UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 12, 2011
CYCLACEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| 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) |
Registrant’s telephone number, including area code: (908) 517-7330
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| 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)) |
Item 2.02 Results of Operations and Financial Condition.
The information set forth under this “Item 2.02. Results of Operations and Financial
Condition,” including the exhibit attached hereto, shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated
by reference into any filing under the Securities Act of 1933, as amended, except as shall be
expressly set forth by specific reference in such filing.
Attached as Exhibit 99.1 is a copy of a press release of Cyclacel Pharmaceuticals, Inc. (the
“Company”), dated May 12, 2011, announcing certain financial results for the first quarter ended
March 31, 2011.
The Company will conduct a conference call to review its financial results on Thursday, May
12, 2011, at 4:30 p.m., Eastern Time.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit | ||
| Number | Description | |
99.1
|
Press release announcing financial results for the first quarter ended March 31, 2011, dated May 12, 2011. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| CYCLACEL PHARMACEUTICALS, INC. |
||||
| By: | /s/ Paul McBarron | |||
| Name: | Paul McBarron | |||
| Title: | Executive Vice President—Finance, Chief Financial Officer and Chief Operating Officer |
|||
Date: May 12, 2011
Exhibit 99.1
|
Cyclacel Pharmaceuticals, Inc. |
CYCLACEL PHARMACEUTICALS REPORTS FINANCIAL RESULTS FOR FIRST QUARTER 2011
— Conference Call Scheduled May 12, 2011 at 4:30 p.m. Eastern Time —
Berkeley Heights, NJ, May 12, 2011 — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC,
NASDAQ: CYCCP; Cyclacel or the Company), a biopharmaceutical company developing oral therapies that
target the various phases of cell cycle control for the treatment of cancer and other serious
disorders, today reported its financial results and business highlights for the first quarter ended
March 31, 2011.
The net loss for the first quarter of 2011 was $4.6 million as compared to a net loss of $5.1
million for the same period in 2010. As of March 31, 2011, cash and cash equivalents totaled $25.4
million. The Company’s net loss applicable to common stockholders for the first quarter of 2011 was
$4.8 million or $0.10 per basic and diluted share, compared to a net loss applicable to common
stockholders of $5.8 million or $0.18 per basic and diluted share for the first quarter of 2010.
“With the SEAMLESS Phase 3 trial open and enrolling patients with acute myeloid leukemia, or AML,
Cyclacel is a step closer to our ultimate goal of getting sapacitabine to patients in need and
potentially the market,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel.
“We are looking forward to the upcoming presentation at a major medical conference of pilot study
data of sapacitabine in combination with decitabine in patients with AML. In addition, we expect
to report later this year additional sapacitabine data in hematological malignancies and non-small
lung cancer, or NSCLC, and seliciclib biopsy analysis data in NSCLC. ”
Business Highlights
| • | Opened enrollment of the SEAMLESS pivotal Phase 3 study 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 being conducted under a Special Protocol Assessment (SPA) agreement that Cyclacel reached with the U.S. Food and Drug Administration (FDA). The trial builds on promising 1-year survival observed in elderly patients aged 70 years or older with newly diagnosed AML or AML in first relapse enrolled in a Phase 2 study of single agent sapacitabine. | ||
| • | Announced publication of preclinical data in the Proceedings of the National Academy of Sciences, demonstrating that cyclin E plays a major role in making Human Epidermal growth factor Receptor 2 positive (HER2+) breast cancer resistant to trastuzumab (Herceptin®), a widely used medicine for breast cancer patients who test positive for HER2. The publication provides a rationale for exploring Cyclacel’s orally available CDK inhibitors in this population of patients with breast cancer. | ||
| • | Presented preclinical results for two Cyclacel clinical compounds, sapacitabine and CY116, at the 102nd Annual Meeting of the American Association of Cancer Research in Orlando, Florida. |
First Quarter 2011 Financial Results
Product Revenue
Revenues for the quarter were $0.2 million, compared to $0.3 million for the same period in 2010.
Cyclacel’s product revenues were comprised of sales of Xclair® Cream for radiation dermatitis and
Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia.
| 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 |
www.cyclacel.com — info@cyclacel.com
Research and Development Expenses
Research and development expenses in the first quarter of 2011 were $3.1 million compared to $2.2
million for the same period in 2010. The increase in costs of $0.9 million is primarily due to
$1.6 million of contractual expenses, resulting from the achievement of a milestone triggered by the
opening of enrollment in our SEAMLESS trial, pursuant to the Daiichi-Sankyo license under which
Cyclacel licenses certain patent rights for sapacitabine. This cost was partially offset by
reductions of $0.4 million in stock-based and other employee related compensation.
Selling, General and Administrative Expenses
Total selling, general and administrative expenses for the first quarter of 2011 were $1.8 million,
compared to $2.4 million for the same period in 2010 with the $0.6 million decrease primarily
related to professional and consultancy costs.
Cash and Cash Equivalents
As of March 31, 2011, Cyclacel’s cash and cash equivalents were $25.4 million compared to $29.5
million as of December 31, 2010. The Company expects that its cash resources are sufficient to meet
anticipated short-term working capital needs and fund on-going sapacitabine clinical trials for at
least the next twelve months.
Cyclacel’s Goals for 2011
| • | Present pilot study data of sapacitabine in combination with decitabine in patients with AML; | |
| • | Present additional sapacitabine data in hematological malignancies both as a single agent and in combination with other anticancer agents; | |
| • | Report Data Safety Monitoring Board (DSMB) review of safety data from the SEAMLESS Phase 3 AML study; | |
| • | Report top line Phase 2 sapacitabine data in NSCLC; and | |
| • | Report patient biomarker analysis from the APPRAISE Phase 2b randomized discontinuation study of seliciclib in patients with NSCLC. |
Conference call and Webcast Information:
Cyclacel will conduct a conference call on May 12, 2011 at 4:30 p.m. Eastern Time to review the
first quarter results. Conference call and webcast details are as follows:
Conference call information:
US/Canada call: (877) 493-9121/ international call: (973) 582-2750
US/Canada archive: (800) 642-1687 / international archive: (706) 645-9291
Code for live and archived conference call is 66220600
US/Canada call: (877) 493-9121/ international call: (973) 582-2750
US/Canada archive: (800) 642-1687 / international archive: (706) 645-9291
Code for live and archived conference call is 66220600
For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel
website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7
days.
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About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company developing oral therapies that target the various phases of
cell cycle control for the treatment of cancer and other serious diseases. Sapacitabine (CYC682),
a cell cycle modulating nucleoside analog, is in Phase 3 development for the treatment of acute
myeloid leukemia in the elderly under a
Special Protocol Assessment agreement with the U.S. Food and Drug Administration, and in Phase 2
studies for myelodysplastic syndromes and lung cancer. Seliciclib (CYC202 or R-roscovitine), a CDK
(cyclin dependent kinase) inhibitor, is in Phase 2 studies for the treatment of lung cancer and
nasopharyngeal cancer and in a Phase 1 trial in combination with sapacitabine. Cyclacel’s ALIGN
Pharmaceuticals subsidiary markets directly in the U.S. Xclair® Cream for radiation dermatitis,
Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia. Cyclacel’s 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. Please visit
www.cyclacel.com for additional information.
Forward-looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties
that could cause actual results to be materially different from historical results or from any
future results expressed or implied by such forward-looking statements. Such forward-looking
statements include statements regarding, among other things, the efficacy, safety, and intended
utilization of Cyclacel’s product candidates, the conduct and results of future clinical trials,
plans regarding regulatory filings, future research and clinical trials and plans regarding
partnering activities. Factors that may cause actual results to differ materially include the risk
that product candidates that appeared promising in early research and clinical trials do not
demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have
difficulty enrolling, Cyclacel may not obtain approval to market its products, the risks associated
with reliance on outside financing to meet capital requirements, and the risks associated with
reliance on collaborative partners for further clinical trials, development and commercialization
of product candidates. You are urged to consider statements that include the words “may,” “will,”
“would,” “could,” “should,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,”
“anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those
words or other comparable words to be uncertain and forward-looking. For a further list and
description of the risks and uncertainties the Company faces, please refer to our most recent
Annual Report on Form 10-K and other periodic and current filings that have been filed with the
Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking
statements are current only as of the date they are made, and we assume no obligation to update any
forward-looking statements, whether as a result of new information, future events or otherwise.
Contact for Cyclacel Pharmaceuticals, Inc.
Investors/Media: Corey Sohmer, (908) 517-7330, csohmer@cyclacel.com
© Copyright 2011 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and
Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn® and Xclair® are trademarks of
Sinclair Pharma plc. Herceptin® is a trademark of Genentech, Inc.
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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 | (inception) to | |||||||||||
| March 31, | March 31, | |||||||||||
| 2010 | 2011 | 2011 | ||||||||||
Revenues: |
||||||||||||
Collaboration and research and development revenue |
$ | — | $ | — | $ | 3,100 | ||||||
Product revenue |
254 | 192 | 2,514 | |||||||||
Grant revenue |
17 | — | 3,648 | |||||||||
| 271 | 192 | 9,262 | ||||||||||
Operating expenses: |
||||||||||||
Cost of goods sold |
142 | 106 | 1,498 | |||||||||
Research and development |
2,178 | 3,080 | 179,673 | |||||||||
Selling, general and administrative |
2,402 | 1,806 | 83,772 | |||||||||
Goodwill and intangible impairment |
— | — | 7,934 | |||||||||
Restructuring costs |
— | — | 2,634 | |||||||||
Total operating expenses |
4,722 | 4,992 | 275,511 | |||||||||
Operating loss |
(4,451 | ) | (4,800 | ) | (266,249 | ) | ||||||
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 |
(789 | ) | 78 | 6,104 | ||||||||
Foreign exchange (losses)/gains |
11 | (68 | ) | (4,323 | ) | |||||||
Interest income |
9 | 11 | 13,691 | |||||||||
Interest expense |
(24 | ) | — | (4,677 | ) | |||||||
Total other income (expense) |
(793 | ) | 21 | 5,285 | ||||||||
Loss before taxes |
(5,244 | ) | (4,779 | ) | (260,964 | ) | ||||||
Income tax benefit |
133 | 191 | 18,070 | |||||||||
Net loss |
(5,111 | ) | (4,588 | ) | (242,894 | ) | ||||||
Dividends on preferred ordinary shares |
— | — | (38,123 | ) | ||||||||
Deemed dividend on convertible exchangeable
preferred shares |
(419 | ) | — | (3,515 | ) | |||||||
Dividend on convertible exchangeable preferred shares |
(289 | ) | (182 | ) | (3,111 | ) | ||||||
Net loss applicable to common shareholders |
$ | (5,819 | ) | $ | (4,770 | ) | $ | (287,643 | ) | |||
Net loss per share — Basic and diluted |
$ | (0.18 | ) | $ | (0.10 | ) | ||||||
Weighted average common shares outstanding |
31,721,822 | 46,572,180 | ||||||||||
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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, | March 31, | |||||||
| 2010 | 2011 | |||||||
| (Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 29,495 | $ | 25,350 | ||||
Inventory |
174 | 115 | ||||||
Prepaid expenses and other current assets |
1,382 | 1,401 | ||||||
Total current assets |
31,051 | 26,866 | ||||||
Property, plant and equipment (net) |
408 | 331 | ||||||
Deposits and other assets |
— | — | ||||||
Total assets |
$ | 31,459 | $ | 27,197 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,723 | $ | 947 | ||||
Accrued liabilities and other current liabilities |
4,132 | 5,264 | ||||||
Warrant liability |
680 | 602 | ||||||
Total current liabilities |
6,535 | 6,813 | ||||||
Total liabilities |
6,535 | 6,813 | ||||||
Stockholders’ equity: |
||||||||
Preferred stock, $0.001 par value; 5,000,000 shares
authorized at December 31, 2010 and March 31, 2011;
1,213,142 shares issued and outstanding at December
31, 2010 and March 31, 2011. Aggregate preference
in liquidation of $13,344,562 (including undeclared
cumulative dividends) at December 31, 2010 and
March 31, 2011 |
1 | 1 | ||||||
Common stock, $0.001 par value; 100,000,000 shares
authorized at December 31, 2010 and March 31, 2011;
46,564,914 and 46,577,860 shares issued and
outstanding at December 31, 2010 and March 31, 2011 |
47 | 47 | ||||||
Additional paid-in capital |
266,666 | 266,737 | ||||||
Accumulated other comprehensive loss |
31 | 8 | ||||||
Deficit accumulated during the development stage |
(241,821 | ) | (246,409 | ) | ||||
Total stockholders’ equity |
24,924 | 20,384 | ||||||
Total liabilities and stockholders’ equity |
$ | 31,459 | $ | 27,197 | ||||
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