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): August 5, 2010
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, New Jersey |
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., dated
August 5, 2010, announcing certain financial results for the second quarter ended June 30, 2010.
The Company will conduct a conference call to review its financial results on Thursday, August
5, 2010, at 4:30 p.m., Eastern Time.
Item 9.01 Financial Statements and Exhibits.
(d) The following exhibit is furnished with this Report:
| Exhibit No. | Description | |||
| 99.1 | Press Release dated August 5, 2010. |
|||
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: August 5, 2010
Exhibit 99.1
|
Cyclacel Pharmaceuticals, Inc. |
PRESS RELEASE
CYCLACEL PHARMACEUTICALS REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS
BERKELEY HEIGHTS, NJ — August 5, 2010 — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ:
CYCCP), 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 second quarter of 2010.
Total operating expenses for the quarter and six months ended June 30, 2010 decreased to $4.5
million and $9.2 million, respectively, versus $5.5 million and $11.0 million, respectively, for
the same periods in 2009. Cyclacel reported a net loss of $6.5 million, or $0.18 per diluted share
for the second quarter of 2010, compared to a net loss of $7.4 million, or $0.36 per diluted share,
for the same period in 2009. For the six months ended June 30, 2010, Cyclacel reported a net loss
of $12.4 million, or $0.36 per diluted share, compared to a net loss of $12.7 million, or $0.62 per
diluted share in the same period in 2009. Cyclacel’s financial results for the second quarter of
2010 included a non-cash charge of $2.5 million related to the deemed dividend on the exchange of
preferred stock to common stock that occurred during the second quarter. Cyclacel’s financial
results for the second quarter of 2009 included a non-operating expense of $1.7 million related to
payments due as a consequence of the headcount reductions implemented in 2009.
“We are in ongoing dialogue with the Food and Drug Administration (FDA) regarding our Special
Protocol Assessment (SPA) request for a randomized, registration-directed, Phase 3 study of
sapacitabine in elderly patients with acute myeloid leukemia (AML),” said Spiro Rombotis, President
and Chief Executive Officer of Cyclacel. “Following the FDA’s acceptance that our proposed primary
endpoint of overall survival and key design components of our Phase 3 study are eligible for SPA,
we have been preparing to initiate the study, subject to FDA action on the SPA, including
contacting prospective investigators. We are also excited about the FDA’s grant of orphan
designation for sapacitabine for both AML and myelodysplastic syndromes (MDS). In addition we
presented at ASCO interim Phase 2 data in patients with MDS which demonstrated that sapacitabine
is active in patients refractory to hypomethylating agents. We look forward to reporting top line
results from the APPRAISE non-small cell lung cancer (NSCLC) Phase 2b trial with seliciclib and
also interim NSCLC Phase 2 data with sapacitabine.”
Business Highlights
| • | Granted orphan designation by the FDA for sapacitabine for the treatment of both AML and MDS; | ||
| • | Presented interim results from a Phase 2 trial of sapacitabine in older patients with MDS at ASCO demonstrating clinical activity in patients refractory to hypomethylating agents; | ||
| • | Six presentations at AACR Annual Meeting highlighted Cyclacel’s innovative and diverse oncology targeted pipeline including data on CYC065, a second-generation CDK inhibitor, with activity against drug-resistant cancers; and | ||
| • | Cyclacel added to Russell Microcap® Index. |
Product Revenue
Cyclacel’s product revenues were comprised of sales of Xclair® Cream for radiation dermatitis and
Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia. Product revenues for the quarter and six
months ended June 30, 2010 were $0.1 million and $0.3 million, respectively, compared to $0.2
million and $0.5 million, respectively, for the same periods in 2009. Product revenues for the
second quarter were negatively impacted by return of expiring product with a two-year shelf-life.
Our supplier has recently increased product shelf life to three years.
Selling, General and Administrative Expenses
Total selling, general and administrative expenses for the second quarter of 2010 increased to $3.1
million as compared to $2.3 million for the second quarter of 2009. For the six months ended June
30, 2010 total selling, general and administrative expenses were $5.5 million versus $4.5 million
for the same period in 2009. The increase in selling, general and administrative expenses was
primarily due to increased spending on professional and consultancy costs.
Research and Development Expenses
Cyclacel’s research and development expenses for the second quarter of 2010 decreased to $1.3
million as compared to $2.7 million for the same period in 2009. For the six months ended June 30,
2010 research and development expenses were $3.5 million as compared to $5.8 million for the same
period in 2009. The $1.4 million decrease in research and development expenses was primarily
associated with the Company’s lower cost base following headcount reductions in 2008 and 2009 and
the concentration of resources on sapacitabine, Cyclacel’s lead drug candidate.
Cash and Cash Equivalents
As of June 30, 2010, Cyclacel’s cash and cash equivalents were $19.5 million compared to $11.5
million as of December 31, 2009. The Company expects its existing capital resources should be
adequate to fund operations and current commitments into 2012.
Upcoming Milestones
| • | FDA action regarding the SPA for the Phase 3 study of sapacitabine in elderly patients with AML; | ||
| • | Initiation of Phase 3 study of sapacitabine in elderly patients with AML; | ||
| • | Report NSCLC interim Phase 2 data with sapacitabine; and | ||
| • | Report top line results from APPRAISE NSCLC Phase 2b trial with seliciclib. |
Conference call and Webcast Information:
Cyclacel management will review second quarter 2010 financial and business highlights on a
conference call scheduled for today at 4:30 p.m. Eastern. Conference call and webcast details are
as follows:
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 91437070.
US/Canada archive: (800) 642-1687 / international archive: (706) 645-9291
Code for live and archived conference call is 91437070.
Webcast: 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 disorders. Three product
candidates are in clinical development: Sapacitabine (CYC682), a cell cycle modulating nucleoside
analog, is in Phase 2 studies for the treatment of acute myeloid leukemia in the elderly,
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. CYC116, an Aurora
kinase and VEGFR2 inhibitor, is in a Phase 1 trial in patients with solid tumors. 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, the risk that Cyclacel
will 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
Corey Sohmer, (908) 517-7330
csohmer@cyclacel.com
© Copyright 2010 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.
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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 | ||||||||||||||||||||
| For the three | For the six | (inception) | ||||||||||||||||||
| months ended | months ended | to | ||||||||||||||||||
| June 30, | June 30, | June 30, | ||||||||||||||||||
| 2009 | 2010 | 2009 | 2010 | 2010 | ||||||||||||||||
| (Restated) | (Restated) | (Restated) | ||||||||||||||||||
Revenues: |
||||||||||||||||||||
Collaboration and research and
development revenue |
— | 100 | — | 100 | 3,100 | |||||||||||||||
Product revenue |
249 | 19 | 465 | 273 | 2,021 | |||||||||||||||
Grant revenue |
17 | — | 29 | 16 | 3,652 | |||||||||||||||
| 266 | 119 | 494 | 389 | 8,773 | ||||||||||||||||
Operating expenses: |
||||||||||||||||||||
Cost of goods sold |
192 | 92 | 308 | 234 | 1,208 | |||||||||||||||
Research and development |
2,683 | 1,322 | 5,780 | 3,497 | 173,676 | |||||||||||||||
General and administrative |
2,285 | 3,091 | 4,515 | 5,491 | 77,337 | |||||||||||||||
Goodwill and intangibles impairment |
— | — | — | — | 7,934 | |||||||||||||||
Restructuring costs |
366 | — | 366 | — | 2,634 | |||||||||||||||
Total operating expenses |
5,526 | 4,505 | 10,969 | 9,222 | 262,789 | |||||||||||||||
Operating loss |
(5,260 | ) | (4,386 | ) | (10,475 | ) | (8,833 | ) | (254,016 | ) | ||||||||||
Other income (expense): |
||||||||||||||||||||
Costs associated with aborted 2004 IPO |
— | — | — | — | (3,550 | ) | ||||||||||||||
Payment under guarantee |
(1,652 | ) | — | (1,652 | ) | — | (1,652 | ) | ||||||||||||
Change in valuation of derivative |
— | — | — | — | (308 | ) | ||||||||||||||
Change in valuation of warrants |
(288 | ) | 273 | (296 | ) | (516 | ) | 5,848 | ||||||||||||
Foreign exchange gains/(losses) |
(111 | ) | (49 | ) | (248 | ) | (38 | ) | (4,225 | ) | ||||||||||
Interest income |
12 | 8 | 92 | 17 | 13,660 | |||||||||||||||
Interest expense |
21 | (9 | ) | (120 | ) | (33 | ) | (4,667 | ) | |||||||||||
Total other income (expense) |
(2,018 | ) | 223 | (2,224 | ) | (570 | ) | 5,106 | ||||||||||||
Loss before taxes |
(7,278 | ) | (4,163 | ) | (12,699 | ) | (9,403 | ) | (248,910 | ) | ||||||||||
Income tax benefit |
233 | 230 | 591 | 363 | 17,585 | |||||||||||||||
Net loss |
(7,045 | ) | (3,933 | ) | (12,108 | ) | (9,040 | ) | (231,325 | ) | ||||||||||
Dividends on preferred ordinary shares |
— | — | — | — | (38,123 | ) | ||||||||||||||
Deemed dividend on convertible
exchangeable preferred shares |
— | (2,496 | ) | — | (2,915 | ) | (2,915 | ) | ||||||||||||
Dividend on convertible exchangeable share |
(307 | ) | (114 | ) | (614 | ) | (403 | ) | (2,960 | ) | ||||||||||
Net loss applicable to common shareholders |
(7,352 | ) | (6,543 | ) | (12,722 | ) | (12,358 | ) | (275,323 | ) | ||||||||||
Net loss per share — basic and diluted |
$ | (0.36 | ) | $ | (0.18 | ) | $ | (0.62 | ) | $ | (0.36 | ) | ||||||||
Weighted average common shares outstanding |
20,433,129 | 36,565,972 | 20,433,129 | 34,157,279 | ||||||||||||||||
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CYCLACEL PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s)
(A Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s)
| December 31, | June 30, | |||||||
| 2009 | 2010 | |||||||
| (Unaudited) | ||||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
11,493 | 19,543 | ||||||
Inventory |
145 | 39 | ||||||
Prepaid expenses and other current assets |
1,731 | 1,925 | ||||||
Total current assets |
13,369 | 21,507 | ||||||
Property, plant and equipment (net) |
901 | 606 | ||||||
Deposits and other assets |
196 | 196 | ||||||
Total assets |
14,466 | 22,309 | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
1,709 | 1,550 | ||||||
Accrued liabilities and other current liabilities |
6,709 | 5,255 | ||||||
Warrants liability |
342 | 858 | ||||||
Other accrued restructuring charges |
1,062 | 492 | ||||||
Total liabilities |
9,822 | 8,155 | ||||||
Stockholders’ equity |
4,644 | 14,154 | ||||||
Total liabilities and stockholders’ equity |
14,466 | 22,309 | ||||||
SOURCE: Cyclacel Pharmaceuticals, Inc.
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