8-K
UNITED STATES
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
Date of Report (Date of earliest
event reported): November 3, 2009
CYCLACEL PHARMACEUTICALS,
INC.
(Exact name of registrant as
specified in its charter)
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Delaware |
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0-50626 |
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91-1707622 |
(State or other Jurisdiction of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
|
|
|
200 Connell Drive, Suite 1500
Berkeley Heights, New Jersey
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|
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))
1
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 November 3, 2009, announcing certain financial results for the
quarter ended September 30, 2009.
The Company will
conduct a conference call to review its financial results on Tuesday,
November 3, 2009, at 4:30 p.m., Eastern Time.
Item 9.01 |
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Financial Statements and Exhibits
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(d) |
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The following exhibit is furnished with this
Report:
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Exhibit No. |
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Description |
99.1
|
|
Press Release dated November 3, 2009 |
2
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: November 3, 2009
3
EXHIBIT INDEX
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Exhibit No. |
|
Description |
99.1
|
|
Press Release dated November 3, 2009 |
4
Exhibit 99.1
Exhibit 99.1
CYCLACEL PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2009
FINANCIAL RESULTS
Conference Call Scheduled Tuesday, November 3 at 4:30 p.m. Eastern
Berkeley Heights, NJ, November 3, 2009 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ:
CYCCP; Cyclacel or the Company) announced today financial and operating results for the third
quarter of 2009. The Companys net loss for the quarter was $3.1 million or $0.13 per share. This
compared to a net loss of $17.6 million or $0.86 loss per share for the same period in 2008. As of
September 30, 2009, the Company had $14.4 million in cash and cash equivalents.
Our recent achievement of 30% one-year survival in two of the three randomized schedules of the
Phase 2 study of sapacitabine as a treatment for elderly patients aged 70 and older with acute
myeloid leukemia (AML) provides a strong rationale supporting the continued development of this
novel agent, said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. We are
working with the FDA to design a registration study for sapacitabine in hematological malignancies.
We continue to concentrate our efforts on advancing sapacitabine into Phase 3 development for AML
and/or myelodysplastic syndromes (MDS) while preserving cash for the next twelve months. We are
also looking forward to reporting in 2010 data from our ongoing Phase 2 studies of sapacitabine and
seliciclib in lung cancer.
Recent Highlights:
|
|
Reported 30% one-year survival from the Phase 2 sapacitabine trial in elderly patients with
AML aged 70 and older in two out of three randomized schedules; |
|
|
Type A meeting granted by the FDA in the 4th quarter of 2009 to discuss the design of Phase
3 registration studies in AML and/or MDS; |
|
|
Phase 3 study designs to be included in an upcoming submission requesting a Special
Protocol Assessment or SPA; |
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Raised $3.4 million in gross proceeds in a registered direct offering in July. |
Key Financials:
Total revenues for the third quarter of 2009 were $0.2 million representing a decrease of 14%
compared to $0.3 million for the same period in 2008. These revenues were mainly attributable to
sales of the Xclair® and Numoisyn® products.
Total research and development (R&D) expenses in the third quarter of 2009 were $1.4 million, a 65%
decrease as compared to $4.0 million in the third quarter of 2008. $1.6 million of the overall
decrease was associated with the discontinuation of the Companys preclinical programs from the
cost-containment measures implemented in September 2008 and June 2009. The Company recognized cost
reductions of approximately $1.0 million in the third quarter 2009 as compared to the same period
in 2008 due to the completion of patient enrollment in the APPRAISE trial in the third quarter of
2008.
Total selling, general and administrative expenses (SG&A) for the third quarter of 2009 were $2.2
million, a 32% decrease as compared to $3.2 million in the third quarter of 2008. The reduction in
operating expenses in the third quarter of 2009 compared to the same period in 2008 is primarily
attributable to the cost-containment measures implemented in September 2008 and June 2009 and the
concentration of the Companys resources on the clinical development of sapacitabine.
Other operating expenses in the third quarter of 2008 also included a non-cash charge of $6.8
million for goodwill and intangibles impairment in respect of the acquisitions of Xcyte Therapies,
Inc. and ALIGN following Cyclacels annual test for impairment and restructuring costs.
Other income (expense) showed income of $0.2 million in the third quarter of 2009 as compared to
expense of $4.1 million in the third quarter of 2008. The decrease in expense was primarily due to
an unrealized foreign exchange loss of $4.8 million in the third quarter of 2008 compared to a $0.1
million foreign exchange gain in the same period in 2009 arising from intercompany loans with our
wholly-owned subsidiaries due to the translation effects of the US dollar against the British pound
together with a change in the valuation of warrants and a reduction in interest income earned.
The net loss in the third quarter of 2009 was $3.1 million or $0.13 per share as compared to $17.6
million in the third quarter of 2008 or $0.86 per share.
Cyclacel also reported results of its operations for the nine months ended September 30, 2009.
Total revenues for the nine months ended September 30, 2009 were $0.7 million representing an
increase of 16% compared to $0.6 million for the same period in 2008. These revenues were mainly
attributable to sales of the Xclair® and Numoisyn® products.
For the nine months ended September 30, 2009, R&D expenses were $7.2 million, a 54% decrease as
compared to $15.7 million in the comparable period in 2008.
For the nine months ended September 30, 2009, SG&A expenses were $6.7 million, a 41% decrease as
compared to $11.3 million in the comparable period in 2008.
The reduction in operating expenses in 2009 compared to 2008 is primarily attributable to the
cost-containment measures implemented in September 2008 and June 2009 and the concentration of the
Companys resources on the clinical development of sapacitabine.
Other operating expenses for the nine months ended September 30 2008 also included a non-cash
charge of $6.8 million for goodwill and intangibles impairment in respect of the acquisitions of
Xcyte and ALIGN and restructuring costs. For the nine months ended September 30, 2009, the Company
recorded restructuring costs of $0.4 million.
Other income (expense) for the nine months ended September 30, 2009 showed an expense of $2.0
million as compared to $0.4 million for the same period in 2008. The 2009 loss included a
non-operating expense of $1.7 million related to payments due under an agreement with Scottish
Enterprise as a consequence of the headcount reductions implemented by the Company. During 2008,
the Company recorded a charge of $3.3 million associated with the warrant derivative as compared to
income of $0.2 million in 2009 as a result of the Companys common stock price at each quarter end.
The decrease in expense was primarily due to unrealized foreign exchange loss of $4.6 million in
the nine months ended September 30, 2008 compared to $0.1 million foreign exchange loss in the same
period in 2009 arising mostly from intercompany loans with our wholly-owned subsidiaries due to the
translation effects of the US dollar against the British pound.
For the nine months ended September 30, 2009, the Company reported a net loss of $15.2 million or
$0.71 per share, compared to a net loss for the same period in 2008 of $32.4 million or $1.59 per
share.
Conference call and Webcast Information:
Cyclacel management will conduct a conference call on November 3, 2009 at 4:30 p.m. Eastern Time to
review the quarterly 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 37927625
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.
2
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a diversified biopharmaceutical company dedicated to the discovery, development and
commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious
disorders. Sapacitabine, 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 and
in Phase 1 in combination with seliciclib. Seliciclib, a CDK (cyclin dependent kinase) inhibitor,
is in Phase 2 for the treatment of lung and nasopharyngeal cancer. CYC116, an Aurora kinase and
VEGFR2 inhibitor, is in Phase 1 in patients with solid tumors. Cyclacels ALIGN Pharmaceuticals
subsidiary markets directly in the U.S. Xclair® Cream for radiation dermatitis, Numoisyn® Liquid
and Numoisyn® Lozenges for xerostomia. Cyclacels strategy is to build a diversified
biopharmaceutical business focused in hematology and oncology based on a portfolio of commercial
products and a development pipeline of novel drug candidates. Please visit www.cyclacel.com
for additional information.
Risk factors
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 Cyclacels 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. These factors and others are more fully discussed under
Risk Factors in the Annual Report on Form 10-K for the year ended December 31, 2008, as
supplemented by the interim quarterly reports, filed with the SEC.
Contacts for Cyclacel Pharmaceuticals, Inc.
Investors/Media:
Corey Sohmer, (908) 517-7330
csohmer@cyclacel.com
© Copyright 2009 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.
3
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
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Period from |
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For the three |
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For the nine |
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August 13, 1996 |
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months ended |
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months ended |
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(inception) to |
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September 30, |
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September 30, |
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September 30, |
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2008 |
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2009 |
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2008 |
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2009 |
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2009 |
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($000s) |
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Revenues: |
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Collaboration and research and
development revenue |
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3,000 |
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Product revenue |
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257 |
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|
223 |
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|
590 |
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|
688 |
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1,526 |
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Grant revenue |
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12 |
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7 |
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36 |
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|
|
36 |
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3,671 |
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|
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269 |
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|
230 |
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|
626 |
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|
724 |
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8,197 |
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|
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Operating expenses: |
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|
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|
|
|
|
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Cost of goods sold |
|
|
120 |
|
|
|
163 |
|
|
|
315 |
|
|
|
472 |
|
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|
901 |
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Research and development |
|
|
4,030 |
|
|
|
1,394 |
|
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15,718 |
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7,174 |
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167,587 |
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General and administrative |
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3,218 |
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2,188 |
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11,337 |
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6,703 |
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70,011 |
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Goodwill and intangibles impairment |
|
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6,344 |
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|
|
|
|
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6,344 |
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7,934 |
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Restructuring costs |
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|
489 |
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489 |
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366 |
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2,634 |
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Total operating expenses |
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14,201 |
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3,745 |
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34,203 |
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14,715 |
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249,067 |
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Operating loss |
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|
(13,932 |
) |
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|
(3,515 |
) |
|
|
(33,577 |
) |
|
|
(13,991 |
) |
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|
(240,870 |
) |
Other income (expense): |
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|
|
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|
|
|
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|
|
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Costs associated with aborted 2004 IPO |
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|
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(3,550 |
) |
Payment under guarantee |
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|
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(1,652 |
) |
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(1,652 |
) |
Change in valuation of derivative |
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(308 |
) |
Change in valuation of warrants |
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|
432 |
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|
|
101 |
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3,321 |
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|
|
(195 |
) |
|
|
6,512 |
|
Foreign exchange gains/(losses) |
|
|
(4,776 |
) |
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|
119 |
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|
|
(4,638 |
) |
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|
(129 |
) |
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|
(4,172 |
) |
Interest income |
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|
287 |
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|
7 |
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1,184 |
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|
94 |
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13,635 |
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Interest expense |
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|
(69 |
) |
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|
(41 |
) |
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|
(244 |
) |
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|
(156 |
) |
|
|
(4,613 |
) |
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Total other income (expense) |
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(4,126 |
) |
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186 |
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(377 |
) |
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|
(2,038 |
) |
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5,852 |
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Loss before taxes |
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|
(18,058 |
) |
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|
(3,329 |
) |
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|
(33,954 |
) |
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|
(16,029 |
) |
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|
(235,018 |
) |
Income tax benefit |
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|
411 |
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|
205 |
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|
1,511 |
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|
796 |
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17,070 |
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Net loss |
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|
(17,647 |
) |
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|
(3,124 |
) |
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(32,443 |
) |
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|
(15,233 |
) |
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|
(217,948 |
) |
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Dividends on Preferred Ordinary shares |
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(38,123 |
) |
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Net loss applicable to common
shareholders |
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|
(17,647 |
) |
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|
(3,124 |
) |
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|
(32,443 |
) |
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|
(15,233 |
) |
|
|
(256,071 |
) |
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Net loss per share basic and diluted |
|
$ |
(0.86 |
) |
|
$ |
(0.13 |
) |
|
$ |
(1.59 |
) |
|
$ |
(0.71 |
) |
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Weighted average shares |
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|
20,433,129 |
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|
|
23,172,259 |
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|
|
20,433,129 |
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|
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21,356,206 |
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4
CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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As of |
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As of |
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|
December 31 |
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September 30 |
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|
2008 |
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|
2009 |
|
ASSETS |
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Current assets: |
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|
|
|
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Cash and cash equivalents |
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|
24,220 |
|
|
|
14,433 |
|
Short-term investments |
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|
1,502 |
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Inventory |
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|
508 |
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|
|
140 |
|
Prepaid expenses and other current assets |
|
|
2,784 |
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|
|
1,652 |
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|
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Total current assets |
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|
29,014 |
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|
|
16,225 |
|
Property, plant and equipment (net) |
|
|
1,748 |
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|
|
1,121 |
|
Deposits and other assets |
|
|
195 |
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|
|
196 |
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|
|
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|
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Total assets |
|
|
30,957 |
|
|
|
17,542 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
754 |
|
|
|
1,463 |
|
Accrued liabilities |
|
|
5,186 |
|
|
|
5,228 |
|
Other current liabilities |
|
|
1,615 |
|
|
|
1,336 |
|
Warrants liability |
|
|
43 |
|
|
|
238 |
|
Current portion of other accrued restructuring charges |
|
|
1,029 |
|
|
|
1,063 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
8,627 |
|
|
|
9,328 |
|
Other accrued restructuring charges, net of current |
|
|
1,062 |
|
|
|
267 |
|
Other long term payables |
|
|
626 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
10,315 |
|
|
|
9,595 |
|
|
|
|
|
|
|
|
Commitments and contingencies |
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Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares
authorized at December 31, 2008 and September 30,
2009, respectively; 2,046,813 shares issued and
outstanding at December 31, 2008 and September 30,
2009, respectively
Aggregate preference in liquidation of $20,673,000 at
December 31, 2008 and September 30, 2009 |
|
|
2 |
|
|
|
2 |
|
Common stock, $0.001 par value; 100,000,000 shares
authorized at December 31, 2008 and September 30,
2009; 20,433,129, and 24,433,129 shares issued and
outstanding at December 31, 2008 and September 30,
2009, respectively |
|
|
20 |
|
|
|
24 |
|
Additional paid in capital |
|
|
223,377 |
|
|
|
225,864 |
|
Accumulated other comprehensive loss |
|
|
(42 |
) |
|
|
5 |
|
Deficit accumulated during the development stage |
|
|
(202,715 |
) |
|
|
(217,948 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
20,642 |
|
|
|
7,947 |
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
|
30,957 |
|
|
|
17,542 |
|
|
|
|
|
|
|
|
SOURCE: Cyclacel Pharmaceuticals, Inc.
5