an employee on October 31, 2006.
In connection with the approval of the equity incentive the holders of Xcyte common stock approved the partial termination of Xcyte’s 2003 Employee Stock Purchase Plan, Amended and Restated 1996 Stock Option Plan, Amended and Restated 2003 Directors’ Stock Option Plan and 2003 Stock Option Plan. As a result of such partial termination, no options will be issued under such plans. However, such partial termination will not affect the rights of holders of stock options outstanding under such stock option plans.
A summary of activity for the options under our share option plans for the nine months ended September 30, 2006 is as follows:
Options | Weighted Average Exercise Price |
Weighted Average Remaining Contractual Term (years) |
Aggregate Intrinsic Value (in millions) |
|||||||||||||||||||||
Balance as of January 1, 2006 | 3,188,390 |
|
$ | 1.21 |
|
8.49 |
|
5.43 |
|
|||||||||||||||
Assumed on Stock Purchase | 44,491 |
|
$ | 34.91 |
|
7.82 |
|
— |
|
|||||||||||||||
Granted | 845,746 |
|
$ | 6.37 |
|
9.75 |
|
— |
|
|||||||||||||||
Exercised | — |
|
— |
|
— |
|
— |
|
||||||||||||||||
Expired | — |
|
— |
|
— |
|
— |
|
||||||||||||||||
Cancelled/forfeited | (3,229,474 |
)
|
$ | 1.59 |
|
8.49 |
|
5.43 |
|
|||||||||||||||
Balance as of September 30, 2006 | 849,153 |
|
$ | 6.66 |
|
9.72 |
|
— |
|
|||||||||||||||
Vested and unvested expected to vest at September 30, 2006 | 630,526 |
|
$ | 6.79 |
|
9.70 |
|
— |
|
|||||||||||||||
Vested and exercisable at September 30, 2006 | 630,526 |
|
$ | 6.79 |
|
9.70 |
|
— |
|
|||||||||||||||
The assumptions used in valuing stock option awards granted during 2006, along with weighted-average grant date fair value are shown below.
For
the nine months ended September 30, 2006 |
||||||
Expected term | 3-5 years | |||||
Risk free Interest rate | 4.56-5.06 |
%
|
||||
Volatility | 90 |
%
|
||||
Dividends | 0.00 |
%
|
||||
Resulting weighted average grant date fair value | $ | 3.86 |
|
|||
The expected term assumption was estimated using the ‘‘simplified method’’, as described in Staff Accounting Bulletin No. 107, ‘‘Share-Based Payment.’’ This method estimates the expected term of an option based on the average of the vesting period and the contractual term of an option award.
The expected volatility assumption was based on the historical volatility of our common stock since the first day we became publicly traded (August 2000).
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, we use the weighted average of the two Federal Reserve securities closest to the expected term of the employee option.
Dividend yield has been assumed to be zero as (a) we have never declared or paid any dividends and (b) do not currently anticipate paying any cash dividends on our outstanding shares of common stock in the foreseeable future.
12
In calculating the fair value of option awards granted after January 1, 2006, we, for the most part, used the same methodologies and assumptions employed prior to our adoption of SFAS 123R. For instance, our estimate of expected volatility is based exclusively on our historical volatility, since we have granted options that vest purely based on the passage of time and otherwise meet the criteria to exclusively rely on historical volatility, as set out in Staff Accounting Bulletin No. 107, ‘‘Share-based Payment’’.
In the first quarter of 2006 prior to the completion of the Stock Purchase, 1,750,000 shares of Cyclacel Group plc preferred stock was granted to certain directors, officers and a former director. These shares converted to 648,412 shares of restricted common stock of the Company on completion of the Stock Purchase. Because the shares granted are not subject to additional future vesting or service requirements, the stock-based compensation expense of $5,181,000 recorded in the first quarter of 2006 constitutes the entire grant-date fair value of this award, and no future period charges will be recorded. The stock is restricted only in that it cannot be sold for a specified period of time. There are no vesting requirements. The fair value of the stock granted was $7.99 per share based on the market price of the Company’s common stock on the date of grant. There were no discounts applied for the effects of the restriction, since the value of the restriction is considered to be de minimis. Certain of the restricted stock was issued as a replacement for the previously held stock based compensation awards and the incremental fair value of the restricted stock over the original award at the date of replacement has been charged to expense during the nine-months ended September 30, 2006. Of the $5,181,000 charge, $3,165,000 was reported as a component of research and development expense and $2,016,000 was reported as a component of general and administrative expense.
There was no cash received from stock option exercises for the three months or nine months ended September 30, 2006. No income tax benefits would have been recorded if there had been stock option exercises. SFAS 123R prohibits recognition of tax benefits for exercised stock option until such benefits are realized. As we presently have tax loss carry forwards from prior periods and expect to incur tax losses in 2006, we would not be able to benefit from the deduction for exercised stock option in the current reporting period.
Cash used to settle equity instruments granted under share-based payment arrangements amounted to $Nil during all periods presented.
3. COMMITMENTS AND CONTINGENCIES
The Company has contractual obligations on leases of office and manufacturing space as follows (in thousands):
Years Ending December 31, | Operating Leases | |||||
For the remainder of 2006 | $ | 444 |
|
|||
2007 | 1,810 |
|
||||
2008 | 1,859 |
|
||||
2009 | 1,908 |
|
||||
2010 | 1,756 |
|
||||
Total | $ | 7,777 |
|
|||
Rent expense, which includes lease payments related to the Company’s research and development facilities and corporate headquarters and other rent related expenses, was $137,000, $308,000, $423,000 and $795,000 for the three month and nine month periods ended September 30, 2005 and 2006, respectively.
In October 2000, the Company entered into a 25-year lease for its research and development facility in Dundee, Scotland. The Company also leases a second research facility at the Babraham Research Campus, Cambridge, England. The Company entered into this five-year lease in August 2005. There is an option to terminate the lease on July 31, 2007 at a cost to the Company of $104,000.
Additionally, the Company currently leased a total of approximately 52,100 square feet of space at two former Xcyte facilities. The Company leased approximately 11,600 square feet of office space in
13
Seattle, Washington, with monthly payments of approximately $19,000. The lease on this space expired in September 2006, and the Company has not renewed the lease. The Company also leases approximately 40,500 square feet of space in Bothell, Washington, with monthly payments of approximately $80,000. The lease term on this space expires December 2010. However, activities were discontinued at the Bothell facility during the third quarter of 2005 and the Company is exploring options for the future of this facility. Market conditions for subleasing space in Bothell are currently considered poor primarily due to an overabundance of available space. Accordingly, following the Stock Purchase on March 27, 2006, the Company recorded an accrued restructuring liability which was computed as the present value of the difference between the remaining lease payments due less the estimate of net sublease income and expenses. In relation to the Bothell facility, during September 2006, the Company entered into an Exclusive Subleasing Agency Agreement under which commissions will be calculated and payable as follows: $450,000 upon sublease execution within the first six month, $350,000 upon sublease execution within the first twelve months, $250,000 upon sublease execution within the first eighteen months. The commission payable is based upon a tenant leasing the entire facility for the remaining balance of the master lease term. In the event a tenant leases either less space or for a period less than the remaining term, then a prorated fee would be applied as per the term and square footage leased. As of September 30, 2006 the accrued restructuring liability was $2.6 million. This represents the Company's best estimate of the fair value of the liability as determined under SFAS No. 146, ‘‘Accounting for Costs Associated with Exit or Disposal Activities.’’ Subsequent changes in the liability due to accretion, or changes in estimates of sublease assumptions, etc. will be recognized as adjustments to restructuring charges in future periods.
The Company records payments of rent related to the Bothell facility as a reduction in the amount of the accrued restructuring liability. Accretion expense is recognized due to the passage of time, which is also reflected as a restructuring charge. Based on our current projections of estimated sublease income and a discount rate of 7.8%, the Company expects to record additional accretion expense of approximately $423,000 over the remaining term of the lease.
In connection with the abandonment of the leasehold improvements in the Seattle and Bothell facilities and the sale of assets in late 2005 the Company has been subjected to a State sales tax audit by the Department of Revenue of the State of Washington. In January 2006, the Company received tax assessments from the Department of Revenue of the State of Washington with respect to its utilization of the high-technology sales and use tax deferral program. Under the high-technology sale and use tax deferral program qualified Washington companies, such as the Company, are allowed to defer sales tax on purchases of qualified assets used in research and development activities. The deferred sales taxes are then forgiven by the State, generally over a period of eight years. According to the assessments, if the deferral program requirements continue to be met, the tax assessment will be waived. The total tax liability assessed by the State of Washington equals approximately $1 million. The Company’s management believes that the majority of the assets which previously qualified for the State of Washington sales tax deferral program continue to qualify as they have been retained by the Company or have been or will be sold or transferred to a qualified entity for qualified purposes. We are in the process of discussing the potential sales tax liability with the Department of Revenue of the State of Washington and have appealed the assessment. The appeal is based on an evaluation of the extent to which the abandoned and disposed of assets have been rendered obsolete, sold or leased to eligible entities that continue to use the assets for purposes qualified under the program. The ultimate amount of the assessment that will be payable is dependent upon rulings and interpretations of the State tax laws related to this program. Based on an evaluation of the underlying asset dispositions and State tax law management believes that the potential loss from the ultimate settlement of the assessment ranges from $270,000 to $1 million. Based on this evaluation Xcyte accrued $270,000 as a State tax assessment in 2005 and such amount is included in the accompanying balance sheet as a component of accrued liabilities.
In October 2006, the Company entered into a 5-year lease for office space in Berkeley Heights, New Jersey. On completion of the refurbishment of this office space the Company’s corporate headquarters will be relocated from Short Hills to Berkeley Heights.
14
On March 24, 2006 Xcyte completed an Asset Purchase Agreement (the ‘‘Asset Purchase Agreement’’) with Invitrogen Corporation, a Delaware corporation (‘‘Invitrogen’’), in which Invitrogen agreed to purchase Xcyte’s T cell expansion technology known as the ‘‘Xcellerate Process’’ in exchange for $5 million (the ‘‘Asset Sale’’). The purchase price is subject to a post-closing adjustment pursuant to which Xcyte can be required to refund up to $1 million to Invitrogen. The assets subject to the agreement include intellectual property, the clinical data generated by Xcyte in the course of six clinical trials of the lead product, Xcellerated T Cells, as well as raw materials and equipment.
On July 28, 2005, Cyclacel Group plc signed a convertible Loan Note Instrument constituting convertible unsecured loan notes. On July, 28, 2005, it entered into a Facility Agreement with Scottish Enterprise, as lender, whereby Scottish Enterprise subscribed for £5 million ($8.8 million) of the convertible loan notes. Upon the completion of the Stock Purchase, the convertible loan notes held by Scottish Enterprise converted into 1,231,527 preferred ‘‘D’’ shares in satisfaction of all amounts owed by Group under the convertible loan notes. The number of preferred ‘‘D’’ shares that Scottish Enterprise received was calculated by dividing the principal amount outstanding under the loan note by £4.06. Scottish Enterprise retains the ability it had under the Facility Agreement to receive a cash payment should the research operations in Scotland be significantly reduced. However, Cyclacel Limited will guarantee the amount potentially due to Scottish Enterprise which will be calculated as a maximum of £5 million less the market value of the shares held (or would have held in the event they dispose of any shares) by Scottish Enterprise at the time of any significant reduction in research facilities during the period ending on July 28, 2010.
4. MERGER
On March 27, 2006, Xcyte completed the Stock Purchase Agreement with Group for a transaction to be accounted for as a purchase under accounting principles generally accepted in the United States. The Stock Purchase was approved by Xcyte shareholders on March 16, 2006 and Group shareholders on March 27, 2006. Under the terms of the transaction, Xcyte issued 7,761,453 shares of its common stock (equivalent to 776,145 shares after adjustment for a 1 for 10 reverse stock split which occurred on March 27, 2006) for all of Limited’s outstanding shares of common stock. For accounting purposes, the transaction is considered a ‘‘reverse merger’’ under which Limited is considered the acquirer of Xcyte. Accordingly, the purchase price was allocated among the fair values of the assets and liabilities of Xcyte, while the historical results of Limited are reflected in the results of the combined company. The 1,967,966 shares of Xcyte common stock outstanding, the 2,046,813 preferred stock outstanding and the outstanding Xcyte options, are considered as the basis for determining the consideration in the reverse merger transaction. Based on the outstanding shares of Group capital stock on March 27, 2006, each share of Group preferred stock was exchanged for approximately 0.37 shares of Xcyte common stock.
Each Limited and Group stock option and warrant that was not converted prior to the consummation of the Stock Purchase was cancelled and there were no outstanding Limited or Group options and warrants on closing.
Merger Purchase Price
The consolidated financial statements reflect the merger of Limited with Xcyte as a reverse merger wherein Limited is deemed to be the acquiring entity from an accounting perspective. Under the purchase method of accounting, Xcyte’s outstanding shares of common and preferred stock were valued using the average closing price on Nasdaq of $4.38 (as adjusted for the reverse stock split) and $3.72 per share for common stock and preferred stock, respectively, for the two days prior to through the two days subsequent to the announcement of the transaction date of December 15, 2005. There were 1,967,967 shares of common stock and 2,046,813 shares of preferred stock outstanding as of March 27, 2006. The fair values of the Xcyte outstanding stock options were determined using the Black-Scholes option pricing model with the following assumptions: stock price of $4.38 (as adjusted for the reverse stock split), volatility of 0.97; risk-free interest rate of 4.0%; and an expected life of three months.
15
The purchase price is summarized as follows (in thousands):
Fair value of Xcyte outstanding common stock | $ | 8,620 |
|
|||
Fair value of Xcyte outstanding preferred stock | 7,618 |
|
||||
Fair value of Xcyte outstanding stock options | 17 |
|
||||
Estimated merger costs | 1,951 |
|
||||
Total purchase price | $ | 18,206 |
|
|||
Merger Purchase Price Allocation
The purchase price allocation is as follows (in thousands):
Current assets | $ | 21,267 |
|
|||
Property, plant and equipment | 108 |
|
||||
Other assets | 259 |
|
||||
Current liabilities | (4,400 |
)
|
||||
Non-current liabilities | (1,777 |
)
|
||||
Goodwill | 2,749 |
|
||||
$ | 18,206 |
|
||||
Pro Forma Results of Operations
The results of operations of Xcyte are included in Cyclacel’s condensed consolidated financial statements from the date of the business combination transaction as of March 27, 2006. The following table presents pro forma results of operations and gives effect to the business combination transaction as if the business combination was consummated at the beginning of the period presented. The unaudited pro forma results of operations are not necessarily indicative of what would have occurred had the business combination been completed at the beginning of the retrospective periods or of the results that may occur in the future.
For
the nine months ended September 30, |
||||||||||||
2006 | 2005 | |||||||||||
$000 | $000 | |||||||||||
Revenues | 5,270 |
|
325 |
|
||||||||
Loss before taxes | (24,540 |
)
|
(40,745 |
)
|
||||||||
Net loss applicable to ordinary shareholders | (25,708 |
)
|
(48,149 |
)
|
||||||||
Net loss per share-basic and diluted | $ | (2.01 |
)
|
$ | (6.20 |
)
|
||||||
Weighted average shares | 12,806,491 |
|
7,761,453 |
|
||||||||
5. AMOUNTS DUE TO CYCLACEL GROUP PLC
Prior to the completion of the Stock Purchase, Cyclacel Limited was a wholly owned subsidiary of Cyclacel Group plc. The amounts outstanding of $Nil and $10,467,000 as of September 30, 2006 and December 31, 2005, respectively, are a result of intercompany transactions which occurred prior to the completion of the Stock Purchase. Cyclacel Pharmaceuticals, Inc. settled the outstanding amounts and as a consequence eliminated the balance due to Cyclacel Group plc. During the three months ended September 30, 2006, Cyclacel paid certain advisors $36,000 in connection with the members' voluntary liquidation of Cyclacel Group plc with the remaining balance of $181,000 being waived and set against Additional Paid-in Capital, reducing the amounts outstanding from $217,000 at June 30, 2006 to $Nil at September 30, 2006.
16
6. STOCKHOLDERS’ EQUITY
Reverse Stock Split and Issue of Common Stock in Connection with the Stock Purchase Agreement
In March 2006, the Board of Directors and stockholders of the Company approved an amendment to the Company’s eighth amended and restated certificate of incorporation effecting a 1-for-10 reverse stock split of common stock, (the ‘‘Reverse Stock Split’’). The Reverse Stock Split occurred immediately prior to the completion of the Stock Purchase. All issued and outstanding common stock and per share amounts contained in the financial statements have been retroactively adjusted to reflect this stock split, except as specifically indicated.
Stock Purchase Agreement
In March 2006, in connection with the Stock Purchase Agreement the Company issued 7,761,453 shares of common stock (equivalent to 776,145 shares after adjustment for a 1 for 10 reverse stock split which occurred on March 27, 2006) to Cyclacel Group plc which represented 79.7% of the outstanding shares of the Company's common stock.
Stock Option Award Plan
In January 2006, the Board of Directors adopted and in March 2006, the stockholders approved the 2006 Plans. The Company had reserved a total of 986,120 shares of common stock for issuance under the 2006 Plan plus any options granted under the Company’s predecessor plans that expire unexercised or are repurchased by the Company pursuant to the terms of such options. On July 6, 2006, the stockholders approved an amendment of the 2006 Plans to increase the number of shares of common stock issuable thereunder by an additional 629,675 shares, to an aggregate of 1,615,795 shares. As of September 30, 2006, a total of 845,746 options have been issued under the 2006 Plans. A further 48,883 options have been approved for grant on October 31, 2006.
Private Placement
On April 26 2006, the Company entered into a Stock and Purchase Agreement pursuant to which it sold to certain investors, for an aggregate purchase price of $45.3 million, 6,428,572 shares of its common stock and warrants to purchase up to 2,571,429 additional shares of its common stock. The purchase price for the common stock and the exercise price for the warrants is $7.00 per share. Investors in the financing paid an additional purchase price equal to $0.125 per warrant or an additional $0.05 for each share underlying the warrants. The warrants are not exercisable until six months after the closing and have an expiration date seven years after closing.
Amounts Receivable from Directors and Officers
In connection with the issue of Group Preferred D shares to certain directors and officers in March 2006 prior to the Stock Purchase the Company was obliged to withhold payroll taxes of $248,000 and remit this amount to the UK tax authorities. As this is a non-cash item the taxes cannot be withheld from the payment but must be recovered from the employee. Under the UK Income and Taxes Act these payroll taxes are recoverable from the individuals by June 27, 2006 and all amounts were recovered prior to this date.
7. RECENT ACCOUNTING PRONOUNCEMENTS
In July 2006, the FASB issued FASB Interpretation No. 48, ‘‘Accounting for Uncertainty in Income Taxes’’, an interpretation of SFAS 109, ‘‘Accounting for Income Taxes’’ (‘‘FIN 48’’), FIN 48 clarifies the accounting for uncertainty in income taxes recognized in a company's financial statements by prescribing a minimum recognition threshold a tax position is required to meet before being recognized in the financial statements. FIN 48 also provides guidance on derecognition, measurement, classification, interest and penalties, accounting in interim periods, disclosure and transition. FIN 48 is
17
effective for fiscal years beginning after December 15, 2006 and the Company will adopt FIN 48 as of January 1, 2007. The impact of adopting FIN 48 on the Company's financial position or results of operations, if any, has not yet been determined.
In September 2006, the FASB issued Statement of Financial Standards No. 157, ‘‘Fair Value Measurements’’ (‘‘SFAS 157’’). SFAS 157 defines fair value, establishes a framework for measuring fair value and requires enhanced disclosures about fair value measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007 and interim periods within those fiscal years and will be adopted by the Company as of January 1, 2008. SFAS 157 may impact our balance sheet and statement of operations in areas including the fair value measurements for derivative instruments. The Company is currently reviewing the provisions of SFAS 157 and has not yet determined the effect, if any, that adoption of SFAS 157 will have.
In September 2006, the FASB issued Statement of Financial Standards No. 158, ‘‘Employers' Accounting for Defined Benefit Pension and Other Postretirement Plans’’ (‘‘SFAS 158’’). SFAS 158 requires employers with defined benefit pension plans and other postretirement plans to fully recognize, as an asset or liability, the overfunded or underfunded status of its benefit plans in its statement of financial position and to recognize changes in that funded status in comprehensive income in the year in which changes occur. SFAS 158 also requires an employer to measure the funded status as of the date of its year-end statement of financial position. An employer with publicly traded equity securities is required to initially recognize the funded status of a defined benefit postretirement plan and to provide the required disclosures as of the end of the fiscal year ending after December 15, 2006. The requirement to measure plan assets and benefit obligations as of the date of the employer's fiscal year-end statement of financial position is effective for fiscal years ending after December 15, 2008. The Company does not expect that the adoption of SFAS 158 will have a significant impact on the Company's financial position as the Company does not operate a defined benefit pension or similar postretirement plan.
18
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This report contains certain statements that may be deemed ‘‘forward-looking statements’’ within the meaning of United States securities laws. 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. Factors that could cause results to differ materially from those projected or implied in the forward looking statements are set forth in our Annual Report on Form 10-K for the year ended December 31, 2005, as updated below under the caption ‘‘Item 1A — Risk factors’’.
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 development-stage biopharmaceutical company dedicated to the discovery, development and eventual commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. We describe drugs, compounds or molecules as mechanism-targeted if they are designed to affect identified biological processes through known mechanisms and novel if they have been recently discovered using advanced technologies. Our core area of expertise is in cell cycle biology, or the processes by which cells divide and multiply. We focus primarily on the discovery and 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 quality of life and improving survival rates of cancer patients. We have been focused on the cell cycle since our inception. We were founded in 1996 by Professor Sir David Lane, a recognized leader in the field of tumor suppressor biology who discovered the p53 protein, which operates as one of the body’s own anticancer ‘‘drugs’’ by inhibiting cell cycle targets. In 1999, we were joined by Professor David Glover, a recognized leader in the mechanism of mitosis, or cell division, who discovered, among other cell cycle targets, the mitotic kinases, Polo and Aurora, enzymes that act in the mitosis phase of the cell cycle. Our expertise in cell cycle biology is at the center of our business strategy.
We are generating several families of anticancer drugs that act on the cell cycle including Cyclin Dependent kinase (CDK) and Aurora kinase (AK) inhibitors. Although a number of pharmaceutical and biotechnology companies are currently attempting to develop CDK inhibitor drugs, we believe that our lead drug candidate, seliciclib, is the only orally available CDK inhibitor drug candidate currently in Phase IIb trials.
We are advancing three of our anticancer drug candidates, seliciclib, sapacitabine and CYC116 through in-house research and development activities. On June 29, 2006 we announced that we were beginning a Phase IIb, multi-center, randomized, double-blinded trial to evaluate the efficacy and safety of seliciclib as a third line treatment in patients with non-small cell lung cancer (NSCLC). The trial is being initiated following Food and Drug Administration and central Institutional Review Board approval of the trial protocol. The APPRAISE study builds on the observation of prolonged stable disease experienced by heavily-pretreated NSCLC patients enrolled in a Phase I study of single agent seliciclib . Sapacitabine has completed two Phase I studies evaluating 87 patients in refractory solid tumors. We are currently conducting a Phase Ib dose escalation clinical trial with sapacitabine for the treatment of patients with advanced malignancies with approximately 38 patients enrolled to
19
date. On June 15, 2006, we initiated a Phase I clinical trial of sapacitabine, an orally available nucleoside analogue, in patients with advanced leukemias or myelodysplastic syndromes (MDS). We are also developing CYC116, an Aurora kinase inhibitor, for the treatment of cancer, and we expect to file an investigational new drug application in the fourth quarter of 2006. We have worldwide rights to commercialize seliciclib, sapacitabine and CYC116 and our business strategy is to enter into selective partnership arrangements with these programs.
We have a further eight novel drug series: five for cancer, one for inflammation, one for Type 2 Diabetes, and one for HIV/AIDS. Taken together, our pipeline covers all four phases of the cell cycle, which we believe will improve the chances of successfully developing and commercializing novel drugs that work on their own or in combination with approved conventional chemotherapies or with other targeted drugs to treat human cancers.
Our corporate headquarters is located in Short Hills, New Jersey, with our main research facility located in Dundee, Scotland, and a second research facility located in Cambridge, England.
From our inception in 1996 through September 30, 2006, 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, 2006, our accumulated deficit during the development stage was $132.7 million. We expect to continue incurring substantial losses for the next several years as we continue to develop our clinical, pre-clinical and other drugs currently in development. Our operating expenses comprise research and development expenses and general and administrative expenses.
To date, we have not generated any product revenue but have financed our operations and internal growth through private placements, licensing revenue, interest on investments, government grants and research and development tax credits. We have received proceeds from the issuances of equity interests of $133.5 million from inception through September 30, 2006 which includes $42.6 million raised through the private placement of common stock and warrants in the second quarter of 2006. Our revenue has consisted of collaboration and grant revenue. We have recognized revenues from inception through September 30, 2006 of $6.3 million of which $2.9 million is derived from fees under collaborative agreements and $3.4 million of grant revenue from various United Kingdom government grant awards. We have not generated any revenue from sales of commercial products and do not expect to generate any product revenue for the foreseeable future. We have also received $11.9 million from research and development tax credits since inception.
Results of Operations
As explained in detail in the Notes to Condensed Consolidated Financial Statements — Basis of Preparation, the transaction with Xcyte was accounted for as a reverse merger and Cyclacel was considered to have acquired Xcyte on March 27, 2006. As a consequence the comparative periods for the three and nine-month periods ended September 30, 2005 reflect the results of Cyclacel only while the current three and nine-month periods ended September 30, 2006 reflect the results of the combined companies from March 28, 2006 through September 30, 2006.
20
Revenues
The following table summarizes the components of our revenues for the three and nine-month periods ended September 30, 2006 and 2005:
Three
months ended September 30, |
Nine months ended September 30, |
|||||||||||||||||||||||||||||||||||||||||||||||
2006 | 2005 | $ Difference |
% Difference |
2006 | 2005 | $ Difference |
% Difference |
|||||||||||||||||||||||||||||||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||||||||||||||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||||||||||||||||||||||||||||
Collaboration and research and development revenue | $ | 27 |
|
$ | 102 |
|
$ | (75 |
)
|
(73.53 |
)%
|
$ | 152 |
|
$ | 168 |
|
$ | (16 |
)
|
(9.52 |
)%
|
||||||||||||||||||||||||||
Grant revenue | 56 |
|
57 |
|
(1 |
)
|
(1.75 |
)%
|
118 |
|
118 |
|
— |
|
— |
|
||||||||||||||||||||||||||||||||
Total revenue | $ | 83 |
|
$ | 159 |
|
$ | (76 |
)
|
(47.80 |
)%
|
$ | 270 |
|
$ | 286 |
|
$ | (16 |
)
|
(5.59 |
)%
|
||||||||||||||||||||||||||
Collaboration and research and development revenue for the three and nine-month periods ended September 30, 2006 and 2005 is derived from several agreements under which the Company provides compounds for evaluation for an agreed consideration.
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 United Kingdom government grant awards. During the three and nine-month periods ended September 30, 2006 we recognized grant revenues of $56,000 and $118,000, respectively. For the same periods in 2005 we recognized grant revenues of $57,000 and $118,000.
Future
Subject to satisfactory progress, under existing grants we are entitled to receive further grant revenue of $280,000 on qualifying expenditure.
Research and development expenses
To date, we have focused on drug discovery and development programs, with particular emphasis on orally available anticancer agents. Research and development expense represents costs incurred to discover and develop novel small molecule therapeutics, including clinical trial costs for seliciclib and sapacitabine, to advance product candidates toward clinical trials, to develop in-house research and preclinical study capabilities and to advance our biomarker program and technology platforms. We expense all research and development costs as they are incurred. Research and development expenses primarily include:
• | payroll and personnel-related expenses, including consultants and contract research; |
• | clinical trial and regulatory-related costs; |
• | preclinical studies; |
• | screening and identification of drug candidates; |
• | laboratory supplies and materials; |
• | technology license costs; |
• | rent and facility expenses for our laboratories; and |
• | scientific consulting fees. |
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The following table provides information with respect to our research and development expenditure for the three and nine-month periods ended September 30, 2006 and 2005:
Three
months ended September 30, |
Nine months ended September 30, |
|||||||||||||||||||||||||||||||||||||||||||||||
2006 | 2005 | $ Difference |
% Difference |
2006 | 2005 | $ Difference |
% Difference |
|||||||||||||||||||||||||||||||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||||||||||||||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||||||||||||||||||||||||||||
Seliciclib | $ | 1,061 |
|
$ | 1,353 |
|
$ | (292 |
)
|
(21.58 |
)%
|
$ | 2,027 |
|
$ | 3,844 |
|
$ | (1,817 |
)
|
(47.27 |
)%
|
||||||||||||||||||||||||||
Sapacitabine | 448 |
|
487 |
|
(39 |
)
|
(8.01 |
)%
|
1,367 |
|
1,805 |
|
(438 |
)
|
(24.27 |
)%
|
||||||||||||||||||||||||||||||||
CYC116 | 1,679 |
|
1,299 |
|
380 |
|
29.25 |
%
|
5,230 |
|
3,989 |
|
1,241 |
|
31.11 |
%
|
||||||||||||||||||||||||||||||||
Other costs related to research and development programs, management and exploratory research | 707 |
|
461 |
|
246 |
|
53.36 |
%
|
2,520 |
|
2,354 |
|
166 |
|
7.05 |
%
|
||||||||||||||||||||||||||||||||
$ | 3,895 |
|
$ | 3,600 |
|
$ | 295 |
|
8.19 |
%
|
$ | 11,144 |
|
$ | 11,992 |
|
$ | (848 |
)
|
(7.07 |
)%
|
|||||||||||||||||||||||||||
Stock
based compensation |
164 |
|
(668 |
)
|
832 |
|
(124.55 |
)%
|
6,052 |
|
103 |
|
5,949 |
|
5775.73 |
%
|
||||||||||||||||||||||||||||||||
Total research and development expenses | $ | 4,059 |
|
$ | 2,932 |
|
$ | 1,127 |
|
38.44 |
%
|
$ | 17,196 |
|
$ | 12,095 |
|
$ | 5,101 |
|
42.17 |
%
|
||||||||||||||||||||||||||
Total research and development expenses represented 60% and 64% of our operating expenses for the three and nine-month periods ended September 30, 2006, and 75% and 77% for the three and nine-month periods ended September 30, 2005, respectively.
Our research and development expenditure, excluding stock-based compensation costs increased $0.3 million from $3.6 million in the three-month period ended September 30, 2005 to $3.9 million in the three-month period ended September 30, 2006 and decreased $0.9 million from $12.0 million in the nine-month period ended September 30, 2005 to $11.1 million in the nine-month period ended September 30, 2006. These fluctuations reflect the costs of completion of Phase IIa clinical trials of seliciclib in 2005 with a period of reduced spend ahead of the announcement of the Phase IIb trial in the second quarter of 2006, followed by a gradual increase as efforts are focused on intiating the recruited sites during the third quarter of 2006. We have increased research and development expenditure on CYC116 as activities focus on IND-directed studies on this program. Filing of the IND is scheduled for the fourth quarter of 2006.
Stock-based compensation attributable to research and development was an expense of $0.2 million and $6.1 million for the three and nine-month periods ended September 30, 2006, respectively. Stock-based compensation for the three and nine-month periods ended September 30, 2005 was a credit of $0.7 million and an expense of $0.1 million, respectively. See stock-based compensation discussion below for more details.
22
General and administrative expenses
General and administrative expenses include costs for administrative personnel, legal and other professional expenses and general corporate expenses. These costs are not broken out for reporting purposes. The following table summarizes the general and administrative expenses for the three and nine-month periods ended September 30, 2006 and 2005:
Three
months ended September 30, |
Nine months ended September 30, |
|||||||||||||||||||||||||||||||||||||||||||||||
2006 | 2005 | $ Difference |
% Difference |
2006 | 2005 | $ Difference |
% Difference |
|||||||||||||||||||||||||||||||||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||||||||||||||||||||||||||||||||||
(in thousands) | ||||||||||||||||||||||||||||||||||||||||||||||||
General and administrative expenses | $ | 2,418 |
|
$ | 1,114 |
|
$ | 1,304 |
|
117.06 |
%
|
$ | 6,194 |
|
$ | 3,580 |
|
$ | 2,614 |
|
73.02 |
%
|
||||||||||||||||||||||||||
Stock based compensation | 93 |
|
(129 |
)
|
222 |