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Cyclacel Pharmaceuticals Reports Fourth Quarter And Full Year 2012 Financial Results

Stocks in this article: CYCC

Cash and cash equivalents totaled $16.4 million as of December 31, 2012. Cyclacel 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.

Conference call and Webcast Information:

Cyclacel will conduct a conference call on March 27, 2013 at 4:30 p.m. Eastern Time to review the fourth quarter and year-end 2012 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) 585-8367 / international archive: (404) 537-3406 Code for live and archived conference call is 19638297

For the live and archived webcast, please visit the Corporate Presentations and Events page on the Cyclacel website at www.cyclacel.com . The webcast will be archived for 90 days and the audio replay for 7 days.

About sapacitabine

Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently being studied in SEAMLESS, an ongoing, Phase 3, registration-directed trial in elderly patients aged 70 years or older with newly diagnosed AML who are not candidates for or have refused induction chemotherapy. Sapacitabine is also the subject of Phase 2 trials in patients with hematological malignancies, including AML, myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic lymphocytic leukemia and small lymphocytic lymphoma, and non-small cell lung cancer (NSCLC), and a Phase 1 trial in combination with seliciclib in patients with advanced solid tumors. Sapacitabine acts through a novel DNA single-strand breaking mechanism, leading to production of DNA double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs cause cell death. Repair of sapacitabine-induced DSBs is dependent on the homologous recombination DNA repair (HRR) pathway. Both sapacitabine and CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in preclinical studies.

Over 650 patients have received sapacitabine in clinical studies in patients with AML, MDS, CTCL, NSCLC, hematological malignancies and solid tumors. At the 2012 ASH Annual Meeting, data from the pilot study and lead-in phase of SEAMLESS showed promising response rate, overall survival and low 30-day and 60-day mortality in elderly patients with AML aged 70 years or older receiving sapacitabine alternating with decitabine. Data, presented at The Eighth Annual Hematologic Malignancies 2012 Conference, from an ongoing, multicenter, Phase 2 randomized trial of single-agent oral sapacitabine capsules in older patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine and/or decitabine, showed sapacitabine nearly doubled expected survival of elderly patients with MDS after front-line therapy failure. Results 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, were published in The Lancet Oncology in November 2012. In a Phase 1 study, sapacitabine, in combination with Cyclacel's seliciclib, showed antitumor activity in cancer patients found to be carriers of BRCA mutations. The 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, Cyclacel's most advanced product candidate, is the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly, and other studies for myelodysplastic syndromes (MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic cancer. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on 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 product candidates, 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 other filings we file 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.

© Copyright 2013 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc. ISTODAX® is a trademark of Celgene Corporation.

 
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
(Unaudited)
 
Three Months Ended December 31, Year Ended December 31, Period from August 13, 1996 (inception) to December 31,
  2011 2012 2011 2012 2012
Revenues:          
Collaboration and research and development revenue  $ —  $ —  $ —  $ —  $ 3,100
Grant revenue   —  5  — 69 3,717
Total revenues  —  5 69 6,817
Operating expenses:          
Research and development  2,201  1,996 9,206 6,592 192,391
Selling, general and administrative  1,406  2,663 6,542 8,580 89,411
Goodwill and intangible impairment   —   —  —  — 2,747
Restructuring costs   —   —  —  — 2,634
Total operating expenses  3,607  4,659 15,748 15,172 287,183
Operating loss  (3,607)  (4,654) (15,748) (15,103) (280,366)
Other income (expense):          
Costs associated with aborted 2004 IPO  —  — (3,550)
Payment under guarantee  —  — (1,652)
Non-cash consideration with stock purchase agreement  —  (423) (423) (423)
Change in valuation of Economic Rights  —  (50) (23) (23)
Change in valuation of other liabilities measured at fair value    (34)  — 609 51 6,378
Foreign exchange (losses)/gains   (15)  55 (74) 292 (4,005)
Interest income   12  5  45 22 13,747
Interest expense   —   —  —  — (4,567)
Other income   —    —  — 77 77
Total other income (expense).  (37)   (413) 580 (4) 5,982
Loss from continuing operations before taxes  (3,644)  (5,067) (15,168) (15,107) (274,384)
Income tax benefit   122  637  565 1,351 19,795
Net loss from continuing operations  (3,522)  (4,430) (14,603) (13,756) (254,589)
Discontinued operations:          
(Loss) income from discontinued operations, net of tax of $0 for the three months and year ended December 31, 2011 and $337 for the three months and year ended December 31, 2012  (136)  (334) (640) 570 (12,146)
Net loss  (3,658)  (4,764) (15,243) (13,186) (266,735)
Dividends on preferred ordinary shares  —  — (38,123)
Deemed dividend on convertible exchangeable preferred shares   —   —  —   — (3,515)
Dividend on convertible exchangeable preferred shares   (182)    (182)  (728) (728)  (4,385)
Net loss applicable to common shareholders  $ (3,840)  $ (4,946)  $ (15,971)  $ (13,914)  $ (312,758)
Net loss per share, continuing operations – Basic and diluted  $ (0.48)  $ (0.55)  $ (2.13)  $ (1.75)  
Net income (loss) per share, discontinued operations – Basic and diluted  $ (0.02)  $ (0.04)  $ (0.09)  $ 0.07  
Net loss per share – Basic and diluted  $ (0.50)  $ (0.59)  $ (2.22)  $ (1.68)  
Weighted average common shares outstanding  7,673,096  8,429,269  7,185,877  8,291,802  
 
 
CYCLACEL PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In $000s, except share amounts)
(Unaudited)
 
  As of December 31 As of December 31
  2011 2012
ASSETS    
Current assets:    
Cash and cash equivalents  $ 24,449  $ 16,412
Prepaid expenses and other current assets  1,069  1,599
Current assets of discontinued operations  313  861
Total current assets  25,831  18,872
Property, plant and equipment (net)  167  129
Long-term assets of discontinued operations  —  353
Total assets  $ 25,998  $ 19,354
     
LIABILITIES AND STOCKHOLDERS' EQUITY    
Current liabilities:    
Accounts payable  $ 1,717  $ 2,259
Accrued liabilities and other current liabilities  4,183  5,601
Economic rights  —  1,120
Other liabilities measured at fair value  71  20
Current liabilities of discontinued operations  527  335
Total current liabilities  6,498  9,335
Total liabilities  6,498  9,335
Stockholders' equity:    
Preferred stock, $0.001 par value; 5,000,000 shares authorized at December 31, 2011 and December 31, 2012; 1,213,142 shares issued and outstanding at December 31, 2011 and December 31, 2012. Aggregate preference in liquidation of $13,708,505 and $14,436,390 at December 31, 2011 and December 31, 2012, respectively  1  1
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2011 and December 31, 2012; 7,745,780 and 8,686,484 shares issued and outstanding at December 31, 2011 and December 31, 2012, respectively  8  9
Additional paid-in capital  276,498  280,211
Accumulated other comprehensive loss  57  48
Deficit accumulated during the development stage  (257,064)  (270,250)
Total stockholders' equity  19,500  10,019
Total liabilities and stockholders' equity  $ 25,998  $ 19,354
CONTACT: Investors/Media:
         Corey Sohmer
         (908) 517-7330
         csohmer@cyclacel.com

Cyclacel Pharmaceuticals logo

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