Delaware | 0-50626 | 91-1707622 | ||
(State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
200 Connell Drive, Suite 1500 Berkeley Heights, NJ |
07922 |
|
(Address of principal executive offices) | (Zip Code) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Exhibit | ||||
Number | Description | |||
99.1 | Press release announcing financial results for the second quarter ended June
30, 2011, dated August 11, 2011. |
CYCLACEL PHARMACEUTICALS, INC. |
||||
By: | /s/ Paul McBarron | |||
Name: | Paul McBarron | |||
Title: | Executive Vice PresidentFinance, Chief Financial Officer and Chief Operating Officer |
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Cyclacel Pharmaceuticals, Inc. |
| Completed patient enrollment in the lead-in stage of the sapacitabine Phase 3 SEAMLESS study of elderly patients with AML who are not eligible for intensive chemotherapy. | ||
| Reported results at the 2011 ASCO meeting from a pilot study evaluating the same treatment regimen of sapacitabine dosed sequentially with decitabine, as one of the arms in SEAMLESS, the registration-directed, Phase 3 study of sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia. In the multicenter, Phase 1/2 clinical trial examining the safety and effectiveness of oral sapacitabine administered sequentially with decitabine, 30-day mortality from all causes was 4.5% and 60-day mortality from all causes was 9.5%. The overall response rate was 34.8%. | ||
| Completed an underwritten registered direct offering for an aggregate of 7,617,646 units, at an offering price of $1.36 per unit, for gross proceeds of $10.4 million. Each unit consists of (i) one share of common stock, and (ii) a five-year warrant to purchase 0.5 share of common stock at an exercise price of $1.36 per share, exercisable beginning six months after the date of issuance. | ||
| Amended the sapacitabine licensing agreement with Daiichi Sankyo, whereby Daiichi Sankyo irrevocably waived a termination right it possessed under a provision of the license agreement. The amendment further provides that the royalty 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. |
þ | 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922 USA T: +1 (908) 517 7330 F: +1 (866) 271 3466 | |
o | Dundee Technopole, James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067 |
| Continued enrolment in the sapacitabine Phase 2 study in patients with Non-Small Cell Lung Cancer, or NSCLC, who failed at least one prior therapy. | ||
| Continued collection of patient specimens from the APPRAISE randomized, double-blinded, randomized discontinuation, Phase 2b study of seliciclib in patients with NSCLC who failed at least two prior therapies. |
2
| DSMB decision to enable the commencement of the randomized part of the SEAMLESS pivotal Phase 3 study of sapacitabine in AML; |
| Presentation of additional sapacitabine data in hematological malignancies, both as a single agent and in combination with other anticancer agents; |
| Presentation of Phase 2 sapacitabine data in NSCLC; and |
| Patient biomarker analysis from the APPRAISE Phase 2b randomized discontinuation study of seliciclib in patients with NSCLC. |
3
4
Period from | ||||||||||||||||||||
August 13, | ||||||||||||||||||||
1996 | ||||||||||||||||||||
(inception) | ||||||||||||||||||||
For the three | For the six | To | ||||||||||||||||||
months ended | months ended | December | ||||||||||||||||||
June 30 | June 30 | 31, | ||||||||||||||||||
2010 | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||
($000s) | ||||||||||||||||||||
Revenues: |
||||||||||||||||||||
Collaboration and research and
development revenue |
100 | | 100 | | 3,100 | |||||||||||||||
Product revenue |
19 | 168 | 273 | 360 | 2,682 | |||||||||||||||
Grant revenue |
| | 16 | | 3,648 | |||||||||||||||
119 | 168 | 389 | 360 | 9,430 | ||||||||||||||||
Operating expenses: |
||||||||||||||||||||
Cost of goods sold |
92 | 72 | 234 | 178 | 1,570 | |||||||||||||||
Research and development |
1,322 | 1,859 | 3,497 | 4,939 | 181,482 | |||||||||||||||
General and administrative |
3,091 | 2,034 | 5,491 | 3,840 | 85,806 | |||||||||||||||
Goodwill and intangibles impairment |
| | | | 7,934 | |||||||||||||||
Restructuring costs |
| | | | 2,634 | |||||||||||||||
Total operating expenses |
4,505 | 3,965 | 9,222 | 8,957 | 279,476 | |||||||||||||||
Operating loss |
(4,386 | ) | (3,797 | ) | (8,833 | ) | (8,597 | ) | (270,046 | ) | ||||||||||
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 |
273 | 125 | (516 | ) | 203 | 6,273 | ||||||||||||||
Warrant re-pricing |
| | | | (44 | ) | ||||||||||||||
Foreign exchange gains/(losses) |
(49 | ) | (19 | ) | (38 | ) | (85 | ) | (4,342 | ) | ||||||||||
Interest income |
8 | 13 | 17 | 24 | 13,704 | |||||||||||||||
Interest expense |
(9 | ) | | (33 | ) | | (4,677 | ) | ||||||||||||
Total other income (expense), net |
223 | 119 | (570 | ) | 140 | 5,404 | ||||||||||||||
Loss before taxes |
(4,163 | ) | (3,678 | ) | (9,403 | ) | (8,457 | ) | (264,642 | ) | ||||||||||
Income tax benefit |
230 | 126 | 363 | 317 | 18,196 | |||||||||||||||
Net loss |
(3,933 | ) | (3,552 | ) | (9,040 | ) | (8,140 | ) | (246,446 | ) | ||||||||||
Dividends on preferred ordinary shares |
| | | | (38,123 | ) | ||||||||||||||
Deemed dividend on convertible
exchangeable preferred shares |
(2,496 | ) | | (2,915 | ) | | (3,515 | ) | ||||||||||||
Dividend on convertible exchangeable
preferred shares |
(114 | ) | (182 | ) | (403 | ) | (364 | ) | (3,293 | ) | ||||||||||
Net loss applicable to common stockholders |
(6,543 | ) | (3,734 | ) | (12,358 | ) | (8,504 | ) | (291,377 | ) | ||||||||||
Net loss per share basic and diluted |
$ | (0.18 | ) | $ | (0.08 | ) | $ | (0.36 | ) | $ | (0.18 | ) | ||||||||
Weighted average common shares outstanding |
36,565,972 | 46,582,915 | 34,157,279 | 46,577,577 | ||||||||||||||||
5
As of | As of | |||||||
December 31 | June 30 | |||||||
2010 | 2011 | |||||||
($000s) | ($000s) | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
29,495 | 20,614 | ||||||
Inventory |
174 | 147 | ||||||
Prepaid expenses and other current assets |
1,382 | 1,688 | ||||||
Total current assets |
31,051 | 22,449 | ||||||
Property, plant and equipment (net) |
408 | 246 | ||||||
Total assets |
31,459 | 22,695 | ||||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
1,723 | 1,104 | ||||||
Accrued and other current liabilities |
4,132 | 4,459 | ||||||
Warrants liability |
680 | 477 | ||||||
Total current liabilities |
6,535 | 6,040 | ||||||
Total liabilities |
6,535 | 6,040 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock, $0.001 par value; 5,000,000
shares authorized at December 31, 2010 and June
30, 2011, respectively; 2,046,813 and 1,213,142
shares issued and outstanding at December 31,
2010 and June 30, 2011. Aggregate preference in
liquidation (including undeclared cumulative
dividends) of $13,455,562 at December 31, 2010
and June 30, 2011 |
1 | 1 | ||||||
Common stock, $0.001 par value; 100,000,000
shares authorized at December 31, 2010 and June
30, 2011, respectively; 46,564,914 and
46,587,182 shares issued and outstanding at
December 31, 2010 and June 30, 2011,
respectively |
47 | 47 | ||||||
Additional paid in capital |
266,666 | 266,529 | ||||||
Accumulated other comprehensive loss |
31 | 39 | ||||||
Deficit accumulated during the development stage |
(241,821 | ) | (249,961 | ) | ||||
Total stockholders equity |
24,924 | 16,655 | ||||||
Total liabilities and stockholders equity |
31,459 | 22,695 | ||||||
6
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