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): November 14, 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 November 14, 2011, announcing certain financial results for the third quarter
ended September 30, 2011.
The Company will conduct a conference call to review its financial results on Monday, November
14, 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 third quarter ended September
30, 2011, dated November 14, 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: November 14, 2011
Exhibit 99.1
|
Cyclacel Pharmaceuticals, Inc. |
PRESS RELEASE
CYCLACEL PHARMACEUTICALS REPORTS THIRD QUARTER 2011 FINANCIAL RESULTS
— SEAMLESS Phase 3 trial design simplified; FDA confirmed that SPA remains valid —
— Conference Call Scheduled November 14, 2011 at 4:30 p.m. Eastern Time —
Berkeley Heights, NJ, November 14, 2011 — Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ:
CYCCP; Cyclacel or the Company), announced today its financial results and business highlights for
the third quarter of 2011. The Company’s net loss applicable to common shareholders for the third
quarter of 2011 was $3.6 million, or $0.07 per basic and diluted share, compared to a net loss
applicable to common shareholders of $4.0 million or $0.11 per basic and diluted share, for the
third quarter of 2010. For the nine months ended September 30, 2011, the Company reported a net
loss applicable to common shareholders of $12.1 million, or $0.25 per basic and diluted share,
compared to a net loss of $16.3 million, or $0.47 per basic and diluted share, for the nine months
ended September 30, 2010.
The Company also announced that it has implemented a simplification in the design of the on-going
SEAMLESS Phase 3 study of sapacitabine as front-line treatment in elderly patients with Acute
Myeloid Leukemia (AML) converting it into a 2-arm from the original 3-arm design, following the
recent recommendation by the SEAMLESS Data Safety Monitoring Board, or DSMB, to continue SEAMLESS.
The 2-arm design compares sapacitabine dosed sequentially with decitabine versus decitabine alone.
Cyclacel has received written confirmation from the US Food and Drug Administration (FDA) that,
following the modification in the trial design, the previously agreed Special Protocol Assessment
(SPA) agreement remains valid.
“The original 3-arm design of SEAMLESS was based on the information available at that time,” said
Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “Since then the safety and
efficacy data from the pilot Phase 1/2 study have encouraged us to amend the protocol into a 2-arm
design, comparing the regimen of sapacitabine dosed sequentially with decitabine versus decitabine
alone. The objective of the amendment is to increase the chance of detecting an improvement in
survival while staying within our existing budget and forecasted time frame. We have been
encouraged by the pace of early enrollment of patients and investigator interest in SEAMLESS. We
are looking forward to achieving our patient enrollment targets in SEAMLESS as our highest
priority.”
Design Details of SEAMLESS Phase 3 study in AML
SEAMLESS is a registration-directed Phase 3 study of sapacitabine as front-line treatment in
patients with newly diagnosed AML de novo or AML preceded by antecedent hematological disorder who
were not treated with hypomethylating agents, aged 70 years or older, who are not candidates for or
have refused intensive induction chemotherapy. The study will enroll approximately 485 patients who
will be randomized 1:1 or about 243 patients into each of two arms: sapacitabine dosed sequentially
with decitabine versus decitabine alone. A prespecified interim analysis for futility will be
performed and reviewed by the DSMB when 212 deaths have occurred. The primary objective is to
detect with 90% power an improvement in overall survival at a statistical significance level of
p-value equal to or less than 0.05. The original 3-arm design required a statistical significance
level of p-value equal to or less than 0.025 for each of two pairwise comparisons. The secondary
objectives are to compare the response rates in terms of complete remission (CR), complete
remission with incomplete platelet recovery (CRp), partial response (PR), hematologic improvement
(HI), stable disease (SD) and their corresponding durations, transfusion requirements, number of
days in hospital, one-year survival and safety.
| 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
Business Highlights
| • | Data from the lead-in portion of the SEAMLESS Phase 3 trial of sapacitabine in elderly
patients with AML confirmed the safety and tolerability observed in the pilot Phase 1/2
study and met the criteria prespecified in the protocol and SPA to proceed to the
randomized stage of the study; |
| • | DSMB recommended continuation of the SEAMLESS Phase 3 trial of sapacitabine in elderly
patients with AML who are not eligible for intensive chemotherapy; |
| • | Amended SEAMLESS Phase 3 trial protocol to a 2-arm design: sapacitabine alternating with
decitabine versus decitabine; |
| • | Received written confirmation from FDA that the SPA agreement regarding SEAMLESS, which
was announced in September 2010, remains valid for the 2-arm design; |
| • | Commenced an investigator-initiated, Phase 2 trial of sapacitabine in combination with
cyclophosphamide and rituximab in patients with relapsed chronic lymphocytic leukemia (CLL)
or small lymphocytic lymphoma (SLL) hematological malignancies and 11q22-23 deletion at The
University of Texas MD Anderson Cancer Center; and |
| • | Raised net proceeds of $9.3 million in an underwritten registered direct offering. |
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 nine
months ended September 30, 2011 were $0.2 million and $0.5 million, respectively, compared to
approximately $0.2 million and $0.4 million, respectively, for the same periods in 2010.
Costs and Expenses
Total operating expenses remained the same at $4.2 million for the each of the three months ended
September 30, 2011 and 2010. For the nine months ended September 30, 2011, total operating
expenses were $13.2 million, which included a $1.6 million milestone payment to Daiichi-Sankyo, as
compared to $13.4 million for the same period in 2010.
Research and Development Expenses
Research and development expenses for the third quarter of 2011 increased to $2.1 million as
compared to $1.5 million for the same period in 2010. For the nine months ended September 30, 2011,
research and development expenses were $7.0 million as compared to $5.0 million for the same period
in 2010. The increase was primarily due to a $1.6 million milestone payment in the first quarter
payable to Daiichi-Sankyo as part of our contractual obligation resulting from sapacitabine’s entry
into Phase 3 trials and clinical trial costs related to SEAMLESS.
Selling, General and Administrative Expenses
Total selling, general and administrative expenses decreased by approximately $0.5 million from
$2.6 million for the third quarter of 2010 to $2.1 million for the third quarter of 2011. For the
nine months ended September 30, 2011 total selling, general and administrative expenses were $5.9
million as compared to $8.1 million for the same period in 2010. The decrease of $2.2 million in
expenses was primarily attributable to a net decrease in
professional and consultancy costs, the elimination of costs related to a facility lease that
expired in December 2010 and a decrease in compensation-related costs.
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Cash and Cash Equivalents
As of September 30, 2011, Cyclacel’s cash and cash equivalents were $27.7 million compared to $29.5
million as of December 31, 2010.
NASDAQ notification
Received notification from NASDAQ that the Company failed to comply with the minimum $1 bid price
requirement for continued listing set forth in Marketplace Rule 5450(a)(1).
Upcoming Milestones
| • | Presentation of updated sapacitabine data from the Phase 1/2 pilot study in elderly
patients with AML at the 2011 American Society of Hematology (ASH) annual meeting; |
| • | Report interim data from the Phase 2 study of sapacitabine in non-small cell lung cancer
(NSCLC); |
| • | Report interim data from the Phase 1 combination study of sapacitabine and seliciclib in
patients with solid tumors; 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 November 14, 2011 at 4:30 p.m., Eastern Time, to review
the third quarter and nine months ended September 30, 2011 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 call: (877) 493-9121/ international call: (973) 582-2750.
US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406.
Code for live and archived conference call is 25156473.
Code for live and archived conference call is 25156473.
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.
Analyst & Institutional Investor Meeting
The Company will hold an Analyst and Institutional Investor meeting on December 7, 2011 in New York
City. The meeting will include a discussion of treatment alternatives for elderly patients with
acute myeloid leukemia by an expert hematologist, the design of the SEAMLESS Phase 3 trial and a
discussion of the potential utility of sapacitabine in non-small cell lung cancer (NSCLC) by a
thoracic oncology expert. Details of the event will be provided in a forthcoming announcement.
About Acute Myeloid Leukemia (AML)
AML is a cancer of blood cells that progresses rapidly and if not treated, could be fatal in a few
months. AML is generally a disease of older people and is uncommon before the age of 40. The
average age of a patient with
AML is about 67 years. There are more than 12,300 new cases of AML, of which about half are
elderly, and nearly 9,000 deaths caused by this cancer each year in the United States. A recently
published review of The University of Texas MD Anderson Cancer Center’s historical experience with
front-line intensive induction chemotherapy for elderly AML patients aged 70 years or older
demonstrated that while 45% of patients achieved a complete remission, median overall survival was
only 4.6 months and 36% of patients died within the first 8 weeks of treatment, underscoring the
unmet need in this patient setting. Currently there are no therapies approved for use in elderly
AML patients not eligible for intensive chemotherapy.
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About Special Protocol Assessment (SPA)
A Special Protocol Assessment is a binding written agreement with the FDA that the sponsor’s
proposed trial protocol design, clinical endpoints and statistical analyses are acceptable to
support regulatory approval. Final marketing approval depends on efficacy results, adverse event
profile and an evaluation of the benefit/risk of a treatment as demonstrated in the trial. For
further information regarding the SPA process, please visit the FDA website, www.fda.gov.
About Sapacitabine
Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently being evaluated in the
SEAMLESS registration-directed, Phase 3 trial in front-line elderly acute myeloid leukemia (AML)
and Phase 2 trials in patients with hematological malignancies and solid tumors. Sapacitabine acts
through a dual mechanism, interfering with DNA synthesis by causing single-strand DNA breaks and
inducing arrest of cell cycle progression mainly at G2-Phase. Both sapacitabine and CNDAC, its
major metabolite, have demonstrated potent anti-tumor activity in preclinical studies. Over 300
patients have received sapacitabine in Phase 2 studies in AML, myelodysplastic syndromes (MDS),
cutaneous T cell lymphoma (CTCL) and non-small cell lung cancer (NSCLC). Sapacitabine has been
administered to approximately 170 patients in five Phase 1 studies with both hematological
malignancies and solid tumors. In June 2009 at the Annual Meeting of the American Society of
Hematology (ASH), Cyclacel reported data from a randomized, Phase 2, single-agent study of
sapacitabine including promising 1-year survival in elderly patients with AML aged 70 years or
older. In October 2011 the independent Data Safety Monitoring Board (DSMB) of SEAMLESS recommended
that the Phase 3 study should continue as planned. The U.S. FDA and the European Medicines Agency
have designated sapacitabine as an orphan drug for the treatment of both AML and MDS. Sapacitabine
is part of Cyclacel’s pipeline of small molecule drugs designed to target and stop uncontrolled
cell division.
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),
an orally-available, cell cycle modulating, nucleoside analogue, is in Phase 3 development for the
front-line treatment of acute myeloid leukemia in the elderly and Phase 2 studies for
myelodysplastic syndromes, lung cancer and chronic lymphocytic leukemia. Seliciclib (CYC202 or
R-roscovitine), an orally-available, 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.
4
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.
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CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Period from | ||||||||||||||||||||
| August 13, | ||||||||||||||||||||
| 1996 | ||||||||||||||||||||
| For the three | For the nine | (inception) to | ||||||||||||||||||
| months ended | months ended | December | ||||||||||||||||||
| September 30 | September 30 | 31, | ||||||||||||||||||
| 2010 | 2011 | 2010 | 2011 | 2010 | ||||||||||||||||
| ($000s) | ||||||||||||||||||||
Revenues: |
||||||||||||||||||||
Collaboration and research and development revenue |
— | — | 100 | — | 3,100 | |||||||||||||||
Product revenue |
159 | 164 | 432 | 524 | 2,846 | |||||||||||||||
Grant revenue |
— | — | 16 | — | 3,648 | |||||||||||||||
| 159 | 164 | 548 | 524 | 9,594 | ||||||||||||||||
Operating expenses: |
||||||||||||||||||||
Cost of goods sold |
76 | 95 | 310 | 273 | 1,665 | |||||||||||||||
Research and development |
1,469 | 2,066 | 4,968 | 7,005 | 183,598 | |||||||||||||||
General and administrative |
2,612 | 2,051 | 8,103 | 5,891 | 87,857 | |||||||||||||||
Goodwill and intangibles impairment |
— | — | — | — | 7,934 | |||||||||||||||
Restructuring costs |
— | — | — | — | 2,634 | |||||||||||||||
Total operating expenses |
4,157 | 4,212 | 13,381 | 13,169 | 283,688 | |||||||||||||||
Operating loss |
(3,998 | ) | (4,048 | ) | (12,833 | ) | (12,645 | ) | (274,094 | ) | ||||||||||
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 |
73 | 440 | (443 | ) | 643 | 6,713 | ||||||||||||||
Warrant re-pricing |
— | — | — | — | (44 | ) | ||||||||||||||
Foreign exchange gains/(losses) |
(25 | ) | 28 | (63 | ) | (59 | ) | (4,314 | ) | |||||||||||
Interest income |
7 | 9 | 24 | 33 | 13,713 | |||||||||||||||
Interest expense |
(7 | ) | — | (40 | ) | — | (4,677 | ) | ||||||||||||
Total other income (expense), net |
48 | 477 | (522 | ) | 617 | 5,881 | ||||||||||||||
Loss before taxes |
(3,950 | ) | (3,571 | ) | (13,355 | ) | (12,028 | ) | (268,213 | ) | ||||||||||
Income tax benefit |
143 | 126 | 506 | 443 | 18,322 | |||||||||||||||
Net loss |
(3,807 | ) | (3,445 | ) | (12,849 | ) | (11,585 | ) | (249,891 | ) | ||||||||||
Dividends on preferred ordinary shares |
— | — | — | — | (38,123 | ) | ||||||||||||||
Deemed dividend on convertible exchangeable preferred shares |
— | — | (2,915 | ) | — | (3,515 | ) | |||||||||||||
Dividend on convertible exchangeable preferred shares |
(182 | ) | (182 | ) | (585 | ) | (546 | ) | (3,475 | ) | ||||||||||
Net loss applicable to common stockholders |
(3,989 | ) | (3,627 | ) | (16,349 | ) | (12,131 | ) | (295,004 | ) | ||||||||||
Net loss per share — basic and diluted |
$ | (0.11 | ) | $ | (0.07 | ) | $ | (0.47 | ) | $ | (0.25 | ) | ||||||||
Weighted average common shares outstanding |
37,030,436 | 53,711,678 | 35,125,522 | 48,981,743 | ||||||||||||||||
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CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| As of | As of | |||||||
| December 31 | September 30 | |||||||
| 2010 | 2011 | |||||||
| ($000s) | ($000s) | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
29,495 | 27,675 | ||||||
Inventory |
174 | 165 | ||||||
Prepaid expenses and other current assets |
1,382 | 941 | ||||||
Total current assets |
31,051 | 28,781 | ||||||
Property, plant and equipment (net) |
408 | 165 | ||||||
Total assets |
31,459 | 28,946 | ||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
1,723 | 1,101 | ||||||
Accrued and other current liabilities |
4,132 | 4,797 | ||||||
Warrants liability |
680 | 37 | ||||||
Total current liabilities |
6,535 | 5,935 | ||||||
Total liabilities |
6,535 | 5,935 | ||||||
Commitments and contingencies |
||||||||
Stockholders’ equity: |
||||||||
Preferred stock, $0.001 par value; 5,000,000
shares authorized at December 31, 2010 and
September 30, 2011; 1,213,142 shares issued and
outstanding at December 31, 2010 and September
30, 2011; Aggregate preference in liquidation
(including undeclared cumulative dividends) of
$13,344,562 and 13,526,533 at December 31, 2010
and September 30, 2011, respectively. |
1 | 1 | ||||||
Common stock, $0.001 par value; 100,000,000
shares authorized at December 31, 2010 and
September 30, 2011, respectively; 46,564,914 and
54,212,643 shares issued and outstanding at
December 31, 2010 and September 30, 2011,
respectively |
47 | 55 | ||||||
Additional paid in capital |
266,666 | 276,312 | ||||||
Accumulated other comprehensive loss |
31 | 49 | ||||||
Deficit accumulated during the development stage |
(241,821 | ) | (253,406 | ) | ||||
Total stockholders’ equity |
24,924 | 23,011 | ||||||
Total liabilities and stockholders’ equity |
31,459 | 28,946 | ||||||
SOURCE: Cyclacel Pharmaceuticals, Inc.
7