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CYCLACEL COMPLETES $39 MILLION PRIVATE PLACEMENT Funds to Support Growing Clinical Pipeline and Preclinical Programs; Total Raised To Date Exceeds $100 MillionDundee, UK, 29 January 2004 - Cyclacel Limited, the UK-based biopharmaceutical company, announced today the completion of a $39 (£21.3) million Series D private placement with a global syndicate of new and existing institutional investors. Spiro Rombotis, CEO of Cyclacel said, "Completion of this private placement is an important endorsement of our strategy for building an innovative product portfolio and of the progress we have made in advancing our development candidates. Thanks to the talent and dedication of our employees and the support of our investors we have an exciting pipeline of nine small molecule drug programs, seven of which were discovered in-house and two in-licensed. Two of these are in the clinic in the US and Europe supported by our state-of-the-art biomarker technology and a third is scheduled to enter Phase I this year." The placement, which was oversubscribed, involved 20 institutional investors and also certain individuals and managers. New investors were Société Générale Asset Management Alternative Investments (France) together with Carnegie Fund (Sweden), DC Thomson & Co (UK), NIF Ventures (Japan), Quest for Growth (Belgium) and UOB Venture Technology Investments (Singapore). Returning investors were BankInvest Asset Management (Denmark), Biomedical Sciences Investment Fund-EDB Investments (Singapore), Finsbury Life Sciences Investment Trust (UK), International Life Sciences (HBM Partners) (Switzerland), INVESCO Private Capital (USA) Lloyds Development Capital (UK), GeneChem Management (Canada), Merifin Capital (Belgium), Merlin Biosciences (UK), Noble Grossart (UK), Northern Ventures (UK), Quester Capital Management (UK), Scottish Equity Partners (UK) and Temasek Holdings (Singapore). Paul McBarron, CFO of Cyclacel said, "We are delighted with the result of our fundraising effort and the support we received from an international syndicate of new and existing investors. This latest round brings the aggregate amount raised from private equity sources since starting operations 6 years ago to approximately $123 million. To our knowledge we are the first European university spin-out ever to raise over $100 million in private equity." Specifically, the net proceeds to the Company after expenses will be used to advance development of Cyclacel's two clinical stage drugs as well as progressing Cyclacel's preclinical drug portfolio. The Company's lead drug, CYC202 (R-roscovitine, an oral CDK inhibitor), is presently in two Phase IIa trials in combination with gemcitabine and cisplatinum in patients with Non-Small Cell Lung (NSCLC) cancer and with capecitabine in breast cancer. CYC202 is also being explored for use in glomerulonephritis, an inflammatory disease associated with kidney cell proliferation. The second clinical stage compound, CYC682 (an oral nucleoside analogue), completed Phase I trials in cancer patients and is presently entering further Phase I/II studies in oncology. Cyclacel's preclinical stage programs include several small molecule classes being developed for oncology, HIV/AIDS and Type II diabetes indications. About Cyclacel ( www.cyclacel.com ) Cyclacel is a biopharmaceutical company that designs and develops small molecule drugs that act on key cell cycle regulators to stop uncontrolled cell division in cancer and other diseases involving abnormal cell proliferation. Cyclacel's discovery engines integrate cell cycle biology expertise with a large library of gene-based targets, state-of-the-art RNAi functional genomics, chemogenomics and clinical biomarker technologies to rapidly deliver new drugs. The Company has nine research and development programs underway. Most advanced is CYC202, a Cyclin Dependent Kinase (CDK) inhibitor, in Phase II trials for breast and lung cancer. CYC202 has completed Phase I trials in Europe with evidence of potential clinical benefit and is also being explored for use in glomerulonephritis, an inflammatory disease associated with kidney cell proliferation. CYC682, a nucleoside analogue, has completed Phase I trials in the USA with evidence of potential clinical benefit and was shown in preclinical tests to be superior to the leading nucleoside analogue gemcitabine. Cyclacel has entered into corporate alliances with AstraZeneca, CV Therapeutics, Lorus, Sankyo and a top 5 pharmaceutical major all in the oncology field. DISCLAIMER: Cyclacel cautions you that statements in this document that are not describing historical facts may be forward-looking statements that should not be regarded as a representation by Cyclacel that any of its plans will materialize. Actual results may differ materially from those set forth herein due to the risks and uncertainties inherent in Cyclacel's business including, without limitation, statements about: the progress and timing of its clinical trials; dependence on others or difficulties or delays in clinical development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; expanding into other disease indications and its ability to obtain additional financing when needed and on reasonable terms to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement. Other than its obligations to its shareholders, Cyclacel undertakes no obligation to revise or update forward-looking statements, whether as a result of new information, future events or otherwise to reflect events or circumstances after the date hereof. ### Notes to Editors: CYC202 (R-roscovitine) is a novel cell cycle drug belonging to the Cyclin Dependent Kinase (CDK) inhibitor class. CDK inhibition is an important new approach in the quest for drugs that target the molecular mechanism of the body's own cancer stopping genes. In preclinical studies CYC202 demonstrated high specificity against multiple CDKs. It is supplied in capsules and is the first drug in its class that is available by mouth. Results of Phase I trials in about 80 patients with different types of cancer suggest that CYC202 is well tolerated with evidence of potential clinical benefit in terms of response or stable disease. CYC202 has completed a Phase I trial in 24 healthy volunteers and is also being explored for use in glomerulonephritis, an inflammatory disease associated with kidney cell proliferation. CYC202 is currently in Phase IIa trials for breast and lung cancer. CYC682 (1-(2-C-cyano-2-deoxy-ß-D-arabino-pentofuranosyl)-N4-palmitoyl cytosine) CYC682 is an oral prodrug and a novel derivative of 2'-deoxycytidine analogue CNDAC (1-(2-C-cyano-2-deoxy-ß-D-arabino-pentofuranosyl)-cytosine). CYC682's availability by mouth is a feature of few new anticancer drugs increasingly favoured by patients. Knowledge of CYC682's metabolic pathway and its effects on tumour growth offer the possibility of patient specific therapy. Studying appropriate biomarkers affected by CYC682 could aid selection of optimal dose and schedule and could eventually predict treatment outcome. Phase I data from eighty-eight (88) patients with a variety of cancers suggest that CYC682 is well tolerated in man with myelosuppression as dose limiting toxicity. Stable disease was observed in seventeen (17) patients after CYC682 treatment, including one patient with ovarian cancer who experienced a minor response and one patient with a gastrointestinal stromal sarcoma tumour (GIST) who remains on study for over 90 weeks with stable disease after failing multiple therapies. Paul McBarron, 40, joined January 2002. Has 13 years of experience as a financial executive with several pharmaceutical companies. Since 1996 he was a senior member of the finance team at Shire Pharmaceuticals plc where he held the positions of Director, Corporate Finance and Group Financial Controller. He joined Shire when it was an emerging public company employing less than 100 people. Whilst at Shire he made important contributions to all of Shire's acquisition and financing activities, including listing on NASDAQ. He was previously employed at SmithKline Beecham and Sterling Drug and qualified as a chartered accountant with Ernst & Young. Spiro Rombotis, 45, joined August 1997. Has 21 years of experience with pharmaceutical and biotech companies. Previously Vice President, International Operations & Business Development, Managing Director, Europe and Director Japanese joint venture, The Liposome Company, Inc.; Vice President, Pharmaceuticals, Central & Eastern Europe and Director International Marketing, Bristol-Myers Squibb Company; Head European Marketing and Sales, Head Corporate Development, Centocor, Inc.; Business Development, Novartis AG. BA, Williams College, USA. MBA and Master's degree in Hospital Management with honors, Kellogg Graduate School of Management, where he serves on the Advisory Board, Kellogg Center for Biotechnology. © 2004 - Cyclacel Limited. Cyclacel®, Fluorescience®, Penetratin® and Polgen® are registered trademarks. Enquiries: Spiro Rombotis/Paul McBarron, Cyclacel +44 1382 206 062 Richard Anderson/Yvonne Anderson, DeFacto Communications +44 20 7496 3300 Robert Gottlieb, Feinstein Kean Healthcare +1 617 577 8110 |
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